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Abbreviations and Acronyms

Everything you always wanted to know (but were afraid to ask): Abbreviations, acro­nyms, jargon, and symbols seen – not only – in the BEBA-Forum.
Non-English terms are typeset in italics.

• A        

  Term	Meaning
  a	annum (SI: year) atto (10–18 prefix of the SI)
  A	Test treatment in a 2×2×2 crossover design (in comparative BA commonly denoted T)
  AAA	Amino acid analysis
  AAAS	American Association for the Advancement of Science
  AAM	Association for Accessible Medicines (US; until 2017 GPhA)
  AAPS	American Association of Pharmaceutical Scientists
  Ab	Antibody
  ABCM	AUC below \(\textsf{C}_\textsf{min,ss}\)
  ABE	(Conventional, unscaled) Average Bioequivalence
  ABEL	Average BE with Expanding Limits (EEA, HC, EEU, WHO, …)
  AC	Anticoagulant
  ACC	Accuracy
  ACCSQ	Consultative Committee for Standards and Quality (ASEAN states)
  ACE	Angiotensin-converting enzyme
  ACEI	Angiotensin Converting Enzyme Inhibitor
  ACK	Acknowledge(d)
  ACN	Acetonitrile
  ACPSCP	Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (FDA)
  ACRO	Association of Clinical Research Organizations
  ACTA	Anti-Counterfeiting Trade Agreement
  ADaM	Analysis Data Model (of the CDISC)
  ADC	Antibody Drug Conjugate
  ADCC	Antibody-dependent Cell-mediated Cytotoxicity
  ad lib	ad libitum (as desired, freely)
  ADME	Absorption, Distribution, Metabolism, Excretion
  ADR	Adverse Drug Reaction
  AE	Adverse Effect Adverse Event
  AED	Anti-epileptic Drug
  Aet	Cumulative amount excreted to the last sampling interval
  AEMPS	Agencia Española de Medicamentos y Productos Sanitarios (Agency of Medicines and Medical Devices, competent authority of Spain)
  AFAIK	As far as I know
  AFSSAPS	Agence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products; since May 2012 ANSM)
  Ag	Antigen
  AGAH	Arbeitsgemeinschaft für Angewandte Humanpharmakologie (Association for Applied Human Phar­ma­co­logy, Germany)
  AGES	Österreichische Agentur für Gesundheit und Ernährungssicherheit (Austrian Agency for Health and Food Safety)
  AI	Artificial (Un‽)Intelligence
  AIC	Akaike Information Criterion
  aka	also known as
  ALCOA	Attributable, legible, contemporaneous, original and accurate
  ALT	Alanine aminotransferase
  AMA	American Medical Association
  AMIP	Moroccan Association for the Pharmaceutical Industry
  AMS	Accelerator Mass Spectrometry
  ANAFAM	Asociación Nacional de Fabricantes de Medicamentos (National Association of Medicines Manu­facturers, Mexico)
  ANAMED	Agencia Nacional de Medicamentos (National Medicines Agency, Chile)
  ANCOVA	Analysis of Covariance
  ANDA	Abbreviated New Drug Application (FDA term)
  ANMAT	Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Admini­stra­tion for Medicines, Food and Medical Technology, Argentina)
  ANOVA	Analysis of Variance (aka AOV)
  ANPP	Agence Nationale des Produits Pharmaceutiques (National Agency of Pharmaceutical Pro­ducts, Algeria)
  ANSI	American National Standards Institute
  ANSM	Agence nationale de sécurité du médicament et des produits de santé (National Drug and Health Products Safety Agency, competent authority of France; until April 2012 AFSSAPS)
  ANVISA	Agência Nacional de Vigilância Sanitária (National Agency for Sanitary Monitoring, Brazil)
  AOAC	Association of Official Analytical Chemists (US)
  AOV	Analysis of Variance (aka ANOVA)
  a.p.	ante prandium (before a meal)
  AP, A&P	Accuracy and Precision (BMV)
  APCI	Atmospheric Pressure Chemical Ionization (MS)
  APEC	Asia-Pacific Economic Cooperation
  APhA	Academy of Pharmaceutical Sciences (US) American Pharmacists Association
  API	Active Pharmaceutical Ingredient Application programming interface
  APV	Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik (Association for Phar­ma­ceu­tical Technology, Germany)
  AR	Acceptance Range Adverse Reaction
  ARE	Amount Remaining to be Excreted
  ARGOM	Australian Regulatory Guideline for OTC Medicines
  ARGPM	Australian Regulatory Guidelines for Prescription Medicines
  ARO	Academic Research Organization
  ASA	American Statistical Association
  ASAP	As soon as possible (for your health: As slow as possible)
  ASCII	American Standard Code for Information Interchange
  ASEAN	Association of Southeast Asian Nations (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myan­mar, Philippines, Singapore, Thailand, Vietnam)
  ASMS	American Society for Mass Spectrometry
  ASN	Average Total Sample Size (in a TSD)
  AST	Aspartate aminotransferase
  AT	Ambient temperature
  ATC	Anatomical Therapeutic Chemical (Classification System by the WHO)
  ATMP	Advanced-Therapy Medicinal Product
  ATP	Adenosine triphosphate
  AUC	Analytical Ultracentrifugation Area Under the concentration vs. time Curve \(=\int \textsf{C}(\textsf{t})d \textsf{t}\)
  AUCall	AUClast plus the area of a triangle given by \(\textsf{t}_\textsf{last}|\textsf{C}_\textsf{last}\) and \(\textsf{t}_{\textsf{last}+1}|\textsf{C}=0\) (a questionable invention by Certara; should be avoided)
  \(\textsf{AUC}_\textsf{apical}\)	Average of AUCs within POT-25
  \(\textsf{AUC}_\textsf{extrap}\)	Extrapolated part of the AUC; commonly in percent \(100(\textsf{AUC}_{0-\infty}-\textsf{AUC}_{0-\textsf{t}})/\textsf{AUC}_{0-\infty}\)
  \(\textsf{AUC}_\textsf{t}\)	AUC from t = 0 to the time point of the last measured concentration (also \(\textsf{AUC}_\textsf{0–t}\), \(\textsf{AUC}_{\textsf{t}_\textsf{last}}\), \(\textsf{AUC}_{\textsf{t}_\textsf{z}}\), AUClast)
  \(\textsf{AUC}_\textsf{τ}\)	AUC within one dosing interval \(\textsf{τ}\) in steady state (also \(\textsf{AUC}_{0-\textsf{τ}}\))
  \(\textsf{AUC}_\infty\)	AUC from t = 0 to infinite time (also \(\textsf{AUC}_{0-\infty}\), AUCinf)
  \(\textsf{AUEC}\)	Area Under the Effect Curve
  \(\textsf{AUMC}\)	Area Under the first Moment of the Curve \(=\int \textsf{t}\cdot \textsf{C}(\textsf{t})d \textsf{t}\)

• B                

  Term	Meaning
  B	Reference treatment in a 2×2×2 crossover design (in comparative BA commonly denoted R)
  BA	Bioanalysis Bioavailability
  BABP	Network On Bioavailability And Biopharmaceutics (EUFEPS)
  BAN	British Adopted Name
  BAPI	Bangladesh Association of Pharmaceutical Industries
  BASG	Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, Austria)
  BBB	Blood–brain barrier
  BBBB	(Balaton, Bosporus, Bled, Baltic) Conference Series
  BCS	Biopharmaceutics Classification System
  BDDCS	Biopharmaceutics Drug Disposition Classification System
  BE	Bioequivalence (NB, there are no ‘BE studies’ – BE is the desired result of a comparative BA study)
  bear	A furry omnivorous mammal of the family Ursidae Package BEBA for
  BE NOC	Bioequivalence No Objection Certificate (CDSCO term)
  BEWGG	Bioequivalence Working Group for Generics (of the IPRP)
  BfArM	Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medi­cal Devices, competent authority of Germany; until 1994 BGA)
  BGA	Bundesgesundheitsamt (Federal Health Office, Germany; rebranded in 1994 to BfArM)
  BIBD	Balanced Incomplete Block Design
  BIC	Bayesian Information Criterion (aka SBC)
  BID	bis in die (twice a day)
  BLA	Biologics License Application (FDA term)
  BLQ	Below the LOQ (not quantifiable)
  BLUE	Best Linear Unbiased Estimator
  BMI	Body Mass Index
  BMV	Bioanalytical Method Validation
  BMWP	Biosimilar Medicinal Products Working Party (of the EMA)
  BP	Blood pressure
  BPFK	Biro Pengawalan Farmaseutikal Kebangsaan (National Pharmaceutical Control Bureau, Malaysia)
  BQL	Below Quantification Limit
  B-R	Benefit-Risk
  BS	Blood Sugar
  BSA	Body Surface Area Bovine Serum Albumin
  BSCV	Between-subjects CV (also CVB, CVinter)
  BS	Blood Sugar
  BSI	Body Shape Index
  BSWP	Biostatistics Working Party (of the CHMP); merged 2022 with other working parties in the MWP
  BTIF	Bioequivalence Trial Information Form (WHO)
  BTW	By the way
  BW	Biowaiver Body Weight
  BWG	Biosimilars Working Group (of the IPRP)
  BWP	Biologics Working Party (of the EMA)
  BZD	Benzodiazepine

• C                

  Term	Meaning
  \(\textsf{C}\)	(Measured, observed) concentration
  \(\widehat{\textsf{C}}\)	Estimated concentration
  \(\widehat{\textsf{C}}_\textsf{0}\)	Intercept in the log-linear estimation of \(\widehat{\lambda}_\textsf{z}\)
  ca.	circa (approximately)
  CA	Competent Authority
  Caco-2	Human colon adenocarcinoma cell line
  cAMP	Cyclic adenosine monophosphate
  CAP	Centrally Authorised Product (EMA)
  CAPA	Corrective and Preventive Action
  \(\textsf{C}_\textsf{apical}\)	Average of concentrations within POT-25
  CAP	Centrally Authorised Product (in the EEA)
  CAS	Chemical Abstracts Service Computer Algebra System
  CAT	Committee for Advanced Therapies (of the EMA)
  \(\textsf{C}_\textsf{av,ss}\)	Average concentration in steady state \(=\textsf{AUC}_{0-\textsf{τ}}/\textsf{τ}\)
  CBER	Center for Biologics Evaluation and Research (of the FDA)
  CC	Calibration Curve Creative Commons (license) CC-BY Attribution, no restrictions CC-BY-NCAttribution, non-commercial CC-BY-NDAttribution, no derivatives CC-BY-SAAttribution, share alike CC-BY-NC-NDAttribution, non-commercial, no derivatives CC-BY-NC-SAAttribution, non-commercial, share alike
  CD	Circular Dichroism
  CDD	Critical Dose Drug
  CDE	Center For Drug Evaluation (Taiwan)
  CDER	Center for Drug Evaluation and Research (of the FDA)
  CDF	Cumulative Distribution Function
  CDISC	Clinical Data Interoperability Standards Consortium
  CDMO	Contract, Development and Manufacturing Organization
  CDS	Chromatography Data System
  CDSCO	Central Drugs Standard Control Organization (India)
  CE	Capillary Electrophoresis Clinical Endpoint
  CECMED	Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (Center for State Control of Medicines, Equipment, and Medical Devices, Cuba)
  CEP	Clinical Endpoint
  CET	Central European Time (UTC+1)
  CEST	Central European Summer Time (UTC+2)
  CFDA	China Food & Drug Administration (formerly SFDA)
  CEX	Cation Exchange
  CFR	Code of Federal Regulations (US)
  cGMP	Current GMP(s) Cyclic guanosine monophosphate
  CGPA	Canadian Generic Pharmaceutical Association
  CHMP	Committee for Medicinal Products for Human Use (of the EMA; until 2004 CPMP)
  CHO	Carbohydrate
  CI	Chemical Ionization (MS) Confidence Interval Contraindication
  CILFA	Cámara Industrial de Laboratorios Farmacéuticos Argentinos (Argentinian Generic and Bio­similar Pharmaceutical Manufacturers Association)
  CIOMS	Council for International Organizations of Medical Sciences
  CIP	Cahn–Ingold–Prelog priority rules
  CL	Clearance Confidence Limit
  \(\textsf{C}_\textsf{last}\)	Last measured concentration of the profile
  \(\widehat{\textsf{C}}_\textsf{last}\)	Estimated last concentration of the profile
  CL/ƒ	Apparent Clearance after extravascular administration
  CLIA	Clinical Laboratory Improvement Amendments
  \(\textsf{C}_\textsf{max},\,\textsf{C}_\textsf{max,ss}\)	Maximum concentration (single dose, steady state); observed in NCA, estimated by PK modeling
  CMC	Chemistry, Manufacturing, and Controls
  CMDh	Co-ordination group for Mutual recognition and Decentralised procedures – human (of the EEA; until 2005 MRFG)
  \(\textsf{C}_\textsf{min,ss}\)	Minimum concentration in steady state (also \(\textsf{C}_\textsf{trough}\))
  CMS	Concerned Member State (in European MRP)
  CMV	Critical Model Variable
  CNS	Central Nervous System
  CO	Carryover
  CoA	Certificate of Analysis
  CoC	Code of Conduct
  COFEPRIS	Comisión Federal para la Protección contra Riesgos Sanitarios (Federal Commission for Pro­tection against Health Risks, Mexico)
  COI	Conflict of interest
  COMP	Committee for Orphan Medicinal Products (of the EMA)
  CONSORT	Consolidated Standards of Reporting Trials
  COPD	Chronic Obstructive Pulmonary Disease
  COST	European Cooperation in Science and Technology
  COSTART	Coding Symbols for a Thesaurus of Adverse Reaction Terms (FDA; replaced by the MedDRA)
  COTS	Commercial off-the-shelf
  CP	Centralised Procedure (of the EEA) Concept Paper
  CPD	Citrate Phosphate Dextrose (AC)
  CPDA	Citrate Phosphate Dextrose Adenine (AC)
  CPMP	Committee for Proprietary Medicinal Products (of the EMA; since 2004 CHMP)
  CPPS	Center for Pharmaceutical Products Safety, Uzbekistan
  CQA	Critical Quality Attribute
  CR	Controlled Release MR product (also LA, SR, XR)
  CRA	Clinical Research Associate
  CRAN	Comprehensive Archive Network
  CRF	Case Report Form
  CRM	Continual Reassessment Method
  CRO	Contract Research Organization
  CRP	Conditional Rejection Probability
  CSV	Character Separated Variables (originally: Comma Separated Variables)
  CSF	Cerebrospinal Fluid
  CSP	Clinical Study Protocol
  CSR	Clinical Study Report
  CSS	Cascading Style Sheet
  CT	Clinical Trial Computed tomography (scan)
  \(\textsf{C}_\textsf{τ}\)	Concentration at intended dosing interval \(\textsf{τ}\) after a single dose
  \(\textsf{C}_{\textsf{τ},\textsf{ss}}\)	Concentration at the end of the dosing interval \(\textsf{τ}\) in steady state
  CTA	Clinical Trial Application
  CTC	Common Toxicity Criteria
  CTCAE	Common Terminology Criteria for Adverse Events
  CTD	Clinical Trials Directive (EU) Common Technical Document (according to ICH)
  CTM	Clinical Trial Manager
  CTR(I)	Clinical Trial Registry (India)
  \(\textsf{C}_\textsf{trough}\)	\(\textsf{C}_\textsf{min,ss}\) (in PK) \(\textsf{C}_{_{\textsf{τ},\textsf{ss}}}\) (in the EMA’s guideline)
  CV	Cardiovascular Coefficient of Variation Curriculum vitae (résumé)
  CVG	Calibration and Validation Group
  CVinter	Between-subjects CV estimated in a crossover design (aka CVB, BSCV)
  CVintra	Within-subjects CV estimated in a crossover design (aka CVW, ISCV)
  CVtotal	CV estimated in a parallel design (aka CVpooled)
  CVwR	Within-subjects CV of the Reference product estimated in a replicate design
  CVwT	Within-subjects CV of the Test product estimated in a fully replicated design
  CYP	Cytochrome Pigment

• D                

  Term	Meaning
  d	Day deci (10–1 prefix of the SI)
  d	dextro enantiomer, according to IUPAC (+)
  D	Dose
  DABERS	Data Anomalies in BioEquivalence R Shiny (a tool of the FDA)
  DAD	Diode Array Detector (LC)
  DAR	Drug-antibody ratio
  DB	Database
  DBE	Division of Bioequivalence (FDA/OGD)
  DBP	Diastolic blood pressure
  DBS	Dried Blood Spot
  DCD	Drug Control Division (competent authority of Thailand)
  DCGI	Drug Controller General of India
  DCL	Data Control Language (of SQL)
  DCP	Decentralised Procedure (in the EEA)
  DCR	Division of Clinical Review (FDA/OGD)
  DCS	Developability Classification System
  DDD	Defined daily dose (WHO term)
  DDI	Drug-Drug Interaction
  DDL	Data Definition Language (of SQL)
  DDT	Drug Development Tool
  DE	Dissolution Efficiency
  DES	Drug-eluting stent
  DESI	Drug efficacy study implementation
  df	Degree(s) of freedom (also \(\nu\))
  DGDA	Directorate General of Drug Administration (competent authority of Bangladesh)
  DHMA	Danish Health and Medicines Authority (in 2012 merged from DKMA and the National Board of Health)
  DIA	Drug Information Association
  DII	Director of Investigating Institute (GLP)
  DINAVISA	Dirección National de Vigilancia Sanitaria (National Health Surveillance Directorate, Paraguay)
  DKMA	Danish Medicines Agency (since 2012 DHMA)
  DL	Delayed Release (product) Detection Limit (also LOD)
  DLP	Data Lock Point
  DLS	Dynamic Light Scattering
  DLT	Dose Limiting Toxicity
  DMC	Data Monitoring Committee
  DM	Mahalanobis Distance (also MD)
  DMF	Drug Master File
  DML	Data Manipulation Language (of SQL)
  DMS	Document Management System
  DMPK	Drug Metabolism and Pharmacokinetics
  DNFTT	Do not feed the Troll
  DO(R)	Dropout (rate)
  DOI	Digital Object Identifier
  DP	Drug Product
  DQ	Design Qualification
  DQC	Dilution Quality Control
  DQL	Data Query Language (of SQL)
  DR	Delayed Release
  DRF	Data Resolution Form
  DS	Drug Substance
  DSC	Differential Scanning Calorimetry
  DSMB	Data Safety Monitoring Board
  DST	Daylight saving time
  D-U-N-S	Data Universal Numbering System
  DV	Dependent variable

• E                

  Term	Meaning
  E	Effect
  EA	Ethyl acetate (aka EtOAc)
  EAC	East African Community (Democratic Republic of the Congo, Federal Republic of Somalia, Republics of Burundi, Kenya, Rwanda, South Sudan, Uganda, and Tanzania)
  EACPT	European Association for Clinical Pharmacology and Therapeutics
  EAEU, EEU	Eurasian Economic Union (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia)
  EBE	European Biopharmaceutical Enterprises
  EBF	European Bioanalysis Forum
  EBM	Evidence-based medicine
  EC	Enteric coated Ethics Committee European Commission European Community (since 2009 EU)
  EC50	Median Effective Concentration
  ECD	Electrochemical Detector (LC) Electron Capture Detector (GC)
  ECG	Electrocardiography, Electrocardiogram
  ECHI	European Core Health Indicators of the EC
  eCRF	Electronic Case Report Form
  eCTD	Electronic Common Technical Document
  ED	Erectile dysfunction
  ED50	Median Effective Dose
  EDA	Egyptian Drug Authority Exploratory Data Analysis
  EDC	Electronic Data Capturing
  EDCS	Electronic Data Capture System
  EDF	Empirical Distribution Function
  EDL	Estimate of the Detection Limit (EPA term)
  EDMS	Electronic Data Management System
  EDQM	European Directorate for the Quality of Medicines & HealthCare
  EDTA	Ethylenediaminetetraacetic acid (AC)
  EEA	European Economic Area (EU + Iceland, Liechtenstein, Norway)
  EEC	Commission of the EEU
  EEG	Electroencephalography, Electroencephalogram
  EFPIA	European Federation of Pharmaceutical Industries and Associations
  e.g.	exempli gratia (for example)
  EGA	European Generic Medicines Association (since 2016 MfE)
  EI	Electron Impact Ionization (MS)
  EIR	Establishment Inspection Report (FDA)
  ELISA	Enzyme Linked Immunosorbent Assay
  ELS	Evaporative Light Scattering
  EM	Emission wavelength (FL) Extensive metabolizer (also FM)
  EMA	European Medicines Agency (until 2005 EMEA)
  Emax	Maximum Effect
  EMEA	European Agency for the Evaluation of Medicinal Products (rebranded in 2005 to EMA)
  EMG	Exponentially Modified Gaussian
  EMIT	Enzyme Multiplied Immunoassay Technique
  EML	Essential Medicines List (WHO)
  EOB	Electronic Orange Book (FDA)
  EOD	End of discussion Every other day
  EORI	Economic Operators Registration and Identification number (EU)
  EPA	Environmental Protection Agency (US)
  EPAR	European Public Assessment Report
  EPO	Erythropoietin
  ER	Extended Release (MR product)
  ES	Eligible subject
  ESI	Electrospray Ionization (MS)
  ESV	End of Study Visit
  et al.	et alii (and others)
  ETASU	Elements to Assure Safe Use (FDA term)
  EtOAc	Ethyl acetate (aka EA)
  EtOH	Ethanol
  EU	European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxem­bourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden; 01/2020 United Kingdom)
  EUCROF	European CRO Federation
  EudraCT	EU Drug Regulating Authorities Clinical Trials
  EudraLex	Collection of rules and regulations governing medicinal products in the EU
  EudraNet	EU Drug Regulating Authorities Network
  EudraGMDP	EEA Good Manufacturing / Distribution Practice Database
  EudraPharm	EU Drug Regulating Authorities Pharmaceutical Database
  EUFEPS	European Federation for Pharmaceutical Sciences
  EULA	End-user license agreement (aka software license agreement)
  EUnetHTA	European Network for Health Technology Assessment
  EV	Extravascular (also ev)
  EWG	Expert Working Group (of the ICH)
  EWP	Efficacy Working Party (of the EMA)
  EX	Excitation wavelength (FL)

• F                

  Term	Meaning
  f	femto (10–15 prefix of the SI)
  f	Fraction absorbed (AUCev/AUCiv)
  F	f given in percent
  f1	Difference factor (comparing dissolution profiles)
  f2	Similarity factor (comparing dissolution profiles)
  FAIMS	Field Asymmetric Waveform Ion Mobility Spectrometry
  FA	Formic acid
  FAQ	Frequently Asked Question
  FAERS	FDA Adverse Event Reporting System
  FaSSIF	Fasted-State Simulated Intestinal Fluid
  FAT	Factory Acceptance Test
  FC(MP)	Fixed Combination (Medicinal Product)
  FDA	(United States) Food and Drug Adminstration
  FDASIA	Food and Drug Administration Safety and Innovation Act (US)
  FDC	Fixed-Dose Combination (Product)
  FDF	Finished Dosage Form
  FDR	False Discovery Rate
  FeSSIF	Fed-State Simulated Intestinal Fluid
  FEV1	Forced Expiratory Volume in one second
  FFF	Field Flow Fractionation
  FFT	Fast Fourier Transformation
  FG	Focus group
  FID	Flame Ionization Detector in GC
  FIM	First-In-Man (also FIH – First in Human)
  FIP	Fédération internationale pharmaceutique (International Pharmaceutical Federation)
  FL(D)	Fluorescence (Detection) in LC
  FM	Fast metabolizer (also EM)
  FNR	False Negative Rate (β, probability of Type II Error)
  FOB	Follow-on Biologic
  FOCE	First Order Conditional Estimation method in PopPK
  FOIA	Freedom of Information Act (US)
  FPIA	Fluorescence Polarization Immunoassay
  FPP	Finished Pharmaceutical Product
  FPR	False Positive Rate (α, probability of Type I Error)
  FSOT	Fused Silica Open Tubular (capillary column in GC)
  FT	Freeze/thaw (BMV)
  FTIR	Fourier Transform Infrared Spectroscopy
  FTP	File Transfer Protocol
  FUM	Follow-up Measures
  FWER	Familywise (Type I) Error Rate

• G                

  Term	Meaning
  g	Standard acceleration due to gravity at the Earth’s surface (SI: 9.80665 m/s²)
  GaBI	Generics and Biosimilars Initiative
  GALP	Good AutomatedLaboratory Practice(s)
  GBC	Global Bioanalysis Consortium
  GBHI	Global Bioequivalence Harmonisation Initiative
  GBMA	Generic and Biosimilar Medicines Association (Australia)
  GC	Gas Chromatography
  GCC	Gulf Cooperation Council (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, the United Arab Emirates)
  GCP	Good Clinical Practice(s)
  GCP IWG	Good Clinical Practice Inspectors Working Group (of the EMA)
  GDP	Good Distribution Practice(s)
  GDPR	General Data Protection Regulation (EU)
  GDUFA	Generic Drug User Fee Act (US)
  GENEZIS	Serbian and Montenegrin Generic and Biosimilar Medicines Association
  G×F	Group-by-Formulation (Interaction)
  GFR	Glomerular filtration rate
  GI(T)	Gastrointestinal (Tract)
  GITT	Gastrointestinal Transit Time
  GL	Guideline
  G(L)C	Gas (-Liquid) Chomatography
  GLM	Generalized Linear Model
  GLP	Good Laboratory Practice(s)
  GMP	Good Manufacturing Practice(s)
  GM(R)	Geometric Mean (Ratio)
  GMT	Greenwich Mean Time (UK)
  GPhA	Generic Pharmaceutical Association (US; merged in 2000 from the GPIA and the NPA and in 2001 with the NAPM, since 2017 AAM)
  GPIA	Generic Pharmaceutical Industry Association (US; merged in 2000 to the GPhA)
  GPL	GNU General Public License
  GPO	(Microsoft’s) Group Policy Object
  GSD	Group-Sequential Design
  GUI	Graphical User Interface
  GVP	Good Pharmacovigilance Practice(s)

• H                

  Term	Meaning
  h	Hour (also hr; non-SI unit)
  H0	Null Hypothesis
  Ha	Alternative Hypothesis (also H1)
  HA	Headache (also H/A) Health Authority
  Hb	H(a)emoglobin (also Hgb)
  HC	Health Canada
  HCP	Healthcare Professional
  HETP	Height Equivalent of Theoretical Plate (in Chromatography)
  HH[:mm][:ss]	ISO 8601 local time format (i.e., without UTC offset Z), where the minutes and seconds are optional; all values are zero-padded (HH: 00–24, mm: 00–59, ss: 00–60, where 60 is only used for an added leap second)
  HILIC	Hydrophilic Interaction Liquid Chromatography
  HMA	Heads of Medicines Agencies (of the EEA)
  HMPC	Committee on Herbal Medicinal Products (of the EMA)
  hν	Light
  HPAE	High Performance Anion Exchange Chromatography
  HPFB	Health Products and Food Branch (of HC)
  HPLC	High Performance Liquid Chromatography (in the old days High Pressure LC)
  HPTLC	High Performance Thin Layer Chromatography
  HQC	High QC (sample)
  HR	Heart rate
  HSA	Health Sciences Authority (competent authority of Singapore)
  HTA	Health Technology Assessment
  HTML	Hypertext Markup Language
  HTML5	Hypertext Markup Language 5 (latest revision 5.2 of 2017)
  HTTP	Hypertext Transfer Protocol
  HV	Human Volunteer
  HVD	Half Value Duration (time interval where \(\textsf{C}\geq \textsf{50% C}_\textsf{max}\); aka POT-50) Highly Variable Drug
  HVDP	Highly Variable Drug Product

• I                

  Term	Meaning
  IA	Interim Analysis Intra-arterial
  IB	Investigator’s Brochure
  IBD	Incomplete Block Design
  IBE	Individual Bioequivalence
  IBS	International Biometric Society
  IBW	Ideal Body Weight
  IC	Informed Consent Ion Chromatography
  ICBM	Intercontinental Ballistic Missile
  ICD	Informed Consent Document International Classification of Diseases (WHO)
  ICF	Informed Consent Form
  ICH	International Council for Harmonisation (until 10/2015 Inter­na­tio­nal Con­fe­rence on Har­moni­za­tion of Tech­ni­cal Require­ments for the Reg­is­tra­tion of Phar­ma­ceu­ti­cals for Human Use)
  ICH E	Efficacy Guideline of the ICH, e.g.,    3: Structure and Content of CSRs    6: GCP (current revison 3)    8: General Considerations for CTs (current revison 1)    9: Statistical Principles for CTs (current addendum 1)
  ICH M	Multidisciplinary Guideline of the ICH, e.g.,    9: BCS-based Biowaivers 10: BMV 12: Drug Interaction Studies 13: BE for IR Solid Oral Dosage Forms
  ICMR	Indian Council of Medical Research
  ICP/MS	Inductively Coupled Plasma Mass Spectrometry
  ICSR	Individual Case Safety Report
  IDE	Integrated Development Environment
  IDMPWG	Identification of Medicinal Products Working Group (of the IPRP)
  i.e.	id est (that is)
  IE	Inconclusive Evidence
  IEC	Independent Ethics Committee
  IEEE	Institute of Electrical and Electronics Engineers
  IEF	Isoelectric Focusing
  IF	Impact Factor
  IGBA	International Generic and Biosimilars Medicines Association
  IGDRP	International Generic Drug Regulators Programme
  IID	Independent Identically Distributed (Random Variables)
  IIRC	If I (recall/remember) correctly
  IM	Intramuscular (also im)
  IMHO	In my (humble/honest) opinion
  IMI	Innovative Medicines Initiative (EU and EFPIA)
  IMP	Investigational Medicinal Product (EU term)
  IND	Investigational New Drug (FDA term)
  INN	International Nonproprietary Name
  INVIMA	Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of Drug and Food Monitoring, competent authority of Colombia)
  IP	Internet Protocol (address) Investigational Product (ICH GCP term)
  IPA	Indian Pharmaceutical Alliance
  IPAC-RS	International Pharmaceutical Aerosol Consortium on Regulation & Science
  IPD	Individual Patient Data
  IPR	Intellectual Property Rights
  IPRP	International Pharmaceutical Regulators Programme
  IQ	Installation Qualification
  IQR	Interquartile Range (QIII – QI)
  IR	Immediate Release Infrared Inspection Report
  IRB	Institutional Review Board
  IRCTN	International Standard Randomized Controlled Trial Number
  IRLS	Iteratively Reweighted Least Squares
  IS	Internal Standard
  ISBN	International Standard Book Number
  ISCB	International Society for Clinical Biostatistics
  ISCV	Intra-subjects Coefficient of Variation (also CVW, CVintra)
  ISF	Investigator Site File
  ISNI	International Standard Name Identifier
  ISO	International Standards Organization
  ISPR	Incurred Subject Period Re-analysis
  ISR	Incurred Sample Re-analysis (also … Reproducibility)
  ISSN	International Standard Serial Number
  ISTQB	International Software Testing Qualifications Board
  ISV	Internal Standard Variation
  ITT	Intent-to-Treat
  IU	International unit
  IUD	Intrauterine device
  IUPAC	International Union of Pure and Applied Chemistry
  IUPHAR	International Union of Basic and Clinical Pharmacology
  IUT	Intersection-Union Test
  IV	Intravenous (also iv)
  IVIVC	In vitro in vivo correlation
  IVIVR	In vitro in vivo relationship
  IVPT	In vitro permeation test
  IVRS	Interactive Voice Response System
  IVRT	In vitro release test
  IW	Impartial witness
  IWWG	Information Sharing Working Group for Generics (of the IPRP; 2014 – 2020)
  IWRS	Interactive Web Response System

• J                

  Term	Meaning
  JAPM	Jordanian Association of Pharmaceutical Manufacturers
  JFDA	Jordan Food and Drug Administration
  JGA	Japan Generic Medicines Association

• K                

  Term	Meaning
  k	Regulatory constant in ABEL (see also \(\theta_\text{s}\))
  k’	Capacity factor in chromatography \((\textsf{t}_\textsf{R}-\textsf{t}_0)/\textsf{t}_0\)
  \(\textsf{k}_0\)	Infusion rate constant (also \(\textsf{k}_\textsf{in}\))
  \(\textsf{k}_\textsf{a}\)	Absorption rate constant (also \(\textsf{k}_{01}\))
  KASA	Knowledge-aided Assessment & Structured Application
  \(\textsf{k}_\textsf{el}\)	Elimination rate constant (also \(\textsf{k}_{10}\))
  Kel	Elimination rate constant in guidelines (actually \(\widehat{\lambda}_\text{z}\))
  \(\textsf{k}_\textsf{xy}\)	Between compartments rate constant (where \(\textsf{x},\,\textsf{y}\neq 0\))
  KFDA	Korea Food & Drug Administration
  KISS	Keep it simple, stupid
  \(\textsf{K}_\textsf{m}\)	Michaelis-Menten constant
  KR	Kenward-Roger approximation of degrees of freedom

• L                

  Term	Meaning
  l	levo enantiomer, according to IUPAC (–)
  L	Lower limit of the reference-scaled average BE acceptance range (ABEL) \(=e^{-0.76\,\cdot\, s_\text{wR}}\)
  LA	Long Acting (MR product)
  LADME	Liberation, Absorption, Distribution, Metabolism, Excretion
  LALA	Locally applied, locally acting (product)
  LAR	Legally acceptable representative
  LaTeX	Software system for typesetting documents based on TeX
  LBA	Ligand Binding Assay
  LC	Liquid Chromatography
  LDH	Lactate dehydrogenase
  LEC	Local Ethics Committee
  LIF	Laser-induced Fluorescence
  LIMS	Laboratory Information Management System
  LL	Log likelihood
  LLE	Liquid-Liquid Extraction
  LLOQ	Lower Limit of Quantification
  LLT	Lowest Level Term (MedDRA)
  LMEM	Linear Mixed-Effects Model
  LMICs	Low and Middle Income Countries
  LOC	Lines of Code
  LOCF	Last Observation Carried Forward
  LOD	Limit of Detection (also DL)
  \(\text{log}_{e}\)	Natural logarithm (base e ≈ 2.71828…)
  \(\text{log}_{10}\)	Decadic logarithm (base 10)
  LoI	Letter of Intent
  LoOI	List of Outstanding Issues (authored by the CxMP and addressed to the Applicant at ca. day 180)
  LoQ	List of Questions (authored by the CxMP and addressed to the Applicant at ca. day 120)
  LOQ	Limit of Quantification (common meaning LLOQ)
  LoU	Letter of Undertaking
  LQC	Low QC (sample)
  LR	Linear Range Linear Regression Loo-Riegelman (method of estimating absorption)
  LS	Least Squares
  LSM	Least Squares Mean (SAS-lingo, aka Adjusted Mean)

• M                

  Term	Meaning
  m	milli (10–3 prefix of the SI)
  MA	Marketing Authorisation (in the EEA)
  MAA	Marketing Authorisation Application (in the EEA)
  MAD	American humor magazine Mean Absolute Difference Median Absolute Deviation Multiple Ascending Dose
  MAH	Marketing Authorisation Holder (in the EEA)
  MALDI	Matrix-assisted Laser Desorption/Ionization
  MALS	Multi-angle Light Scattering
  MANOVA	Multivariate Analysis of Variance
  MaPP	Manual of Policies and Procedures (FDA/CDER)
  MAR	Missing at random
  MAT	Mean Absorption Time
  MathJAX	JavaScript library to render LaTeX in HTML5
  MatLab	Matrix Laboratory (numeric computing environment)
  MathML	Mathematical Markup Language (application of XML and implemented in HTML5)
  MB	Management Board
  MCAR	Missing completely at random
  MCC	Medicines Control Council (since 2017 SAHPRA)
  mcg	Microgram (non-SI replacement for µg to avoid confusion with mg; acceptable if handwritten)
  MCHC	Mean corpuscular h(a)emoglobin concentration
  MCMC	Markov Chain Monte Carlo
  MCP	Multiple Comparison Procedure
  MCV	Mean corpuscular volume
  MD	Mahalanobis Distance (also DM) Multiple Dose
  MD5	Message-digest 5
  MDC	Minimum Detectable Concentration
  MDI	Metered Dose Inhaler
  MDL	Medical-Diagnostic Laboratory Method Detection Limit (EPA)
  MDR	Medical Device Report (FDA) Multi-drug resistance
  MDT	Mean Dissolution Time Median Duration Time
  ME	Matrix Effect
  MEB	Medicines Evaluation Board (The Netherlands)
  MEC	Minimum Effective Concentration
  MED	Minimum Effective Dose
  MedDRA	Medical Dictionary for Regulatory Activities
  MEDLINE	Medical Literature Analysis and Retrieval System Online (US)
  MEDSAFE	New Zealand Medicines and Medical Devices Safety Authority
  MEM	Mixed Effects Model
  MENA	Middle East and North Africa
  MeOH	Methanol
  MeSH	Medical Subject Headings
  MF	Matrix Factor
  MFDS	Ministry of Food and Drug Safety (competent authority of the Republic of Korea)
  MfE	Medicines for Europe (until 2016 EGA)
  MHLW	Ministry of Health, Labour and Welfare (Japan)
  MHRA	Medicines and Healthcare Products Regulatory Agency (UK)
  MIC	Minimum Inhibitory Concentration
  min	Minimum Minute (non-SI unit)
  MIR	Mean of individual subject ratios
  MIR	Mean of individual subject ratios
  ML	Machine learning
  MLE	Maximum Likelihood Estimator
  M-M	Michaelis-Menten kinetics
  MNAR	Missing not at random
  MoH	Ministry of Health
  MoM	Method of Moments
  MOOSE	Meta-analysis Of Observational Studies in Epidemiology
  MOPI	Malaysian Organisation of Pharmaceutical Industries
  MP	Mobile Phase
  MPA	Medicinal Products Act
  MPH	Metylphenidate
  MQC	Medium QC (sample)
  MR	Metabolic Ratio (AUCparent/AUCmetabolite) Modified Release (product): CR, LA, SR, XR, DR, multiphasic
  MRFG	Mutual Recognition Fascilitation Group (of the EEA; since 2005 CMDh)
  MRM	Multiple Reaction Monitoring (MS)
  MRP	Mutual Recognition Procedure (in the EEA)
  MRT	Mean of Residence Times (sloppy: Mean Residence Time)
  MS	Manuscript Mass Spectrometry
  M&S	Modeling and Simulation
  MSD	Multivariate Statistical Distance
  MSE	Mean Squared Error
  MS-MS	Tandem Mass Spectrometry
  MSWP	Modeling and Simulation Working Party (of the CHMP); merged 2022 with other working parties in the MWP
  MTD	Maximum Tolerated Dose (aka RP2D)
  MVR	Monitoring Visit Report
  MVUE	Minimum Variance Unbiased Estimator
  MWP	Methodology Working Party (of the CHMP)
  NWG	Nanomedicines Working Group (of the IPRP)
  m/z	Mass/charge ratio (MS)

• N                

  Term	Meaning
  n	nano (10–9 prefix of the SI)
  n	Number of values
  N	(Total) sample size (also n)
  n1	Sample size of the first stage of a TSD, sample size of the first group of a GSD
  n2	Sample size of the second stage of a TSD, sample size of the second group of a GSD
  NA	Not applicable
  NB	nota bene (note well)
  NAD	Nordic cooperation on alcohol and drugs
  NAFDAC	National Agency for Food and Drug Administration and Control (competent authority of Nigeria)
  NAP	Nationally Authorised Product
  NAPM	National Association of Pharmaceutical Manufacturers (US; merged in 2001 with the GPhA)
  NAT	N-acetyltransferase
  NBCD	Non-Biological Complex Drug
  NBE	New Biologic Entity
  NC	Not calculable
  NCA	National Competent Authority Noncompartmental Analysis (aka SHAM)
  NCE	New Chemical Entity (FDA term)
  NCS	Not clinically significant
  NDA	National Drug Authority (Uganda) New Drug Application (FDA term)
  NDDS	Novel Drug Delivery System
  NE	Not estimable
  NfG	Note for Guidance (of the EMEA)
  NHA	National Health Authority
  NHMRC	National Health and Medical Research Council (competent authority of Australia)
  NIH	National Institutes of Health (US)
  NIHS	National Institute for Health Sciences (Japan)
  NIMP	Non Investigational Medicinal Product (EU GMP term)
  NIS	Non-interventional Study
  NIST	National Institute of Standards and Technology (US)
  NLM	US National Library of Medicine
  NLME	Pharsight’s PopPK software
  NLMEM	Nonlinear Mixed-Effects Model
  NLT	Not less than
  NLYW	Nice looking young woman (© ElMaestro)
  NMA	National Medical Association
  NME	New Molecular Entity (FDA term)
  NMPA, CDE	National Medical Products Administration, Center for Drug Evaluation (formerly CFDA)
  NMR	Nuclear Magnetic Resonance
  NOAC	Novel Oral Anticoagulant
  NOAEL	No Observed Adverse Effect Level
  NOC	No Objection Certificate (CDSCO)
  NOL	No Objection Letter
  NOMESKO	Nordic Medico-Statistical Committee
  NONMEM	ICON Development Solutions’ PopPK software
  NPA	National Pharmaceutical Alliance (US; merged in 2000 to the GPhA)
  NPD	Nitrogen-Phosphorus Detector in GC
  NPRA	National Pharmaceutical Regulatory Agency (competent authority of Malaysia)
  NPV	Negative Predictive Value
  NQ	Not quantifiable
  NR	Normal Range Not reportable/reported
  NRC	National Research Council (US)
  n.s.	Not significant
  NSAID	Nonsteroidal anti-inflammatory drug
  NSB	Non specific binding
  Nt	Number of theoretical plates (chromatography)
  NtA	Notice to Applicants (EMA)
  NTA	Nanoparticle Tracking Analysis
  NTI(D)	Narrow Therapeutic Index (Drug)
  NTR	Narrow Therapeutic Range

• O                

  Term	Meaning
  OA	Open Access
  OAD	Once a day
  OD	Overdose
  ODT	Orodispersible Tablet
  OECD	Organisation for Economic Co-operation and Development
  OF	Objective Function
  OGD	Office of Generic Drugs (of the FDA’s CDER)
  OGDP	Office of Generic Drug Policy (of the FDA’s CDER)
  OIP	Orally Inhaled Product
  OL	Outlier
  OLS	Ordinary Least Squares
  ONDQA	Office of New Drug Quality Assessment (of the FDA’s CDER)
  OP	Original post(er)
  OPD	Once per day
  OPPI	Organisation of Pharmaceutical Producers of India
  OQ	Operational Qualification
  ORA	Office of Regulatory Affairs (of the FDA)
  ORCID	Open Researcher and Contributor ID
  OROS	Osmotic Release Oral System (MR)
  OS	Open Source Operating System
  OT	Off Topic
  OTC	Over-the-counter

• P                

  Term	Meaning
  p	(Number of) parameters pico (10–12 prefix of the SI)
  \(p(\textsf{x})\)	Probability of \(\textsf{x}\)
  PA	Precision and Accuracy (BMV)
  PAD	Pharmacological Active Dose Pulsed Amperometric Detection
  PAGANZ	Population Approach Group in Australia and New Zealand
  PAGE	Polyacrylamide Gel Electrophoresis Population Approach Group in Europe
  PAH	Polycyclic aromatic hydrocarbon
  PAHO	Pan American Health Organization
  PAMPA	Parallel Artificial Membrane Permeability Assay
  PAR	Public Assessment Report
  PAS	Prior Approval Supplement (FDA term)
  PAT	Process Analytical Technology
  \(\textsf{pAUC}_{\textsf{t}_{1}-\textsf{t}_{2}}\)	Partial AUC (within \(\left\{\textsf{t}_1,\textsf{t}_2\right\}\))
  PB	Protein binding
  PBE	Population Bioequivalence
  PBPK	Physiologically Based Pharmacokinetics
  p.c.	post cibum (after food)
  PCA	Percentage of the Common Area Principal Component Analysis
  PD	Pharmacodynamics
  PDCO	Paediatric Committee (of the EMA)
  PDE5	Phosphodiesterase type 5
  PDF	Portable Document Format Probability Density Function
  PDR	Physicians’ Desk Reference
  PDUFA	Prescription Drug User Fee Act (US)
  PE	Pharmaceutical Equivalence Point Estimate (value obtained by a Point Estimator)
  PEG	Polyethylene glycol
  PEI	Paul-Ehrlich-Institut (Federal Institute for Vaccines and Biological Medicinal Products, Germany)
  PFA	Principal Factor Analysis
  PFTBA	Perfluorotributylamine
  PGP	P-glycoprotein
  pH	Pons hydrogenii (power of hydrogen): negative decadic logarithm of the H+-activity \(=-\log_{10}(a_{\text{H}^+})\)
  Ph.Br.	Pharmacopoeia Britannica (British Pharmacopoeia)
  Ph.Eur.	Pharmacopoeia Europaea (European Pharmacopoeia)
  Ph.Int.	Pharmacopoeia Internationalis (International Pharmacopoeia)
  PhRMA	Pharmaceutical Research and Manufacturers of America
  PHX	Certara’s “Phoenix” software
  PI	Principal Investigator (GCP) Product Information
  PIC/S	Pharmaceutical Inspection Co-operation Scheme
  PIL	Patient Information Leaflet (EU)
  PIP	Paediatric Investigation Plan
  PIS	Patient Information Sheet
  PK	Pharmacokinetics
  pKa	Acid dissociation constant: negative decadic logarithm of the acid-ionization constant \(K_a\) \(=-\log_{10}(K_a)\)
  PKPD	PK-PD model
  PKWP	Pharmacokinetics Working Party (of the EMA’s CHMP); merged 2022 with other working parties in the MWP
  PL	Package Leaflet
  PM	Personal Message Personalised Medicine Poor metabolizer (also SM) Preventive maintenance
  PMA	Premarket Approval Prospective Meta-Analysis
  PMDA	Pharmaceuticals and Medical Devices Agency (competent authority of Japan)
  PMI	Prescription Medication Information (FDA term)
  PMID	PubMed identifier
  PO	per os (orally; also po)
  POM	Prescription-only Medicine
  PopPK	Population Pharmacokinetics
  PopPKPD	Population Pharmacokinetics-Pharmacodynamics
  POT-25	Peak Occupancy Time 25 (time interval where \(\textsf{C}\geq \textsf{75% C}_\textsf{max}\); aka t75%)
  POT-50	Peak Occupancy Time 50 (time interval where \(\textsf{C}\geq \textsf{50% C}_\textsf{max}\); aka HVD)
  PowerTOST	Power and sample size based on the TOST-procedure for BE studies (package for )
  p.p.	post prandium (after a meal)
  PP	Per Protocol
  PPI	Proton Pump Inhibitor
  PPV	Positive Predictive Value
  PPT	Protein Precipitation
  PQ	Performance Qualification
  PQM+	Promoting the Quality of Medicines Plus (collaboration of the USP and USAID)
  PQP	Prequalification of Medicines Programme (WHO)
  PQT	Prequalification Team (WHO)
  PQRI	Product Quality Research Institute
  PQTm	WHO Prequalification Team – Medicines
  PR	Pulse rate
  PRAC	Pharmacovigilance Risk Assessment Committee (of the EMA)
  PRIME	Priority Medicine
  PRISMA	Preferred Reporting Items for Systematic Reviews and Meta-Analyses
  PRNG	Pseudorandom number generator
  PSAP	Program Safety Analysis Plan
  PSD	Particle Size Distribution
  PSG	Product-Specific Guidance
  PSRtPH	Potential Serious Risk to Public Health (EEA term)
  PSUR	Periodic Safety Update Report (in the EEA)
  pt	Point
  PT	Preferred Term (MedDRA)
  PtC	Points to Consider (of the EMEA/EMA)
  %PTF	Percent Peak-Trough Fluctuation \(=100(\textsf{C}_\textsf{max,ss}-\textsf{C}_\textsf{min,ss})/\textsf{C}_\textsf{av,ss}\), where \(\textsf{C}_\textsf{av,ss}=\textsf{AUC}_{0-\textsf{τ}}/\textsf{τ}\)
  PTL	Product Team Leader (EMA)
  PubMed	Public MEDLINE
  PV	Pharmacovigilance
  PVAR	Preliminary Variation Assessment Report
  PVT	Performance Verification Testing
  ℞	Prescription (also Rx)

• Q                

  Term	Meaning
  Q	Quarter
  QA	Quality Assurance Quality Attribute
  Q&A	Questions and Answers
  QAU	Quality Assurance Unit
  QbD	Quality by Design
  QC	Quality Control
  Q.E.D.	quod erat demonstrandum (what was to be demonstrated, end of proof; also ∎ or □)
  QH	Hepatic blood flow
  QI, QIII	First, third quartile (25%, 75% percentile)
  QM(S)	Quality Management (System)
  QoL	Quality of life
  QP	Qualified Person (in the EU)
  QPPV	Qualified Person for Pharmacovigilance (in the EU)
  Q-Q	Quantile-Quantile
  QR	Renal blood flow
  QT	Interval defined by start of the Q wave to the end of the T wave
  QTcB	QT corrected for HR by Bazett’s formula
  QTcT	QT corrected for HR by Fridericia’s formula
  QTPP	Quality Target Product Profile
  QWG	Quality Working Group (of the IPRP)
  QWP	Quality Working Party (of the EMA’s CHMP)

• R                

  Term	Meaning
  R	Accumulation index Reference (product, treatment) in comparative BA
  \(R\)	Coefficient of correlation
  	A language and environment for statistical computing and graphics (OS implementation of S, licensed under the GPL)
  (R)	rectus (right) stereocenter according to the CIP
  \(R^2\)	Coefficient of determination
  \(R_{\text{adj}}^2\)	\(R^2\) adjusted for sample size (and number of estimated parameters)
  RA	Regulatory Authority
  RBC	Red blood cells
  RCA	Root Cause Analysis
  RCF	Relative Centrifugal Force (more common: × g)
  RCT	Randomized controlled (or clinical) trial
  R&D	Research and Development
  RDE	Remote Data Entry
  RD/OMP	Rare Disease & Orphan Medicinal Product
  %RE	Percent Relative Error, bias \(=100(\widehat{\textsf{x}}-\textsf{x})/\textsf{x}\), where \(\widehat{\textsf{x}}\) is the estimated and \(\textsf{x}\) the true value
  REML(E)	Restricted Maximum Likelihood (Estimator)
  REMS	Risk Evaluation Mitigation Strategies (FDA term)
  RFC	Request for Comments
  R·HCl	Hydrochloride of base R
  RHI	Regional Harmonisation Initiative
  RI	Refractive Index
  RIA	Radioimmunoassay
  RLD	Reference Listed Drug (FDA term)
  Rmax	Maximum Excretion Rate
  RMP	Reference Medicinal Product Risk Management Plan
  RMS	Reference Member State (in European MRP)
  ROA	Route of Administration
  ROC	Receiver Operating Characteristic
  RP	Reflection Paper Reversed Phase
  RP2D	Recommended Phase II Dose (aka MTD)
  rpm	Rotations per minute (only if the geometry is defined – like in dissolution apparatuses; uninformative in centrifugation, see RCF)
  RSABE	Reference-Scaled Average Bioequivalence
  RSD	Relative Standard Deviation (\(s_x/\overline{x}\), aka CV)
  RSS	Rich Site Summary
  RT	Retention time (aka tR) Risk Type Room temperature
  RTF	Rich Text Format
  RTFM	Read The Fucking Manual
  RTR	Refuse-to-Receive (in an ANDA)
  RTRT	Real-time Release Testing
  RWE	Real-world evidence
  RWD	Real-world data

• S                

  Term	Meaning
  \(s\)	Sample standard deviation (also SD)
  S	Programming language for statistics
  (S)	sinister (left) stereocenter according to the CIP
  \(s^2\)	Sample variance
  SAAM	Scientists Advancing Affordable Medicines (US)
  SAE	Serious Adverse Event
  SABE	Scaled Average Bioequivalence
  SAE	Serious Adverse Event
  SAEM	Stochastic Approximation Expectation Maximization
  SAP	Statistical Analysis Plan
  SAHPRA	South African Health Products Regulatory Agency (until 2017 MCC)
  SAR	Serious Adverse Reaction Statistical Analysis Report
  SAS	Statistical Analysis System
  SAT	Site Acceptance Test
  SAWP	Scientific Advice Working Party (of the EMA)
  SBC	Schwarz’ Bayesian Criterion (aka BIC)
  SBP	Systolic blood pressure
  SC	Subcutaneous (also sc)
  SCNR	Sorry, could not resist!
  SCOT	Support-Coated Open Tubular (capillary column in GC)
  SD	Single Dose Sample Standard Deviation (also \(s\)) Study Director (GLP)
  SDS	Sodium Dodecyl Sulfate (also SLS = Sodium Lauryl Sulfate)
  SDTM	Study Data Tabulation Model (of the CDISC)
  SE	Standard Error (also SEM, Standard Error of the Mean)
  SEB	Subsequent Entry Biologic
  SEC	Size Exclusion Chromatography
  SEDDS	Self-Emulsifying Drug Delivery System
  SEE	Study exit examination
  SEND	Standard for Exchange of Nonclinical Data (of the CDISC)
  S×F	Subject-by-Formulation (Interaction)
  SFC	Supercritical Fluid Chromatography
  SFDA	Saudi Food & Drug Authority (Saudia Arabia) State Food and Drug Administration (China; since 2013 CFDA)
  SFU	Safety follow-up
  SGF	Simulated Gastric Fluid
  SGML	Standard Generalized Markup Language
  SGOT	Serum glutamic oxaloacetic transaminase
  SGPT	Serum glutamic pyruvic transaminase
  SHA	Secure Hash Algorithm
  SHAM	Shape, Height, Area, Moments (aka NCA)
  SI	Système international d’unités (International System of Units)
  SIF	Simulated Intestinal Fluid
  SIL(IS)	Stable isotope labeled (internal standard)
  SIM	Single Ion Monitoring (MS)
  Sim’s	(Number of) simulations
  SIR	Single Ion Recording (MS)
  SL	Sublingual
  SLS	Sodium lauryl sulfate
  SM	Slow metabolizer (also PM) Small Molecule
  SMILES	Simplified Molecular-Input Line-Entry System
  SMO	Site Management Organisation
  SmPC	Summary of Product Characteristics (EEA term)
  S/N	Signal/noise ratio
  SOC	System Organ Class (MedDRA term)
  SODF	Solid Oral Dosage Form
  SOP	Standard Operating Procedure
  SPE	Solid Phase Extraction
  S-PLUS	Commercial implementation of S
  SPSS	Statistical Product and Service Solutions (formerly Statistical Package for the Social Sciences)
  SQL	Structured Query Language
  SR	Sustained Release MR product (also CR, LA, XR)
  SRM	Selected Reaction Monitoring (MS)
  SRS	Spontaneous Reporting System
  ss	Steady state
  SS	Semisolid (formulation) Sum of Squares (also SSQ, SSE) System Suitability
  SSR	Sample Size Reassessment (or Re-estimation)
  SSRI	Serotonin-specific re-uptake inhibitor
  SST	System Suitability Test
  STFW	Search The Fucking Web
  SUPAC	Scale-Up and Post-Approval Changes (FDA term)
  SUSAR	Suspected Unexpected Serious Adverse Reaction (EEA term)
  swissmedic	Swiss Agency for Therapeutic Products (competent authority of Switzerland)
  SWP	Safety Working Party (of the EMA’s CHMP)
  \(s_{\text{wR}}\)	Within-subjects standard deviation of the Reference product estimated in a replicate design
  \(s_{\text{wT}}\)	Within-subjects standard deviation of the Test product estimated in a fully replicated design

• T                

  Term	Meaning
  T	Test (product, treatment) in comparative BA
  t0	Elution time of void (chromatography)
  \(\textsf{t}^\ast\)	Length of infusion
  \(\textsf{t}_\boldsymbol{½}\)	Half life time \(=\frac{\log_e(2)}{\widehat{\lambda}_\text{z}}\)
  \(\textsf{t}_\textsf{75%}\)	Plateau Time (time interval where \(\textsf{C}\geq \textsf{75% C}_\textsf{max}\); aka POT-25)
  TAD	Time after dose (common notation in PopPK)
  \(\textsf{t}_\textsf{apical}\)	Average of times within POT-25
  TAW	Time Allowance Window
  TB	Tuberculosis
  t.b.d.	To be determined
  TBIL	Total bilirubin
  TBM	To-be-marketed (formulation)
  TCA	Trichloroacetic acid Tricycle antidepressant
  TCD	Thermal Conductivity Detector in GC
  TCOL	Total cholesterol
  TDDS	Transdermal Delivery System
  TDM	Therapeutic Drug Monitoring
  TDS	Transdermal System
  TE	Therapeutic Equivalence
  TEAE	Treatment-emergent adverse event
  TeX	Typesetting program
  TGA	Therapeutic Goods Administration (Australia)
  TGD	Therapeutic Products Directorate (of HC’s HPFB)
  TGPA	Taiwan Generic Pharmaceutical Association
  TFDA	Taiwan Food and Drug Administration
  TIC	Total Ion Current (MS)
  TID	ter in die (thrice a day)
  TIE	Type I Error
  TİTCK	Türkiye İlaç ve Tıbbi Cihaz Kurumu (Turkish Medicines and Medical Devices Agency)
  TK	Toxicokinetics
  \(\textsf{t}_\textsf{lag}\)	Lagtime
  \(\textsf{t}_\textsf{last}\)	Time point of the last measured concentration of the profile (also \(\textsf{t}_\textsf{z}\))
  \(\textsf{t}_\textsf{last (Common)}\)	Last time point where a subject’s concentrations after all treatments are quanti­fi­able
  TLC	Thin Layer Chromatography
  TLP	Top level post
  \(\textsf{t}_\textsf{max},\,\textsf{t}_\textsf{max,ss}\)	Time point of maximum concentration (single dose, steady state); observed in NCA, estimated by PK modeling
  TMF	Trial Master File
  \(\textsf{t}_\textsf{min,ss}\)	Time point of minimum concentration in steady state; observed in NCA, estimated by PK modeling
  TNR	True Negative Rate (Specificity)
  TPA	Therapeutic Products Act
  TOF	Time-of-Flight (MS)
  TOFU	Food made from coagulated soy milk Synonym for top-posting in e-mails and Internet forums
  TOST	Two One-Sided Tests
  TPP	Target Product Profile
  TPR	True Positive Rate (Sensitivity)
  tR	Retention time (aka RT)
  T/R	Test/Reference ratio (also GMR)
  TRIG	Triglycerides
  Troll	A being in Nordic folklore A person who posts deliberately offensive or provocative messages
  TRIG	Triglycerides
  TSD	(Adaptive) Two-Stage Design
  TSH	Thyroid-stimulating hormone
  TSV	Tab-Separated Values
  TTT	Two times \(\textsf{t}_\textsf{max}\)
  TTTP	Two-treatment, two-period (crossover)

• U                

  Term	Meaning
  U	Upper limit of the reference-scaled average BE acceptance range (ABEL) \(=e^{+0.76\,\cdot\, s_{\text{wR}}}\)
  UAC	Uric acid
  uc	Upper cap of expansion in ABEL (EMA and most other agencies at CVwR = 50%, HC at ≈ 57.382%)
  ug	Microgram (non-SI replacement for µg; acceptable on 7-bit text systems)
  UHPLC	Ultrahigh-Pressure Liquid Chromatography
  UIR	Unit Impulse Response
  UL	Upper total sample size limit in TSDs
  ULOQ	Upper Limit of Quantification
  UMR	Urinary metabolic ratio
  URI	Uniform Resource Indicator
  URL	Uniform Resource Locator
  URS	User Requirement Specifications
  USAID	United States Agency for International Development (eradicated in 2025 Trumpistan)
  USAN	United States Adopted Name
  USP	United States Pharmacopeia
  UTC	Coordinated Universal Time (in the UK GMT)
  UTF	Unicode Transformation Format
  UV	Ultraviolet

• V                

  Term	Meaning
  Varea	Apparent Volume of Distribution (aka Vβ)
  VAS	Visual analog scale
  VBA	(Microsoft’s) Visual Basic for Applications
  Vd	Volume of Distribution of the central compartment (also Vc, V1)
  VIF	Variance Inflation Factor
  VIS	Visible (light)
  Vm	Maximum elimination rate (Michaelis-Menten kinetics)
  VPC	Visual Predictive Check
  vs	versus (against, compared to)
  Vss	Apparent Volume of Distribution in steady state

• W                

  Term	Meaning
  w	Weight
  w0.5	Peak’s width at ½ of its height
  WBC	White blood cells
  WCOT	Wall-Coated Open Tubular (capillary column in GC)
  WHO	World Health Organization
  WHO-UMC	WHO-Uppsala Monitoring Centre
  WHOART	WHO Adverse Event Terminology
  WIPO	World Intellectual Property Organization
  WMA	World Medical Association
  WN	Wagner-Nelson (method of estimating absorption)
  WNL	Certara’s “WinNonlin” software
  WO	Wash-out (phase) in crossover designs
  WSS	Weighted Sum of Squares
  WTO	World Trade Organization

• X                

  Term	Meaning
  x	Independent variable
  \(\overline{\textsf{x}}\)	(Arithmetic) sample mean
  \(\widetilde{\textsf{x}}\)	Sample median
  \(\overline{\textsf{x}}_\textsf{geom}\)	Geometric sample mean (also GM)
  \(\overline{\textsf{x}}_\textsf{harm}\)	Harmonic sample mean
  (X)HTML	(Extensible) Hypertext Markup Language
  XML	Extensible Markup Language
  Xover, XO	Crossover (design)
  XR	Extended Release MR product (aka ER; also CR, LA, SR)
  XRD	X-Ray Diffraction

• Y                

  Term	Meaning
  y	Dependent variable Year (SI: a)
  YMHS	Young Male Healthy Subject
  YYYY[-MM][-DD]	ISO 8601 date format, where the months and days are optional; all values are zero-padded (MM: 01–12, DD: 01–31)

• Z                

  Term	Meaning
  z	Index denoting the last value of a profile (examples: \(\widehat{\lambda}_\textsf{z}\), \(\textsf{t}_\textsf{z}\))
  Z	Offset of the local time to UTC given as ±HH:mm or ±HHmm, where HH and mm have to be given with a leading zero if ≤ 9 The sign is mandatory, where Z for local times equal to UTC can be given as +00:00, while ±00:00 is acceptable according to since ISO 8601:2004(3.4.2), e.g., for WET it can be given as +00:00 or ±00:00 (but not −00:00), wheras for CET it must be given as +01:00, for IST as +05:30, and for EST as −05:00 If mm = 0 it can be dropped and only the HH part kept, e.g., for WET given as ±00, for CET as +01, and for EST as −05 If a local date and time is combined, the parts must be separated with the letter T to e.g., YYYY-MM-DDTHH:mm:ssZ (while widely used, separating the parts with a space is not allowed according to ISO 8601)
  ZL	Zentrallaboratorium Deutscher Apotheker (Central Laboratory of German Pharmacists)

• 123                

  Term	Meaning
  \(1-\beta\)	Power (rarely \(\pi\))
  2×2×2	2-treatment, 2-sequence, 2-period crossover design (also 2×2, TR|RT, 2,2,2)
  2×2×3	2-treatment, 2-sequence, 3-period full replicate designs (TRT|RTR, TRR|RTT)
  2×3×3	2-treatment, 3-sequence, 3-period partial replicate designs (TRR|RTR|RRT, TRR|RTR)
  2×2×4	2-treatment, 2-sequence, 4-period full replicate designs (TRTR|RTRT, TRRT|RTTR, TTRR|RRTT)
  2×4×2	2-treatment, 4-sequence, 2-period (Balaam’s) design (TR|RT|TT|RR)
  3×3×3	3-treatment, 3-sequence, 3-period (Latin Square) design (also 3×3, ABC|BCA|CAB)
  3×6×3	3-treatment, 6-sequence, 3-period (Williams’) design (ABC|ACB|BAC|BCA|CAB|CBA)
  3R	Reduction, Replacement, and Refinement
  4GL	Fourth-generation programming language
  666	Ἀριθμὸς τοῦ θηρίου

• αβγ                

  Term	Meaning
  \(\alpha\)	Probability of Type I Error (clinical studies: patient’s risk; laboratory tests: False Positive Rate) Fast hybrid rate constant in two-compartment PK
  \(\alpha_\text{adj}\)	Adjusted \(\alpha\) (multiplicity correction)
  \(\alpha_\text{emp}\)	Empiric \(\alpha\) (obtained in simulations)
  \(\beta\)	Probability of Type II Error (clinical studies: producer’s risk; laboratory tests: False Negative Rate) Slow hybrid rate constant in two-compartment PK
  \(\beta_\text{emp}\)	Empiric \(\beta\) (obtained in simulations)
  \(\gamma\)	Mass concentration (IUPAC)
  \(\it{\Delta}\)	(Clinically relevant) difference in comparative BA
  \(\delta\)	Margin of clinical relevance in Non-Inferiority/Superiority and Non-Superiority
  \(\delta_\text{a},\,\delta_\text{s}\)	Polli and McLean metrics
  \(\epsilon\)	Residual error
  \(\eta\)	Random effect in PopPK
  \(\theta\)	Subject’s parameter value in PopPK
  \(\theta_0\)	Expected ratio
  \(\theta_{1,2}\)	Lower (1) and upper (2) limit of the acceptance range
  \(\theta_\text{s}\)	Regulatory switching condition in RSABE (see also k)
  \(\widehat{\lambda}_\text{z}\)	Apparent (estimated) terminal rate constant (in guidelines sloppy Kel)
  μ	micro (10–6 prefix of the SI)
  \(\mu\)	Population mean
  \(\nu\)	Degrees of freedom (also df)
  \(\xi\)	Rescigno’s BE index
  \(\pi\)	Power \(=1-\beta\)
  \(\pi_\text{emp}\)	Empiric power (obtained in simulations \(=1-\beta_\text{emp}\))
  \(\Pi\)	Product
  \(\rho\)	Correlation Volumetric mass density (IUPAC)
  \(\rho,\,\rho_\text{m}\)	Polli and McLean metrics
  \(\sigma\)	Population standard deviation
  \(\sigma_0\)	Regulatory standardized variation
  \(\sigma^2\)	Population variance
  \(\Sigma\)	Sum
  \(\textsf{τ}\)	Dosing interval
  \(\psi\)	Chinchilli metric

• ∈√∫        

  Term	Meaning
  \(\in\)	Element of
  \(\notin\)	Not an element of
  \(\subset\)	(Proper) subset
  \(\subseteq\)	Subset (border elements included)
  \(\nsubseteq\)	Not a subset
  \(\cap\)	Intersection
  \(\cup\)	Union
  \(\propto\)	Proportional to
  \(\int\)	Integral
  \(\sqrt{}\)	Square root (aka radical sign, radix)
  \(\infty\)	Infinity
  \(\wedge\)	And
  \(\vee\)	Or
  \(\neg\)	Not
  \(\equiv\)	Identical
  \(\sim\)	Similar
  \(\approx\)	Approximately equal
  \(\neq\)	Not equal
  \(\leq\)	Less or equal than
  \(\geq\)	Greater or equal than
  \(\ll\)	Much less than
  \(\gg\)	Much greater than
  \(\mathbb{N}\)	Integer (number)
  \(\mathbb{R}\)	Real (number)
  \(\mathbb{R}^{+}\)	Positive real number
  \(\ldots\)	Ellipsis
  \(\small{\blacksquare}, \small{\square}\)	quod erat demonstrandum (what was to be demonstrated), end of proof