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Everything you always wanted to know (but were afraid to ask): Abbreviations, acronyms, jargon, and symbols seen in the BEBA-Forum.
Non-English terms are typeset in italics.
Term | Meaning |
---|---|
a |
|
AAA | Amino acid analysis |
AAPS | American Association of Pharmaceutical Scientists |
Ab | Antibody |
ABCM | Area below Cmin,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 (USFDA) |
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 |
|
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, 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 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) |
AIC | Akaike Information Criterion |
aka | also known as |
ALCOA | Attributable, legible, contemporaneous, original and accurate |
AMA | American Medical Association |
AMS | Accelerator Mass Spectrometry |
ANCOVA | Analysis of Covariance |
ANDA | Abbreviated New Drug Application (USFDA 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) |
ANSI | American National Standards Institute |
ANSM | Agence nationale de sécurité du médicament et des produits de santé (National Drug and Health Products Safety Agency, France; formerly AFSSAPS) |
ANVISA | Agência Nacional de Vigilância Sanitária (National Agency for Sanitary Monitoring, Brazil) |
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) |
APhA | American Pharmacists Association |
API |
|
AR | Acceptance Range |
ARE | Amount Remaining to be Excreted |
ARGOM | Australian Regulatory Guideline for OTC Medicines |
ARGPM | Australian Regulatory Guidelines for Prescription Medicines |
ASA | American Statistical Association |
ASAP | As soon as possible (read: As slow as possible) |
ASCII | American Standard Code for Information Interchange |
ASEAN | Association of Southeast Asian Nations |
ASMS | American Society for Mass Spectrometry |
AT | Ambient temperature |
ATC | Anatomical Therapeutic Chemical (Classification System by the WHO) |
ATMP | Advanced-Therapy Medicinal Product |
AUC |
|
AUCapical | Average of AUCs within POT |
AUCextrap | Extrapolated part of the AUC; commonly in percent \(100(AUC_{0-\infty}-AUC_{0-t})/AUC_{0-\infty}\) |
%AUCF | AUC above average concentration / AUCτ in percent |
AUCt | AUC from t = 0 to the time point of the last measured concentration (also AUC0–t, AUCtlast, AUCtz) |
AUCτ | AUC within one dosing interval in steady state (also AUC0–τ) |
AUC∞ | AUC from t = 0 to infinite time (also AUC0–∞) |
AUEC | Area Under the Effect Curve |
AUMC | Area Under the first Moment of the Curve \(\int t\cdot C(t){\mathrm{d} t}\) |
Term | Meaning |
---|---|
BA |
|
BAN | British Adopted Name |
BASG | Bundesamt für Sicherheit im Gesundheitswesen (Federal Office for Safety in Health Care, Austria) |
BBB | Blood–brain barrier |
BCS | Biopharmaceutics Classification System |
BDDCS | Biopharmaceutics Drug Disposition Classification System |
BE | Bioequivalence (technically there are no ‘BE studies’ – BE is the desired outcome of a comparative BA study) |
bear |
|
BE NOC | Bioequivalence No Objection Certificate (CDSCO term) |
BfArM | Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany) |
BIBD | Balanced Incomplete Block Design |
BIC | Bayesian Information Criterion (aka SBC) |
BID | bis in die (twice a day) |
BLA | Biologics License Application (USFDA 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 |
|
BSCV | Between-subjects CV (also CVB, CVinter) |
BsUFA | Biosimilar User Fee Act (US) |
BSWP | Biostatistics Working Party (of the EMA’s CHMP) |
BTIF | Bioequivalence Trial Information Form (WHO) |
BTW | By the way |
BW |
|
BWP | Biologics Working Party (of the EMA) |
BZD | Benzodiazepine |
Term | Meaning |
---|---|
C | (Measured, observed) concentration |
Ĉ | Estimated concentration |
C0 | Intercept in the log-linear estimation of λz |
ca. | circa (approximately) |
CA | Competent Authority |
Caco-2 | Human colon adenocarcinoma cell line |
CAP | Centrally Authorised Product (EMA) |
CAPA | Corrective and Preventive Action |
Capical | Average of concentrations within POT |
CAP | Centrally Authorised Product (in the EEA) |
CAS |
|
CAT | Committee for Advanced Therapies (of the EMA) |
Cav,ss | Average concentration in steady state (\(AUC_{0-\tau}/\tau\)) |
CC |
|
CD | Circular Dichroism |
CDD | Critical Dose Drug |
CDE | Center For Drug Evaluation (Taiwan) |
CDER | Center for Drug Evaluation and Research (of the USFDA) |
CDISC | Clinical Data Interoperability Standards Consortium |
CDS | Chromatography Data System |
CDSCO | Central Drugs Standard Control Organization (India) |
CE |
|
CEP | Clinical Endpoint |
CEST | Central European Summer Time (UTC+2) |
CET | Central European Time (UTC+1) |
CFDA | China Food & Drug Administration (formerly SFDA) |
CEX | Cation Exchange |
CFR | Code of Federal Regulations (US) |
cGMP | Current Good Manufacturing Practice﴾s﴿ |
CHMP | Committee for Medicinal Products for Human Use (of the EMA) |
CHO | Carbohydrate |
CI |
|
CIOMS | Council for International Organizations of Medical Sciences |
CL |
|
Clast | Last measured concentration of the profile |
Ĉlast | Estimated last concentration of the profile |
CL/ƒ | Apparent Clearance after extravascular administration |
CLIA | Clinical Laboratory Improvement Amendments |
Cmax | Maximum concentration |
CMC | Chemistry, Manufacturing, and Controls |
CMDh | Co-ordination group for Mutual recognition and Decentralised procedures – human (of the EEA; until 2005 MRFG) |
Cmin,ss | Minimum concentration in steady state (also Ctrough) |
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 |
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 (USFDA; replaced by the MedRA) |
COTS | Commercial off-the-shelf |
CP |
|
CPD | Citrate Phosphate Dextrose (AC) |
CPDA | Citrate Phosphate Dextrose Adenine (AC) |
CPMP | Committee for Proprietary Medicinal Products (EC) |
CQA | Critical Quality Attribute |
CR | Controlled Release (also ER/LA/MR/SR) |
CRA | Clinical Research Associate |
CRAN | Comprehensive R 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 |
CT | Clinical Trial |
Cτ | Concentration at intended dosing interval τ after a single dose |
Cτ,ss | Concentration at the end of the dosing interval τ in steady state |
CTA | Clinical Trial Application |
CTC | Common Toxicity Criteria |
CTCAE | Common Terminology Criteria for Adverse Events |
CTD |
|
CTM | Clinical Trial Manager |
CTR﴾I﴿ | Clinical Trial Registry (India) |
Ctrough |
|
CV |
|
CVG | Calibration and Validation Group |
CVinter | Between-subjects Coefficient of Variation (aka CVB, BSCV) |
CVintra | Within-subjects CV (aka CVW, ISCV) |
CVwR | Within-subjects CV of R estimated in a replicate design |
CVwT | Within-subjects CV of T estimated in a fully replicated design |
CYP | Cytochrome Pigment |
Term | Meaning |
---|---|
d | Day |
d | dextro enantiomer |
D | Dose |
DAD | Diode Array Detector |
DAR | Drug-antibody ratio |
DB | Database |
DBE | Division of Bioequivalence (USFDA/OGD) |
DBS | Dried Blood Spot |
DCD | Drug Control Division (Thailand) |
DCGI | Drug Controller General of India |
DCP | Decentralised Procedure (in the EEA) |
DCR | Division of Clinical Review (USFDA/OGD) |
DCS | Developability Classification System |
DDD | Defined daily dose (WHO term) |
DDI | Drug-Drug Interaction |
DDT | Drug Development Tool |
DE | Dissolution Efficiency |
DES | Drug-eluting stent |
DESI | Drug efficacy study implementation |
df | Degree(s) of freedom (also ν) |
DGDA | Directorate General of Drug Administration (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) |
DKMA | Danish Medicines Agency (since 2012 DHMA) |
DL | 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 |
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 |
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 |
Term | Meaning |
---|---|
EA | Ethyl acetate (aka EtOAc) |
EACPT | European Association for Clinical Pharmacology and Therapeutics |
EBE | European Biopharmaceutical Enterprises |
EBF | European Bioanalysis Forum |
EBG | European Biosimilars Group (of the EGA) |
EBM | Evidence-based medicine |
EC |
|
EC50 | Median Effective Concentration |
ECD |
|
ECG | Electrocardiography, Electrocardiogram |
eCTD | Electronic Common Technical Document |
ED50 | Median Effective Dose |
EDA |
|
EDC﴾S﴿ | Electronic Data Capture (System) |
EDL | Estimate of the Detection Limit (USEPA) |
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 |
EEU | Eurasian Economic Union (officially EAEU) |
EFPIA | European Federation of Pharmaceutical Industries and Associations |
e.g. | exempli gratia (for example) |
EGA | European Generic Medicines Association (since 2016: ‘Medicines for Europe’) |
EI | Electron Impact Ionization (MS) |
EIR | Establishment Inspection Report (USFDA) |
ELISA | Enzyme Linked Immunosorbent Assay |
ELS | Evaporative Light Scattering |
EM |
|
EMA | European Medicines Agency (formerly EMEA) |
Emax | Maximum Effect |
EMEA | European Agency for the Evaluation of Medicinal Products (since 2005: EMA) |
EMG | Exponentially Modified Gaussian |
EMIT | Enzyme Multiplied Immunoassay Technique |
EOD | End of discussion |
EORI | Economic Operators Registration and Identification number (EU) |
EPA | Environmental Protection Agency (US) |
EPAR | European Public Assessment Report |
EPO | Erythropoietin |
ER | Extended Release (aka XR; also CR/LA/MR/SR) |
ES | Eligible subject |
ESI | Electrospray Ionization (MS) |
ESV | End of Study Visit |
et al. | et alii (and others) |
ETASU | Elements to Assure Safe Use (USFDA term) |
EtOAc | Ethyl acetate (aka EA) |
EtOH | Ethanol |
EU | European Union (formerly EC) |
EUCROF | European CROs 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) |
EWP | Efficacy Working Party (of the EMA) |
EX | Excitation wavelength (FL) |
Term | Meaning |
---|---|
ƒ |
|
ƒ1 | Difference factor (comparing dissolution profiles) |
ƒ2 | Similarity factor (comparing dissolution profiles) |
F | ƒ given in percent |
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 | Food and Drug Administration (US) |
FDASIA | Food and Drug Administration Safety and Innovation Act (US) |
FDC | Fixed-Dose Combination |
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 |
FIM | First-In-Man (also FIH – First in Human) |
FIP | Fédération internationale pharmaceutique (International Pharmaceutical Federation) |
FL﴾D﴿ | Fluorescence (Detection) |
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) |
FT | Freeze/thaw (BMV) |
FTIR | Fourier Transform Infrared Spectroscopy |
FTP | File Transfer Protocol |
FUM | Follow-up Measures |
FWER | Familywise (Type I) Error Rate |
Term | Meaning |
---|---|
g | Standard acceleration due to gravity at the Earth’s surface (SI: 9.80665 m/s²) |
GaBI | Generics and Biosimilars Initiative |
GBC | Global Bioanalysis Consortium |
GBHI | Global Bioequivalence Harmonization Initiative |
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) |
GFR | Glomerular filtration rate |
GIT | 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 |
GPhA | Generic Pharmaceutical Association (US) |
GPL | General Public License |
GSD | Group-Sequential Design |
GUI | Graphical User Interface |
GVP | Good Pharmacovigilance Practice﴾s﴿ |
Term | Meaning |
---|---|
h | Hour (also hr) |
H0 | Null Hypothesis |
Ha | Alternative Hypothesis (also H1) |
HA |
|
HAS | Health Sciences Authority (Singapore) |
Hb | H﴾a﴿emoglobin (also Hgb) |
HC | Health Canada |
HCP | Healthcare Professional |
HETP | Height Equivalent of Theoretical Plate (in Chromatography) |
HILIC | Hydrophilic Interaction Liquid Chromatography |
HMA | Heads of Medicines Agencies (of the EEA) |
HMPC | Committee on Herbal Medicinal Products (of the EMA) |
hν | Light |
HPFB | Health Products and Food Branch (of HC) |
HPLC | High Performance Liquid Chromatography |
HPTLC | High Performance Thin Layer Chromatography |
HQC | High QC (sample) |
HR | Heart rate |
HSA | Health Sciences Authority (Singapore) |
HTML | Hypertext Markup Language |
HTTP | Hypertext Transfer Protocol |
HV | Human Volunteer |
HVD |
|
HVDP | Highly Variable Drug Product |
Term | Meaning |
---|---|
IA |
|
IB | Investigator’s Brochure |
IBD | Incomplete Block Design |
IBE | Individual Bioequivalence |
IBS | International Biometric Society |
IBW | Ideal Body Weight |
IC |
|
ICBM | Intercontinental Ballistic Missile |
ICD |
|
ICF | Informed Consent Form |
ICH | International Council for Harmonisation (until October 2015 International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use) |
ICMR | Indian Council of Medical Research |
ICP/MS | Inductively Coupled Plasma Mass Spectrometry |
ICSR | Individual Case Safety Report |
IDE | Integrated Development Environment |
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 Distributions |
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 GMP term) |
IND | Investigational New Drug (USFDA term) |
INN | International Nonproprietary Name |
INVIMA | Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute of Food and Drug Monitoring, Colombia) |
IP |
|
IPAC-RS | International Pharmaceutical Aerosol Consortium on Regulation & Science |
IPD | Individual Patient Data |
IPR | Intellectual Property Rights |
IQ | Installation Qualification |
IQR | Interquartile Range |
IR |
|
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 |
ISR | Incurred Sample Reproducibility (also … Re-analysis) |
ISSN | International Standard Serial Number |
ISV | Internal Standard Variation |
ISTQB | International Software Testing Qualifications Board |
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 |
IWRS | Interactive Web Response System |
Term | Meaning |
---|---|
JFDA | Jordan Food and Drug Administration |
Term | Meaning |
---|---|
k | Regulatory constant in ABEL (see also θs) |
k’ | Capacity factor in chromatography \((t_R-t_0)/t_0\) |
k0 | Infusion rate constant (aka kin) |
ka | Absorption rate constant (aka k01) |
KASA | Knowledge-aided Assessment & Structured Application |
kel | Elimination rate constant (aka k10) |
kxy | Between compartments rate constant (where x, y ≠ 0) |
KFDA | Korea Food & Drug Administration |
KISS | Keep it simple, stupid |
Km | Michaelis-Menten constant |
KR | Kenward-Roger approximation of degrees of freedom |
Term | Meaning |
---|---|
l | levo enantiomer |
L | Lower limit of the reference-scaled average BE acceptance range (ABEL) \(L=e^{-0.760\cdot s_{wR}}\) |
LA | Long Acting (Modified Release product) |
﴾L﴿ADME | (Liberation) Absorption, Distribution, Metabolism, Excretion |
LAR | Legally acceptable representative |
LaTeX | Document preparation system |
LBA | Ligand Binding Assay |
LC | Liquid Chromatography |
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 |
LOC | Lines of Code |
LOCF | Last Observation Carried Forward |
LOD | Limit of Detection (also DL) |
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 |
|
LS | Least Squares |
LSM | Least Squares Mean (aka Adjusted Mean) |
Term | Meaning |
---|---|
m | milli (10–3 prefix for the SI) |
MA | Marketing Authorisation (in the EEA) |
MAA | Marketing Authorisation Application (in the EEA) |
MAD |
|
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 (USFDA/CDER) |
MAR | Missing at random |
MAT | Mean Absorption Time |
MB | Management Board |
MCAR | Missing completely at random |
MCC | Medicines Control Council (since 2017 SAHPRA) |
MCMC | Markov Chain Monte Carlo |
MCP | Multiple Comparison Procedure |
MD |
|
MD5 | Message-digest 5 |
MDC | Minimum Detectable Concentration |
MDI | Metered Dose Inhaler |
MDL |
|
MDR | Multi-drug resistance |
MDT |
|
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) |
MEM | Mixed Effects Model |
MENA | Middle East and North Africa |
MeOH | Methanol |
MeSH | Medical Subject Headings |
MF | Matrix Factor |
MHLW | Ministry of Health, Labour and Welfare (Japan) |
MHRA | Medicines and Healthcare Products Regulatory Agency (UK) |
MIC | Minimum Inhibitory Concentration |
MIDD | Model-informed Drug Development |
MIR | Mean of individual subject ratios |
ML﴾E﴿ | Maximum Likelihood (Estimator) |
M-M | Michaelis-Menten kinetics |
MNAR | Missing not at random |
MoH | Ministry of Health |
MoM | Method of Moments |
MP | Mobile Phase |
MPA | Medicinal Products Act |
MPH | Metylphenidate |
MQC | Medium QC (sample) |
MR |
|
MRM | Multiple Reaction Monitoring (MS) |
MRP | Mutual Recognition Procedure (in the EEA) |
MRT | Mean of Residence Times (sloppy: Mean Residence Time) |
MS |
|
M&S | Modeling and Simulation |
MSD | Multivariate Statistical Distance |
MSE | Mean Squared Error |
MS-MS | Tandem Mass Spectrometry |
MTD | Maximum Tolerated Dose (aka RP2D) |
MVR | Monitoring Visit Report |
MVUE | Minimum Variance Unbiased Estimator |
m/z | Mass/charge ratio (MS) |
Term | Meaning |
---|---|
n |
|
N | Sample size (also n) |
n1 | Sample size in the first stage of a TSD |
NA | Not applicable |
NB | nota bene (note well) |
NAD | Nordic cooperation on alcohol and drugs |
NAP | Nationally Authorised Product |
NAT | N-acetyltransferase |
NBCD | Non-Biological Complex Drug |
NBE | New Biologic Entity |
NCA |
|
NCE | New Chemical Entity (USFDA term) |
NCS | Not clinically significant |
NDA |
|
NDDS | Novel Drug Delivery System |
NfG | Note for Guidance (of the EMEA/EMA) |
NHA | National Health Authority |
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 |
NMA | National Medical Association |
NME | New Molecular Entity (USFDA 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 |
NOL | No Objection Letter |
NOMESKO | Nordic Medico-Statistical Committee |
NONMEM | ICON Development Solutions’ PopPK software |
NPD | Nitrogen-Phosphorus Detector |
NPV | Negative Predictive Value |
NR | Normal Range |
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 |
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 USFDA’s CDER) |
OIP | Orally Inhaled Product |
OL | Outlier |
OLS | Ordinary Least Squares |
ONDQA | Office of New Drug Quality Assessment (of USFDA’s CDER) |
OP | Original post﴾er﴿ |
OPPI | Organisation of Pharmaceutical Producers of India |
OQ | Operational Qualification |
ORA | Office of Regulatory Affairs (of USFDA) |
ORCID | Open Researcher and Contributor ID |
OROS | Osmotic Release Oral System |
OS | Operating System |
OT | Off Topic |
OTC | Over-the-counter |
Term | Meaning |
---|---|
p |
|
p | Probability |
PA | Precision and Accuracy (BMV) |
PAD |
|
PAGANZ | Population Approach Group in Australia and New Zealand |
PAGE |
|
PAH | Polycyclic aromatic hydrocarbon |
PAHO | Pan American Health Organization |
PAMPA | Parallel Artificial Membrane Permeability Assay |
PAR | Public Assessment Report |
PAS | Prior Approval Supplement (USFDA term) |
PAT | Process Analytical Technology |
pAUCt1–t2 | Partial AUC within {t1, t2} |
PB | Protein binding |
PBE | Population Bioequivalence |
PBPK | Physiologically Based Pharmacokinetics |
p.c. | post cibum (after food) |
PCA |
|
PD | Pharmacodynamics |
PDCO | Paediatric Committee (of the EMA) |
Portable Document Format | |
PDR | Physicians’ Desk Reference |
PDUFA | Prescription Drug User Fee Act (US) |
PE | Point Estimate (numeric value of 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 |
PhRMA | Pharmaceutical Research and Manufacturers of America |
PHX | Certara’s “Phoenix” software |
PI |
|
PIC/S | Pharmaceutical Inspection Co-operation Scheme |
PIL | Patient Information Leaflet (EU) |
PIP | Paediatric Investigation Plan |
PIS | Patient Information Sheet |
PK | Pharmacokinetics |
PKWP | Pharmacokinetics Working Party (of the EMA’s CHMP) |
PL | Package Leaflet |
PM |
|
PMA |
|
PMDA | Pharmaceuticals and Medical Devices Agency (Japan) |
PMI | Prescription Medication Information (USFDA term) |
PMID | PubMed identifier |
PO | per os (orally; also po) |
POM | Prescription-only Medicine |
PopPK | Population Pharmacokinetics |
POT-25 | Peak Occupancy Time 25 (time interval where C ≥75% of Cmax; aka t75%) |
POT-50 | Peak Occupancy Time 50 (time interval where C ≥50% of Cmax; aka HVD) |
PowerTOST | Power and sample size based on TOST procedure for BE studies (package for R) |
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 (collaboration of the USP and USAID) |
PQP | Prequalification of Medicines Programme (WHO) |
PQRI | Product Quality Research Institute |
PQTm | WHO Prequalification Team – Medicines |
PRAC | Pharmacovigilance Risk Assessment Committee (of the EMA) |
PRIME | Priority Medicine |
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 |
PtC | Points to Consider (of the EMEA/EMA) |
%PTF | Peak-Trough Fluctuation \(100(C_{max,ss}-C_{min,ss})/C_{av,ss}\) where \(C_{av,ss}=AUC_{0-\tau}/\tau\) |
PTL | Product Team Leader (EMA) |
PubMed | Public MEDLINE |
PV | Pharmacovigilance |
PVAR | Preliminary Variation Assessment Report |
PVT | Performance Verification Testing |
Term | Meaning |
---|---|
Q | Quarter |
QA |
|
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 ∎) |
QH | Hepatic blood flow |
QM﴾S﴿ | Quality Management (System) |
QP | Qualified Person (in the EU) |
QPPV | Qualified Person for Pharmacovigilance (in the EU) |
Q-Q | Quantile-Quantile |
QR | Renal blood flow |
QTPP | Quality Target Product Profile |
QWP | Quality Working Party (of the EMA’s CHMP) |
Term | Meaning |
---|---|
R |
|
R² | Coefficient of correlation |
R²adj | Coefficient of correlation, adjusted for sample size |
RA | Regulatory Authority |
RCA | Root Cause Analysis |
RCF | Relative Centrifugal Force (also ×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 |
REML﴾E﴿ | Restricted Maximum Likelihood (Estimator) |
REMS | Risk Evaluation Mitigation Strategies (USFDA term) |
RFC | Request for Comments |
RI | Refractive Index |
RIA | Radioimmunoassay |
RLD | Reference Listed Drug (USFDA term) |
Rmax | Maximum Excretion Rate |
RMP |
|
RMS | Reference Member State (in European MRP) |
ROA | Route of Administration |
RP |
|
RP2D | Recommended Phase II Dose (aka MTD) |
rpm | Revolutions per minute |
RSABE | Reference-Scaled Average Bioequivalence |
RSD | Relative Standard Deviation (SD/x, aka CV) |
RSS | Rich Site Summary |
RT |
|
RTF | Rich Text Format |
RTFM | Read The Fucking Manual |
RTR | Refuse-to-Receive (in USFDA ANDA) |
RTRT | Real-time Release Testing |
RWD | Real-world data |
℞ | Prescription (also Rx, Rx) |
Term | Meaning |
---|---|
s | Sample standard deviation (also SD) |
s² | Sample variance |
SAD | Single Ascending Dose |
SAE | Serious Adverse Event |
SAEM | Stochastic Approximation Expectation Maximization |
SAP | Statistical Analysis Plan |
SAHPRA | South African Health Products Regulatory Agency (formerly MCC) |
SAR |
|
SAS | Statistical Analysis System |
SAT | Site Acceptance Test |
SAWP | Scientific Advice Working Party (of the EMA) |
SBC | Schwarz’ Bayesian Criterion (aka BIC) |
SC | Subcutaneous (also sc) |
SCNR | Sorry, could not resist! |
SCOT | Support-Coated Open Tubular (capillary column) |
SD |
|
SDS | Sodium Dodecyl 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 |
SEND | Standard for Exchange of Nonclinical Data (of the CDISC) |
S×F | Subject-by-Formulation (Interaction) |
SFC | Supercritical Fluid Chromatography |
SFDA |
|
SGF | Simulated Gastric Fluid |
SGML | Standard Generalized Markup Language |
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 |
|
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 |
SPME | Solid Phase Microextraction |
SPSS | Statistical Product and Service Solutions (formerly Statistical Package for the Social Sciences) |
SR | Sustained Release (also CR/ER/LA/MR) |
SRM | Selected Reaction Monitoring (MS) |
ss | Steady state |
SS |
|
SSR | Sample Size Reassessment (or Re-estimation) |
SSRI | Serotonin-specific re-uptake inhibitor |
SS﴾T﴿ | System Suitability (Test) |
STFW | Search The Fucking Web |
SUPAC | Scale-Up and Post-Approval Changes (USFDA term) |
SUSAR | Suspected Unexpected Serious Adverse Reaction (EEA term) |
SWP | Safety Working Party (of the EMA’s CHMP) |
swR | Within-subjects SD of R estimated in a replicate design |
swT | Within-subjects SD of T estimated in a fully replicated design |
Term | Meaning |
---|---|
T | Test (product) in comparative BA) |
t0 | Elution time of void (chromatography) |
t½ | Half life time |
t75% | Plateau Time (time interval where C ≥75% of Cmax; aka POT-25) |
TAD | Time after dose (common notation in PopPK) |
tapical | Average of times within POT |
TAW | Time Allowance Window |
TB | Tuberculosis |
t.b.d. | To be determined |
TBM | To-be-marketed (formulation) |
TCA |
|
TCD | Thermal Conductivity Detector |
TDDS | Transdermal Delivery System |
TDM | Therapeutic Drug Monitoring |
TDS | Transdermal System |
TEAE | Treatment-emergent adverse event |
TGA | Therapeutic Goods Administration (Australia) |
TGD | Therapeutic Products Directorate (of Canada’s HPFB) |
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 |
tlag | Lagtime |
tlast | Time point of the last measured concentration of the profile (also tz) |
tlast (Common) | Last time point where a subject’s concentrations after all treatments are quantifiable |
TLP | Top level post |
tmax | Time point of maximum concentration |
TMF | Trial Master File |
tmin | Time point of minimum concentration |
TNR | True Negative Rate (Specificity) |
TPA | Therapeutic Products Act |
TOF | Time-of-Flight (MS) |
TOFU |
|
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) |
TSI | Thermospray Ionization (MS) |
TSD | Two-Stage Design |
TSV | Tab-Separated Values |
TTT | Two times tmax |
TTTP | Two-treatment, two-period (crossover) |
Term | Meaning |
---|---|
U | Upper limit of the reference-scaled average BE acceptance range (ABEL) \(U=e^{+0.760\cdot s_{wR}}\) |
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 |
USAN | United States Adopted Name |
USP | United States Pharmacopeia |
UTC | Coordinated Universal Time (formerly GMT) |
UTF | Unicode Transformation Format |
UV | Ultraviolet |
Term | Meaning |
---|---|
Varea | Apparent Volume of Distribution (aka Vβ) |
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 |
Term | Meaning |
---|---|
w | Weight |
w0.5 | Peak’s width at ½ of its height |
WCOT | Wall-Coated Open Tubular (capillary column) |
WHO | World Health Organization |
WHO-UMC | WHO-Uppsala Monitoring Centre |
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 |
Term | Meaning |
---|---|
x | Sample mean |
x̃ | Sample median |
xgeo | Geometric sample mean (also GM) |
xharm | Harmonic sample mean |
XHTML | Extensible Hypertext Markup Language |
XML | Extensible Markup Language |
Xover, XO | Crossover (design) |
XR | Extended Release (aka ER or CR/LA/MR/SR) |
XRD | X-Ray Diffraction |
Term | Meaning |
---|---|
y | Year (SI: a) |
YMHS | Young Male Healthy Subject |
Term | Meaning |
---|---|
z | Index denoting the last value (examples: λz, tz) |
Term | Meaning |
---|---|
1–β | Power (rarely π) |
2×2×2 | Two-treatment, two-sequence, two-period crossover design (also 2×2, TR|RT, AB|BA, 2,2,2) |
2×2×3 | Two-treatment, two-sequence, three-period full replicate designs (TRT|RTR, TRR|RTT) |
2×3×3 | Two-treatment, three-sequence, three-period partial replicate designs (TRR|RTR|RRT, TRR|RTR) |
2×2×4 | Two-treatment, two-sequence, four-period full replicate designs (TRTR|RTRT, TRRT|RTTR, TTRR|RRTT) |
2×4×2 | Two-treatment, four-sequence, two-period Balaam’s design (TR|RT|TT|RR) |
3×3×3 | Three-treatment, three-sequence, three-period Latin square design (also 3×3, ABC|BCA|CAB) |
3×6×3 | Three-treatment, six-sequence, three-period Williams’ design (ABC|ACB|BAC|BCA|CAB|CBA) |
3R | Reduction, Replacement, and Refinement |
666 | Ἀριθμὸς τοῦ θηρίου |
Term | Meaning |
---|---|
α |
|
αadj | Adjusted α (multiplicity correction) |
αemp | Empiric α obtained in simulations |
β |
|
βemp | Empiric β obtained in simulations |
γ | Mass concentration (IUPAC) |
Δ | Difference |
δa, δs | Polli and McLean metrics |
ε | Residual error |
η | Random effect in PopPK |
θ | Subject’s parameter value in PopPK |
θ0 | Expected ratio |
θ1,2 | Lower (1) and upper (2) limit of the acceptance range |
θs | Regulatory switching condition in RSABE (see also k) |
λz | Apparent (estimated) terminal rate constant |
μ |
|
ν | Degrees of freedom (also df) |
ξ | Rescigno’s BE index |
π | Power (1 – β) |
ρ |
|
ρ, ρm | Polli and McLean metrics |
σ | Population standard deviation |
σ0 | Regulatory standardized variation |
σ² | Population variance |
τ | Dosing interval |
ψ | Chinchilli metric |
Term | Meaning |
---|---|
∈ | Element of |
∉ | Not an element of |
⊂ | (Proper) subset |
⊆ | Subset (border elements included) |
⊄ | Not a subset |
∩ | Intersection |
∪ | Union |
∝ | Proportional to |
∏ | Product |
∑ | Sum |
∫ | Integral |
√ | Square root (aka radical sign, radix) |
∞ | Infinity |
∧ | And |
∨ | Or |
¬ | Not |
≡ | Identical |
∼ | Similar |
≈ | Approximately equal |
≠ | Not equal |
≤ | Less or equal than |
≥ | Greater or equal than |
≪ | Much less than |
≫ | Much greater than |
ℕ | Integer (number) |
ℝ | Real (number) |
… | Ellipsis |
∎ | quod erat demonstrandum (what was to be demonstrated), end of proof |
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Ing. Helmut Schütz
Established 2004-07-30 | last update 2019-11-27 | document date 2013-12-12 | modified 2024-08-21