Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
Sample Size Estimation in Bioequivalence 💯☑️ 📌 Evaluation	Surveys	Helmut	2020-05-20 22:39	1	2020-06-03 12:36	11,870
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		117,078
Semireplicated + REML in R Semireplicated + REML in R Semireplicated + REML in R Avoid partial replicate designs, pleeeze! Avoid partial replicate designs, pleeeze! Braveheart! Who can help? Who can help? Update II Update III Final update today Medium rare. took just 52 hrs to do it :-) Will take much more hours still… Negative determinant Are we loosers? "we"? Loosers? Misunderstanding? Braveheart! Braveheart! Braveheart! Braveheart! We were all blind (except Detlew) It is the opposite way around for me Desultory thoughts FDA RSABE is ISC FDA RSABE is ISC Desultory thoughts Desultory thoughts Phoenix - which template? FDA RSABE Project template_ v1.4.phxproj "By popular demand": likelihood And by the way.... And by the way.... Not understood	R for BE/BA	ElMaestro	2020-07-10 13:19	34	2020-08-03 22:55	4,213
An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. An example of IS response. Need your helps. Placement of CC An example of IS response. An example of IS response. Placement of CC Placement of CC Duplicate LLOQ and ULOQ Duplicate LLOQ and ULOQ An example of IS response. Need your helps. An example of IS response. Need your helps. Trend analysis as per recent USFDA guideline Only for QCs; encouraged ≠ required Only for QCs; encouraged ≠ required Only for QCs; encouraged ≠ required	Bioanalytics	Shuanghe	2020-05-26 12:56	17	2020-08-03 13:56	3,293
Difference between BABE study and clinical trials Difference between BABE study and clinical trials BABE ∈ Phase I Difference between BABE study and clinical trials Difference between BABE study and clinical trials	Design Issues	VijithRoy	2020-07-30 15:15	4	2020-07-31 13:52	218
Pre-clinical PK/PD Parameters Pre-clinical PK/PD Parameters MIC: in vitro… Pre-clinical PK/PD Parameters	PK / PD	VijithRoy	2020-07-22 07:34	3	2020-07-31 08:18	231
Glucose Clamp Study Glucose Clamp Study Glucose Clamp Study Glucose Clamp Study Glucose Clamp Study Good luck :-) Good luck :-) Good luck :-) Good luck :-) Good luck :-) Good luck :-) Good luck :-)	PK / PD	VijithRoy	2020-07-21 04:25	11	2020-07-31 07:48	666
long half-life and large variability long half-life and large variability long half-life and large variability long half-life and large variability	Regulatives / Guidelines	martin	2020-07-29 16:57	3	2020-07-30 08:17	162
The grandiose shocker of 2020 The most obscure post ever Here goes Yeah but, no but, yeah but… Yeah but, no but, yeah but… Here goes The grandiose shocker of 2020 The grandiose shocker of 2020	General Statistics	ElMaestro	2020-07-22 13:17	7	2020-07-29 21:11	607
updates of installation bear with macOS (Mojave) upgrade R with macOS (Mojave) an old itch when running RGtk2 (GUI) with macOS upgrade/re-install cairoDevice package from source (macOS) updates of installation bear with macOS (Mojave) bear with Catalina OS Installing R v4.0.0 & bear on Catalina (macOS 10.15.3) updates of installing bear/R v4.0.0 with macOS (Catalina) tricks of R v4.0.0 tricks of R v4.0.0 tricks of R v4.0.0 tricks of R v4.0.0 errors of bear in R v4.0.0 errors of bear in R v4.0.0 speed? OT: What a relief :-) OT: What a relief :-) speed? speed? speed? speed? Xeon CPU Xeon (workstation, server) ↔ Core iX (desktop) updates of installation bear with macOS (Mojave) errors of installation bear with Catalina errors of installation bear with Catalina errors of installation bear with Catalina errors of installation bear with Catalina bear v2.8.8 pre-release built under R v4.0.0 for macOS still having problems w/ bear v2.8.8 for R v4.0.0 for macOS still having problems w/ bear v2.8.8 for R v4.0.0 for macOS still having problems w/ bear v2.8.8 for R v4.0.0 for macOS still having problems w/ bear v2.8.8 for R v4.0.0 for macOS utils::install.packages() depend = NA means ... install.package() for the source packages install.package() for the source packages desription Suggests section errors of installation bear on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows errors of installation bear (R v4.0.0) on Windows Accidentally perfect? Accidentally perfect?	R for BE/BA	yjlee168	2019-07-08 10:15	47	2020-07-28 18:58	15,590
Reanalysis for Pharmacokinetic Reason Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind PK assessors variability Sometimes PK assessors ≈ scientists PK assessors variability Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Positive pre-dose Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Reanalysis for PK Reason: Gone with the Wind Sightly OT (for once) Reanalysis for Pharmacokinetic Reason	Bioanalytics	Obinoscopy	2020-07-16 14:30	19	2020-07-27 23:47	1,754
Statistics Refresher Statistics Refresher	Bioanalytics	Helmut	2004-12-04 19:52	1	2020-07-27 23:37	11,107
Subject non compliance Subject non compliance (or product failure?) Subject non compliance (or product failure?) Bad science (statistics is taboo) unexpected behavior for test product Subject-by-Formulation interaction? Subject-by-Formulation interaction?	Study Assessment	Loky do	2020-07-15 12:57	6	2020-07-26 11:30	648
New Art. 31 referral: suspected data manipulation again New Art. 31 referral: suspected data manipulation again Referral concluded 😡	GxP / QC / QA	Ohlbe	2020-02-28 14:23	3	2020-07-24 18:00	1,540
[email protected]: COVID-19 ☣️ [email protected]: COVID-19 ☣️ [email protected]: COVID-19 ☣️ [email protected]: COVID-19 ☣️ [email protected]: COVID-19 ☣️ BABE 101 (lenghty and spiced with PK) Thank you Welcome	Software	Helmut	2020-04-20 14:15	7	2020-07-24 14:33	4,291