Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		142,988
Two Stage Desing: ANOVA Potvin et al: effects in stage 2 Potvin et al: effects in stage 2 Forget simulation-based TSDs for 2×2×2 in Europe TSD statistical model - with multiple sites TSD statistical model - with multiple sites	Two-Stage / GS Designs	earlybird	2009-10-16 11:25	5	2021-07-20 21:52	4,857
HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference HVD Pilot: 3 candidates, 1 reference	Design Issues	Shah	2021-07-16 13:40	3	2021-07-20 09:31	362
randomizeBE - randomness control randomizeBE - randomness control runs test - critical values randomizeBE - randomness control randomness control randomness control randomness control randomness control	R for BE/BA	d_labes	2012-07-10 13:02	7	2021-07-18 11:15	6,549
statistical approaches for dose-finding PK studies statistical approaches for dose-finding PK studies	Regulatives / Guidelines	Sridhar.E	2021-07-13 11:04	1	2021-07-17 19:04	227
BE for a drug dosed on body weight BE for a drug dosed on body weight	Study Performance	Achievwin	2021-07-06 14:37	1	2021-07-17 11:46	195
Bracketing approach for multiple strenght product EMA Bracketing approach for multiple strenght product EMA	Regulatives / Guidelines	jag009	2021-07-06 19:19	1	2021-07-17 11:44	212
Results Analysis Results Analysis Results Analysis Don’t hurry; explore consequences Don’t hurry; explore consequences The smaller a study, the more uncertain its results The smaller a study, the more uncertain its results The smaller a study, the more uncertain its results 156 ? 156 ? Results Analysis Results Analysis Results Analysis bootstrap bootstrap Bootstrapping BE: An attempt in 🇷 Bootstrapping BE: An attempt in 🇷 Bootstrapping BE: Desultory thoughts Bootstrapping BE: Desultory thoughts Bootstrapping BE: Desultory thoughts	Study Assessment	unique_one	2014-07-08 08:58	19	2021-07-09 21:04	10,087
Ethnicity of Indian population Ethnicity of Indian population Ethnicity of Indian population Ethnicity of Indian population	Regulatives / Guidelines	Vishal S	2021-06-22 07:25	3	2021-07-06 16:21	419
Outlier in fully replicate BE study Outlier in fully replicate BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study Widening for clopidogrel BE study - cherry-picking? Widening for clopidogrel BE study Hypotheses Hypotheses ABEL ≠ RSABE	Outliers	Loky do	2021-06-16 00:49	9	2021-07-06 16:17	782
CDCA / Chenodeoxycholic acid / Chenodiol CV%	Power / Sample Size	Mohamed Yehia	2021-07-05 11:11	0		153
End study requirements for Brazil submission End study requirements for Brazil submission	Regulatives / Guidelines	khageswara Rao	2021-07-01 08:43	1	2021-07-05 10:15	252
Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg Intrauterine Device – Levonorgestrel 52 mg	Design Issues	marianna.macera	2021-06-30 15:04	3	2021-07-02 17:18	270
WHO: scaling for AUC? WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: scaling for AUC confirmed No comparison of variabilities any more 😀	BE/BA News	Ohlbe	2017-06-12 13:29	7	2021-07-02 15:11	7,765
Calculation of % Liver FPE PBPK PBPK PBPK	PK / PD	pharm07	2021-06-30 05:33	3	2021-07-01 17:09	316