Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
⚠️ Read before registering 📌	Tips / Tricks	Helmut	2016-04-14 23:39	0		108,301
MR generic application MR generic application MR generic application MR generic application	Regulatives / Guidelines	Mikkabel	2020-03-16 16:40	3	2020-03-27 21:20	1,887
Meets primary objetive but not secondary objective	Study Assessment	Brus	2020-03-27 17:22	0		52
Steady State Bioequivalence Study Pre-dose samples Study design multiple dose stuy - circadian PK	Design Issues	Pharma_88	2020-01-08 10:07	2	2020-03-26 17:29	2,498
Impact of COVID-19 on HV trials Impact of COVID-19 on HV trials Impact of COVID-19 on HV trials	Study Performance	Laura R	2020-03-22 08:58	2	2020-03-25 09:51	1,211
protocol amendment that may trigger Group effect test protocol amendment that may trigger Group effect test	General Statistics	Silke	2020-03-24 08:52	1	2020-03-24 09:07	875
Dextromethophan	Study Performance	Rosy	2020-03-21 23:38	0		599
Dissolution and bracketing - EMA Dissolution and bracketing - EMA Dissolution and bracketing	Regulatives / Guidelines	Susanh	2020-03-19 18:39	2	2020-03-21 17:39	1,239
Outlier Test using R-Software and Phoenix WinNonlin software in the BE Outlier Test using R-Software and Phoenix WinNonlin software in the BE Studentized & standardized residuals Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test Outlier Test using R-Software: Lund test bear for outlier detection analysis?	Outliers	udayk	2020-03-06 09:00	6	2020-03-20 14:45	3,051
RLD batch number in fed and fast studies RLD batch number in fed and fast studies	Regulatives / Guidelines	Rana jaouni	2020-03-18 20:37	1	2020-03-18 20:46	1,733
USFDA Upper bound Criteria using R Software FDA’s RSABE not possible in R	R for BE/BA	sury	2020-03-17 05:55	1	2020-03-17 11:19	1,700
What is meant by data amenable?	Regulatives / Guidelines	GM	2020-03-16 12:59	0		1,350
Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Study planning 101 Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic Not enough subjects to say Not enough subjects to say Underrepresentation of female subjects in BE study to register Generic Underrepresentation of female subjects in BE study to register Generic	Regulatives / Guidelines	ping4santosh	2020-03-11 14:35	13	2020-03-16 09:13	3,696
Comp in-vitro disso studies for generics in India Comp in-vitro disso studies for generics in India Comp in-vitro disso studies for generics in India Comp in-vitro disso studies for generics in India Comp in-vitro disso studies for generics in India Comp in-vitro disso studies for generics in India	Dissolution / BCS / IVIVC	jag009	2020-03-12 15:41	5	2020-03-15 10:05	2,507
Bioequivalence Study without approved/marketed or no RLD Bioequivalence Study without approved/marketed or no RLD BE wo local originator	Regulatives / Guidelines	Pharma_88	2020-03-13 08:37	2	2020-03-13 10:51	2,194