Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Prolonged release drug MR: Different shapes	Farmacevt	2021-07-30 17:31	1	2021-08-05 11:43	4,659
IV Infusion/Bolus Pk normalisation IV Infusion/Bolus Pk normalisation IV Infusion/Bolus Pk normalisation IV Infusion/Bolus Pk normalisation IV Infusion/Bolus Pk normalisation IV Infusion/Bolus Pk normalisation	pharm07	2021-06-22 11:09	5	2021-06-25 02:51	3,853
IVIVC in R Tutorials	Taonga Pomerai	2021-01-04 14:46	0		2,206
Simeticone soft gel capsule dissolution problem Simeticone soft gel capsule dissolution problem	mahonny	2015-03-31 13:12	1	2021-01-04 07:21	7,875
Dextromethorphan Dextromethorphan Dextromethorphan Dextromethorphan Dextromethorphan: Class II?	begoña	2020-10-08 12:14	4	2020-10-08 10:59	5,921
Biowaiver for lower strength using different OGD media EMA: No biowaivers for NTIDs EMA: No biowaivers for NTIDs Biowaiver only for BCS I and – under certain conditions – BCS III drugs Biowaiver only for BCS I and – under certain conditions – BCS III drugs Biowaiver only for BCS I and – under certain conditions – BCS III drugs Additional Strength Biowaiver Requirements Additional strength Biowaiver	dshah	2020-07-13 08:09	7	2020-07-18 16:00	5,968
how to use Loo Riegelman method and deconvolution how to use Loo Riegelman method and deconvolution how to use Loo Riegelman method and deconvolution how to use Loo Riegelman method and deconvolution	laili	2012-05-07 09:40	3	2020-07-16 11:31	8,783
Weibull method for Dissolution Similarlies Weibull method for Dissolution Similarlies Weibull method for Dissolution Similarlies Weibull method for Dissolution Similarlies Weibull method for Dissolution Similarlies	Jainee	2020-04-30 18:10	4	2020-05-10 09:35	6,597
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	jag009	2020-03-12 15:41	5	2020-03-15 09:05	6,702
Glycopyrrolate BCS Class Glycopyrrolate BCS Class	AB661	2020-01-29 10:12	1	2020-02-04 22:17	4,450
Bio-waiver of Sapropterin dihydrochloride powder for oral solution Please do your homework first Bio-waiver of Sapropterin dihydrochloride powder for oral solution	AB661	2019-11-22 17:49	2	2019-12-03 16:06	5,976
Dissolution Testing Requirement - ANDA	jag009	2019-10-30 02:29	0		2,542
If method doesn't exist in FDA Disso Database USP should be fine USP should be fine	jag009	2019-10-24 20:54	2	2019-10-30 01:23	5,374
Dissolution Media for Comparative Dissolution Study	ilee9009	2019-09-20 11:00	0		2,894
predicting in vivo PK profiles from in vitro data after establishing IVIVC external predictability for ivivc external predictability for ivivc identical pH identical pH R scripts/codes for in-vivo conc. Software validation, another round Deconvolution Software validation, another round Software validation, another round Software validation, another round Should we also consider to validate the validation? Who inspects the inspectors? Who inspects the inspectors? Sapienti sat R scripts/codes for in-vivo conc. Bioavailabity term in predicted in-vivo conc.	amer	2019-09-09 05:04	16	2019-09-13 10:59	10,433