Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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 18:00	862
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 13:31	5,411
IVIVC calculations IVIVC calculations IVIVC calculations IVIVC calculations Mergers IVIVC calculations PCDCON ⇒ IVIVC calculations IVIVC calculations IVIVC calculations Minitab etc. Minitab etc. XL XL XL XL XL Broken link XL XL XL Any news? Good News PBPK IVIVC PBPK IVIVC PBPK IVIVC Good News Contact Contact XL Jean-Michel Jean-Michel Jean-Michel Minitab etc. IVIVC calculations IVIVC calculations	mahendra	2013-10-24 16:10	34	2020-06-17 15:00	29,588
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 11:35	2,516
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 10:05	3,552
Glycopyrrolate BCS Class Glycopyrrolate BCS Class	AB661	2020-01-29 10:12	1	2020-02-04 23:17	1,219
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 17:06	2,098
Dissolution Testing Requirement - ANDA	jag009	2019-10-30 02:29	0		771
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 02:23	2,390
EMA: Mahalanobis distance is dead... EMA: Mahalanobis distance is dead... Is ƒ2 dead as well – always bootstrapping? Is ƒ2 dead as well – always bootstrapping? Ahem – number of units? Ahem – number of units? Ahem – number of units?	Helmut	2018-11-09 18:01	6	2019-10-07 19:11	3,672
Dissolution Media for Comparative Dissolution Study	ilee9009	2019-09-20 11:00	0		1,060
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 12:59	4,001
Biorelevant Dissolution - FeSSGF with Ensure Plus	thalita_m	2019-07-26 15:55	0		975
BSC approach at each strength? BSC approach at each strength? BSC approach at each strength? BSC approach at each strength? BSC approach at each strength? BCS approach at each strength?	Mauricio Sampaio	2019-07-19 22:29	5	2019-07-26 15:32	2,225
Statistical comparison of dissolution profiles - variable nr of units Statistical comparison of dissolution profiles - variable nr of units Statistical comparison of dissolution profiles - variable nr of units EU: No Mahalanobis	MSimoes	2019-07-17 18:13	3	2019-07-18 13:06	1,725