Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
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	886
Dissolution Testing Requirement - ANDA	jag009	2019-10-30 02:29	0		308
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	1,149
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	2,200
Dissolution Media for Comparative Dissolution Study	ilee9009	2019-09-20 11:00	0		536
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	1,913
Biorelevant Dissolution - FeSSGF with Ensure Plus	thalita_m	2019-07-26 15:55	0		520
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	1,108
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	904
Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: a myth or coming reality? Virtual Bioequivalence: an update from PAGE (+TSD!) FDA not concerned about the type I error?	mittyri	2018-06-09 22:39	4	2019-06-22 18:11	2,819
IVIVC with Bioequivalence Data IVIVC or not IVIVC? IVIVC or not IVIVC? Get Fabs if no iv data...	thalita_m	2019-06-18 01:55	3	2019-06-20 22:40	1,209
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 IVIVC calculations IVIVC calculations	mahendra	2013-10-24 16:10	32	2019-06-20 22:18	23,198
Is FDA dissolution database more preferable to product specific FDA BE guidance? Is FDA dissolution database more preferable to product specific FDA BE guidance?	yuvaneshwari	2019-04-18 11:12	1	2019-04-25 13:15	1,058
Dissolution similarity Dissolution similarity Dissolution similarity Mahalanobis distance - R code DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI DDSolver, Mahalanobis distance and its 90% CI	Nirali	2010-11-10 11:13	7	2019-03-07 19:23	19,643
BCS II waiver approach No way No way	yuvaneshwari	2019-01-23 06:09	2	2019-01-28 05:16	1,207