Bioequivalence and Bioavailability Forum

Subject	Author	posted	Replies	last R.	Views
Dissolution Media for Comparative Dissolution Study	ilee9009	2019-09-20 11:00	0		307
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	1,128
Biorelevant Dissolution - FeSSGF with Ensure Plus	thalita_m	2019-07-26 15:55	0		356
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	690
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	595
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	900
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	834
BCS II waiver approach No way No way	yuvaneshwari	2019-01-23 06:09	2	2019-01-28 05:16	978
Solubility Testing-Shake flask method	ramgopi	2018-12-03 13:30	0		776
BCS Biowaiver for oral suspension BCS Biowaiver for oral suspension BCS Biowaiver for oral suspension BCS Biowaiver for oral suspension BCS Biowaiver for oral suspension	averroes1304	2018-11-19 21:14	4	2018-11-27 03:50	1,808
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	1,570
Class I BCS based biowaiver with different amounts of API between T and R Class I BCS based biowaiver with different amounts of API between T and R Class I BCS based biowaiver with different amounts of API between T and R	joosefupas	2018-11-08 11:00	2	2018-11-12 09:49	1,188
BCS Based Biowaiver application Price?	joosefupas	2018-10-19 14:54	0		902
Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver Solubility based Biowaiver	Amalia	2018-10-01 11:04	10	2018-10-06 19:59	2,974
f2 computation (for pts > 85%) f2 computation (for pts > 85%) f2 computation (for pts > 85%) f2 computation (for pts > 85%) f2 computation (for pts > 85%) f2 computation (for pts > 85%) - WHO GL f2 computation (for pts > 85%) - WHO GL f2 computation (for pts > 85%) - WHO GL f2 computation (for pts > 85%) - WHO GL	jag009	2018-09-10 18:41	8	2018-09-12 22:02	2,185