Bioequivalence and Bioavailability Forum

Subject	Category	Author	Posted	Rep.	last R.	Views
Need some clarity on eCTD module 5	Regulatives / Guidelines	jag009	2024-07-12 16:04	0		1,776
Fed dissolution with 20% glucose	Dissolution / BCS / IVIVC	yuva	2024-07-11 08:55	0		1,907
How to calculate %dissolved using USP Apparatus 4 (Open loop system)?	Dissolution / BCS / IVIVC	rezkighassani	2024-07-11 07:50	0		1,701
Decrease in PSD: Need to repeat BE? Type-II Variation Type-II Variation: Waive in-vivo study by providing in-vitro data? Type-II Variation: Waive in-vivo study by providing in-vitro data? Type-II Variation: Waive in-vivo study by providing in-vitro data?	Study Assessment	qualityassurance	2024-07-02 08:32	4	2024-07-04 12:19	3,583
Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs Standard deviation of different designs	General Statistics	BEQool	2024-06-27 12:25	8	2024-07-03 13:37	5,281
Consult animal trial design	Design Issues	libaiyi	2024-07-03 11:52	0		1,756
Consult trial design	Design Issues	libaiyi	2024-07-03 09:12	0		1,639
FDC: BA/BE study enough? FDC: DDI study generally sufficient	Regulatives / Guidelines	qualityassurance	2024-07-03 05:21	1	2024-07-03 08:05	2,668
back conversion test	Regulatives / Guidelines	Thair Saleh	2024-07-01 09:42	0		1,653
BE between one injection vs multiple injection products BE between one injection vs multiple injection products	Design Issues	weiguo2122	2024-06-26 20:17	1	2024-06-27 15:07	2,435
average bioequivalence Partial replicate design: ABE	Regulatives / Guidelines	Mahmoud	2024-06-24 11:29	1	2024-06-27 08:00	2,520
Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data Case Report Form (CRF) as source data	GxP / QC / QA	Mais	2024-06-24 07:04	4	2024-06-26 06:23	3,589
simulating dissolution data beyond observed lab data simulating dissolution data beyond observed lab data simulating dissolution data beyond observed lab data simulating dissolution data beyond observed lab data	Dissolution / BCS / IVIVC	Achievwin	2024-06-07 15:42	3	2024-06-26 00:50	3,494
Another one? Confirmed Who cares? Who cares? Expert Questions about data manipulation Data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Questions about data manipulation Assessment report published Questions about data manipulation Questions about data manipulation OT Questions about data manipulation Update Health Canada recalls And the FDA… Another one?	GxP / QC / QA	Helmut	2023-07-19 09:04	20	2024-06-19 11:22	15,575
Therapeutic equivalence Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence? Therapeutic equivalence	Design Issues	kishorpatil	2011-02-08 10:24	8	2024-06-17 02:21	7,951