Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Draft guideline on quality and equivalence of topical products - still stuck?	mittyri	2024-09-14 20:24	0		129
Pooling of studies? coverage probability M13 M13 Q&A	Helmut	2024-09-02 13:55	3	2024-09-06 08:31	709
Cholestyramine and colesevelam in Vitro binding studies	jansari	2024-09-02 17:25	0		228
Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs Acute and Sub-acute toxicity studies for FDA ANDAs	Achievwin	2024-08-05 18:50	2	2024-08-27 02:42	781
EU Reference Medicinal Product – Flexible or Absolute? EEA Reference Medicinal Product: Mandatory	PE	2024-08-20 10:39	1	2024-08-20 12:17	725
Predose concentration more than 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax FDC or isomers: C0 > 5 % of Cmax Carryover. A Never Ending Story. Inducers/inhibitors Inducers/inhibitors Predose concentration more than 5 % of Cmax	NK	2024-08-05 06:07	6	2024-08-09 08:26	1,139
FDC with ascorbic acid FDC with ascorbic acid FDC with ascorbic acid Placebo? Placebo? 🇦🇹 AGES Placebo? Sorry – wrong addressee lucky	qualityassurance	2024-07-23 08:08	8	2024-07-24 16:01	1,348
Brazil, Mexico: Proc GLM or Proc Mixed? Brazil, Mexico: Proc GLM? Mexico: new guideline Mexico: ABEL Mexico: ABEL Mexico: ABEL Mexico: ABEL	jag009	2024-07-17 20:29	6	2024-07-23 19:43	1,347
full replicate study for drug not highly variable - EMA perspective EMA: Full replicate study	Ankit Parikh	2024-07-11 04:40	1	2024-07-15 09:13	1,128
Need some clarity on eCTD module 5	jag009	2024-07-12 16:04	0		679
2-period full replicate design for IR formulation - EMA perspective	Ankit Parikh	2024-07-11 04:58	0		688
FDC: BA/BE study enough? FDC: DDI study generally sufficient	qualityassurance	2024-07-03 05:21	1	2024-07-03 08:05	1,194
back conversion test	Thair Saleh	2024-07-01 09:42	0		665
average bioequivalence Partial replicate design: ABE	Mahmoud	2024-06-24 11:29	1	2024-06-27 08:00	1,111
Biocomparability study Biocomparability study	suchit_bhavsar	2024-06-12 09:01	1	2024-06-12 09:48	1,085