Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Publication of the final ICH M10 guideline Publication of the final ICH M10 guideline Chromatograms	Ohlbe	2022-06-10 10:48	2	2022-06-14 09:37	2,498
New FDA bioavailability guidance New FDA bioavailability guidance New FDA bioavailability guidance Excellent post!	wienui	2022-04-15 09:44	3	2022-04-17 11:03	2,680
EMA: New product-specific guidances How would you implement it? Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Range Range Range Range So many questions, so few answers Preliminary simulations Preliminary simulations Preliminary simulations Revisions of the PSGLs final Revisions of the PSGLs final EMA: No problems with many sampling time points… New simulations & some desultory thoughts SCNR. A heretic alternative. Simulated distributions	Helmut	2022-04-08 15:17	19	2023-06-30 11:50	6,202
Bempedoic Acid TBM BE study in SBOA Bempedoic Acid TBM BE study in SBOA	dshah	2022-03-30 17:09	1	2022-03-31 06:43	2,050
Observational studies Observational studies … real-world evidence …	Helmut	2021-12-27 10:24	2	2022-02-11 09:38	2,604
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		1,435
GCC guidelines v3.0	Helmut	2021-10-25 20:03	0		1,473
4th GBHI report	Helmut	2021-09-29 18:03	0		1,504
FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021 Bias correction unveiled FDA guideline on BE, draft August 2021 FDA guideline on BE, draft August 2021	ElMaestro	2021-08-23 14:42	5	2021-09-10 18:47	3,659
EMA: Guideline on computerised systems and electronic data in clinical trials Validation!	Helmut	2021-06-30 10:41	1	2021-06-30 14:26	1,780
WHO guideline on data integrity	Ohlbe	2021-04-08 11:03	0		1,420
FDA: ANDA during COVID-19 pandemic	Helmut	2021-01-19 17:27	0		1,256
WHO frequent deficiencies in protocols and reports WHO frequent deficiencies in protocols and reports CI inclusion ≠ TOST CI inclusion ≠ TOST CI inclusion ≠ TOST CI inclusion ≠ TOST CI inclusion ≠ TOST CI inclusion operationally identical to TOST WHO lamenting about terminology? WHO lamenting about terminology? WHO lamenting about terminology? WHO frequent deficiencies in protocols and reports "obtain balanced groups" vs randomisation	Ohlbe	2020-12-04 12:04	12	2020-12-23 07:12	4,642
Dasatinib EMA, April 2020 What a relief!	ElMaestro	2020-06-21 11:49	1	2020-06-21 12:12	2,781
Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India Any CROs open for BA/BE studies in US/Europe/India	Achievwin	2020-04-25 00:24	7	2020-05-07 01:23	6,262