Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
EMA: Guideline on computerised systems and electronic data in clinical trials Validation!	Helmut	2021-06-30 10:41	1	2021-06-30 14:26	3,220
WHO guideline on data integrity	Ohlbe	2021-04-08 11:03	0		2,167
FDA: ANDA during COVID-19 pandemic	Helmut	2021-01-19 17:27	0		2,024
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	7,427
Dasatinib EMA, April 2020 What a relief!	ElMaestro	2020-06-21 11:49	1	2020-06-21 12:12	3,967
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	7,865
Russia: Changed procedure for determining drug interchangeability Russia: Changed procedure for determining drug interchangeability	Helmut	2020-02-21 13:20	1	2020-02-21 14:05	3,599
ICH M13 ICH M13 ICH pushed by GBHI? ICH pushed by GBHI? “Lively” discussions M9 step 4 now published And Japan? And Japan? ? business as usual	Helmut	2019-11-27 19:08	8	2019-12-04 14:42	9,634
September 2019: 34 new and 19 revised product-specific FDA BE guidelines	nobody	2019-09-24 10:58	0		3,301
BE in hepatic impairment?	nobody	2019-08-30 09:29	0		2,594
ICH E8(R1) step 2b ICH E8(R1) step 2b ICH E8(R1) step 2b	Helmut	2019-06-03 10:02	2	2019-06-04 02:03	4,553
FDA Web page Redesign of the FDA’s site: A rant ☠	Rosy	2019-05-03 16:28	1	2019-05-03 15:28	5,791
WHO Questions and Answers: similar biotherapeutic products	Helmut	2019-04-15 00:25	0		2,755
Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity? Pharmacokinetic Solidarity?	mittyri	2019-04-02 12:32	3	2019-04-02 11:37	4,877
News from EMA: Pharmacokinetic Solidarity	EMA.Press.Office	2019-04-01 00:07	0		3,842