Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
September 2019: 34 new and 19 revised product-specific FDA BE guidelines	nobody	2019-09-24 10:58	0		4,254
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	12,916
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	5,400
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	10,803
Dasatinib EMA, April 2020 What a relief!	ElMaestro	2020-06-21 11:49	1	2020-06-21 12:12	5,876
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	11,974
FDA: ANDA during COVID-19 pandemic	Helmut	2021-01-19 17:27	0		3,050
WHO guideline on data integrity	Ohlbe	2021-04-08 11:03	0		3,280
EMA: Guideline on computerised systems and electronic data in clinical trials Validation!	Helmut	2021-06-30 10:41	1	2021-06-30 14:26	5,330
WHO: scaling for AUC? WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: Chapeau! WHO: scaling for AUC confirmed No comparison of variabilities any more? WHO: scaling for AUC confirmed EMA: scaling for AUC = utopia	Ohlbe	2017-06-12 13:29	9	2021-08-03 10:54	18,507
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	8,838
4th GBHI report	Helmut	2021-09-29 18:03	0		3,801
GCC guidelines v3.0	Helmut	2021-10-25 20:03	0		3,503
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		3,398
EMA BE-GL: Clarifications / Corrections? Good news!? Good news!? Update Q&A published 14 March 2011 Q&A published 14 March 2011 Phoenix/WinNonlin 6.1.0.173 ANOVA party prevails THX! Outlier Outliers - yes, but how? Questions and Ambiguities Residuals and Outliers in Replicate Design Crossover Studies Info requested Confused as well... Q&A published 14 March 2011 SAS code: Warning Copy & paste Subtleties, flaws, questions Subtleties, flaws, questions Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Food not the same between groups Food not the same between groups	Helmut	2010-06-22 18:53	26	2021-11-17 08:50	53,703