Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology	suchit_bhavsar	2022-06-29 07:37	0		1,272
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	2,685
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	2,606
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	38,284
English translation of Japanese guidelines	Ohlbe	2021-10-26 11:48	0		1,436
GCC guidelines v3.0	Helmut	2021-10-25 20:03	0		1,474
4th GBHI report	Helmut	2021-09-29 18:03	0		1,505
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	3,667
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	11,821
EMA: Guideline on computerised systems and electronic data in clinical trials Validation!	Helmut	2021-06-30 10:41	1	2021-06-30 14:26	1,781
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	4,651