Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	Replies	last R.	Views
▼ Read before registering ▼	Tips / Tricks	Helmut	2016-04-14 23:39	0		86,458
What is the largest α (Alpha) & β (Beta) allowed by FDA? What do you want to achieve?	General Statistics	victor	2019-11-16 21:57	1	2019-11-17 01:26	76
Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia OT: Speak with the regulator Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia Reference drugs for triple combination test drug in Russia	Design Issues	Beholder	2019-11-13 12:47	9	2019-11-16 17:22	251
Impact of Parenteral hydration in a BE study Violation of GCP? Impact of Parenteral hydration in a BE study	Study Assessment	Cec75	2019-11-15 16:39	2	2019-11-15 21:51	73
IS response variations IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations More on IS response variations Not more on IS response variations Not more on IS response variations the run passes = there is no problem? the run passes = there is no problem?	Regulatives / Guidelines	Ohlbe	2019-09-04 19:03	14	2019-11-13 19:17	884
FDA's HVD SAS Code from Progesterone Guidance Proc MIXED vs. Proc GLM Proc MIXED vs. Proc GLM SAS vs. PHX SAS vs. PHX SAS vs. SAS SAS vs. SAS vs. Phoenix SAS vs. PHX SAS Warning (Note) on Proc Mixed Nut Job.. Second opinion (PHX 6.3) Second opinion (PHX 6.3) Second opinion (PHX 6.3) In praise of a full replicate Third opinion Compound Symmetry Compound Symmetry - SASian (1) Variance=0	RSABE / ABEL	jag009	2013-04-22 16:39	17	2019-11-12 13:01	15,456
Generic submission in India	Regulatives / Guidelines	jag009	2019-11-11 21:43	0		131
Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet Bio waiver for lower strength (250mg) Mycophenolate mofetil tablet	Regulatives / Guidelines	Nidhiya J S	2019-11-05 06:14	4	2019-11-11 10:51	292
Reporting of QA Reporting of QA Reporting of QA Reporting of QA	GxP / QC / QA	kishan_123	2019-11-06 15:27	3	2019-11-11 09:14	281
Inflation type one error Inflation type one error Inflation type one error Inflation type one error Inflation type one error: FDA Inflation type one error Inflation type one error Inflation type one error TIE = chance of passing at the border(s)	RSABE / ABEL	Mikalai	2019-11-05 18:59	8	2019-11-10 11:33	445
Missing periods in replicate designs Missing periods in replicate designs Missing samples Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs Missing periods in replicate designs: save the data? Missing periods in replicate designs: save the data? Missing periods in replicate designs: kill the data? Meaningful data? Missing periods in replicate designs Kenward-Roger? Kenward-Roger? Kenward-Roger ≥ Satterthwaite Kenward-Roger ≥ Satterthwaite Kenward-Roger - links Kenward-Roger - links degrees of freedom degrees of freedom	RSABE / ABEL	Helmut	2019-10-16 13:14	19	2019-11-09 19:11	1,091
Clarification from Russian expert organization regarding telmisartan BE studies Clarification from Russian expert organization… Questions Guesses & answers	Regulatives / Guidelines	Beholder	2019-11-08 07:51	3	2019-11-09 11:36	267
Denmark Curiosa (1 in 90% CI in 0.8-1.25) Kudos! Kudos! Joking! Thanks, and DKMA Power with a Danish twist Danish ultra-conservatism Danish ultra-conservatism Kudos to ElMaestro! Plausible Plausible to me too Plausible to me too Plausible to me too THX 3D Denmark Curiosa (1 in 90% CI in 0.8-1.25) Denmark Curiosa (1 in 90% CI in 0.8-1.25) Alternative CI for BE decision Alternative CI for BE decision Alternative CI for BE decision How decidedly odd How decidedly odd Alternative CI for BE decision No alternative No alternative No alternative? Dinamarka? OT: Czech beer Denmark Curiosa (1 in 90% CI in 0.8-1.25): Gone	Power / Sample Size	zizou	2017-02-05 02:03	28	2019-11-08 12:47	18,411
Evaluation of Solution stability (with post extracted matrix based samples)	Bioanalytics	Ravuri sindhura	2019-11-07 12:17	0		131
PuMas - introducing Julia in pharmacometrics PuMas - introducing Julia in pharmacometrics	Software	yjlee168	2019-11-06 23:44	1	2019-11-07 10:28	199