Bioequivalence and Bioavailability Forum

Subject	Category	Author	posted	R’s	last reply	V’s
Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design Levothyroxine Sample size and study design	Power / Sample Size	lakshmiprasad	2018-04-11 15:09	4	2018-04-14 12:55	633
Oral Dispersible Tablet BE study USFDA submission Oral Dispersible Tablet BE study USFDA submission	Regulatives / Guidelines	Ramesh Ramalingam	2018-04-13 10:52	1	2018-04-13 21:23	410
Diclofenac SR fast or fed state study design Homework Homework Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design Diclofenac SR fast or fed state study design	Design Issues	Norah	2018-02-20 09:14	9	2018-04-13 08:22	1,955
f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison f2 comparison	Dissolution / BCS / IVIVC	jag009	2018-04-10 15:58	7	2018-04-13 07:48	891
bioequivalence of drug combination bioequivalence of drug combination bioequivalence of drug combination bioequivalence of drug combination	Regulatives / Guidelines	Norah	2018-04-02 12:29	3	2018-04-13 06:40	695
Primidone BE study for USFDA submission Primidone BE study for USFDA submission Primidone BE study for USFDA submission Primidone BE study for USFDA submission Primidone BE study for USFDA submission Primidone BE study for USFDA submission	Regulatives / Guidelines	Ramesh Ramalingam	2018-04-09 05:54	5	2018-04-12 15:01	626
[Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 Black Swan again [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 [Opinion] Should the 90% CI for GMR be required to encompass 1 Paper & Presentations Donald Schuirmann’s opinion	RSABE / ABEL	bebac_fan	2018-03-28 18:43	18	2018-04-10 14:41	1,910
In vitro Bioequivalence for suspension ophthalmic	Regulatives / Guidelines	weidson	2018-04-09 20:40	0		314
Selection of linearity range in bioanalysis	Bioanalytics	Deepti Maru	2018-04-07 17:48	0		343
Counterintuitive? Counterintuitive? Counterintuitive? Counterintuitive? Counterintuitive? What is clinically relevant? What is clinically relevant? What is clinically relevant? What is clinically relevant? What is clinically relevant? What is clinically relevant? What is clinically relevant? Korsmeyer–Peppas’ model	Design Issues	nobody	2018-04-03 11:16	12	2018-04-06 23:36	1,269
Inclusion criteria (ANVISA) Inclusion criteria (ANVISA) Inclusion criteria (ANVISA) RDC No 34 (2008) RDC No 34 (2008) RDC No 34 (2008) RDC No 34 (2008) ANVISA’s site ANVISA’s site ANVISA's site ANVISA’s site Inclusion criteria (ANVISA) Inclusion criteria (ANVISA)	Regulatives / Guidelines	maverick	2009-10-13 10:48	12	2018-04-05 00:18	5,575
FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID FDA: RSABE for NTID β = 1 – π	RSABE / ABEL	Jay	2018-03-26 13:31	5	2018-04-04 15:03	1,246
Full replicate designed study for Europe Full replicate designed study for Europe Full replicate designed study for Europe	RSABE / ABEL	balakotu	2018-03-31 11:59	2	2018-04-02 02:19	687
bioequivalence criteria for NTID bioequivalence criteria for NTID bioequivalence criteria for NTID GMR not relevant in ABE bioequivalence criteria for NTID	Regulatives / Guidelines	Biostats	2018-03-29 12:39	4	2018-03-30 11:19	1,188
FDA-Subject by formulation interaction (Switchability) Risking Refuse-to-Receive Risking Refuse-to-Receive Risking Refuse-to-Receive FDA-Subject by formulation interaction (Switchability)	Regulatives / Guidelines	sudy	2018-03-28 07:09	4	2018-03-28 21:35	745
Postural restriction Postural restriction Postural restriction Postural restriction Postural restriction Postural restriction Postural restriction	Design Issues	lakshmiprasad	2018-03-17 09:20	6	2018-03-27 10:17	1,078