Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Regarding Dosing Regimen in BE study of Paracetamol SR 665mg	omprakash	2016-06-08 09:54	0		3,265
Selection of dose in BE study of Ivermectin 3 mg tabs for EU Strength (EMA) vs. dose (FDA) Strength (EMA) vs. dose (FDA)	Deep patel	2016-06-03 13:34	2	2016-06-04 11:18	6,875
multiple dose study 1999 Note for Guidance? 1999 Note for Guidance? Ask the applicant Ask the applicant	Mahesh M	2016-05-30 09:42	4	2016-06-01 06:45	7,292
Biowaiver for one strength/dose of non-linear PK	Tina	2016-05-26 13:58	0		2,981
Clomipramine BE study strength to be investigated	Sanjeith K	2016-05-25 12:17	0		3,749
PPI Washout PPI Washout PPI Washout	Jay	2016-05-11 08:57	2	2016-05-15 20:19	6,869
Reg-Bio Availability or Bio Equivalence study Bio Availability or Bio Equivalence study Bio Availability or Bio Equivalence study Different rates = BE if intentional (FDA def.) Different rates = BE if intentional (FDA def.) Bio Availability or Bio Equivalence study Bioequivalence study? Bioequivalence study? Bioequivalence study Bioequivalence study Investigation of ...	pravin17	2016-05-03 08:07	10	2016-05-10 20:03	11,773
Sas proc mixed and 4 period partial replicate Cross over What is the purpose? What is the purpose? Alpha inflation ? Alpha inflation Not with such a high CV High CV? Acc. to WHO PQTm Sofosbuvir	M.tareq	2016-05-03 11:35	8	2016-05-04 09:50	10,776
Omeprazole Omeprazole Omeprazole Omeprazole Cmax at tlast Omeprazole, widen of Cmax in a normal crossover design? Omeprazole reference = HVDP	joyjac	2012-05-15 09:22	6	2016-04-07 10:57	13,693
Study conduct in groups Study conduct in groups Study conduct in groups Study conduct in groups Study conduct in groups Study conduct in groups Study conduct in groups Significant ≠ relevant Significant ≠ relevant Significant ≠ relevant Significant ≠ relevant Loss of power etc. Loss of power etc. Loss of power etc. Combined power? Loss of power etc. Loss of power etc. Mystery Back to the Future Back to the Future Using lectures != Reading them Recycling Recycling Recycling	Smitha	2015-02-02 04:21	23	2016-03-30 11:00	31,947
How to plan steady state study? MD design based on SD data Something new from Russian regulators	BE-proff	2016-03-13 18:28	2	2016-03-19 13:25	7,264
Medroxyprogesterone Medroxyprogesterone Medroxyprogesterone Medroxyprogesterone Medroxyprogesterone	ratnakar1811	2016-03-10 07:13	4	2016-03-14 07:20	7,348
Non-availability of reference product EU rererence product marketed only in some members states rererence product marketed only in some members states rererence product marketed only in some members states rererence product marketed only in some members states rererence product marketed only in some members states	Sanjeith K	2016-02-26 09:41	5	2016-03-11 09:36	9,439
Naproxen 220mg Naproxen 220mg	aanrin	2016-03-07 08:36	1	2016-03-07 12:12	4,989
coefficient of variation intra-subject of imipramine	cristian_avv	2016-02-03 21:12	0		2,908