Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
Type of study in modified release formulation EMEA Type of study in modified release formulation EMEA Type of study in modified release formulation EMEA Type of study in modified release formulation EMEA Type of study in modified release formulation EMEA Type of study in modified release formulation EMEA Scaling of Cmin Scaling of Cmin Scaling of Cmin Steady state Steady state Scaling of Cmin Scaling of Cmin Scaling of Cmin Scaling of Cmin Scaling of Cmin Scaling of Cmin Scaling of Cmin Scaling of Cmin	Compliance	2014-03-13 09:43	18	2017-02-06 07:55	19,575
BEQ study between different strengths BEQ study between different strengths BEQ study between different strengths	Aga	2017-01-09 15:13	2	2017-01-17 10:42	6,577
Regarding BABE licence	rajasekhar	2017-01-11 13:52	0		2,517
PI change in a BE study PI change in a BE study	Swastik	2016-12-22 18:57	1	2016-12-25 06:21	3,425
Fasting & Fed Study based on USFDA Guidelines ANDA Submissions – Refuse-to-Receive Standards Fasting & Fed Study based on USFDA Guidelines	Mei San	2016-10-24 04:29	2	2016-12-18 06:37	6,960
Dexmethylphenidate - why 4-way replicate? Dexmethylphenidate - why 4-way replicate?	BRB	2016-12-13 22:19	1	2016-12-18 06:29	4,119
TS.xpt for bioequivalence study CDISC SDTM	mwagh	2016-12-16 11:07	1	2016-12-16 12:19	4,946
ICH E6 R(2)-GCP FINAL Guideline ICH E6 R(2) step 5	vish14184	2016-12-12 16:19	1	2016-12-15 15:40	3,789
Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability Montelukast BE study - Cmax shows supra bioavailability	elam	2016-12-01 08:20	6	2016-12-04 07:59	12,229
PK sample time points PK sample time points PK sample time points	Naren	2016-12-02 12:29	2	2016-12-03 08:49	4,276
Interpretation 'after the conduct of the study' ref:Guideline of BABE CDSCO Interpretation 'after the conduct of the study' ref:Guideline of BABE CDSCO	ravi.shah206	2016-12-02 07:22	1	2016-12-02 09:35	3,759
FDA requirement for Safety data for ANDAs SDTM FDA requirement for Safety data for ANDAs SDTM FDA requirement for Safety data for ANDAs SDTM FDA requirement for Safety data for ANDAs SDTM	Sriraj	2016-11-25 10:14	3	2016-12-02 09:22	6,342
New FDA CDISC requirements for ANDAs New FDA CDISC requirements for ANDAs New FDA CDISC requirements for ANDAs	lechia	2016-09-19 21:37	2	2016-11-22 21:33	8,617
Fluid restriction Fluid restriction	Vyas	2016-10-25 14:30	1	2016-11-02 14:21	3,643
Russia: List of accredited medical institutions Russia: List of accredited medical institutions Russia: List of accredited medical institutions Russia: List of accredited medical institutions Russia: List of accredited medical institutions	Helmut	2016-10-31 01:35	4	2016-10-31 10:30	6,137