Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
BE guidences (USFDA) BE guidences (USFDA) BE guidences (USFDA) BE guidences (USFDA)	ashokraj	2015-07-10 06:59	3	2015-07-13 04:57	4,781
Use of 96.7% CI instead of 90% CI Use of 96.7% CI instead of 90% CI Bonferroni (three tests) Bonferroni (three tests) Bonferroni (three tests)	pjs	2015-07-08 17:07	4	2015-07-09 10:18	5,073
HC Proposed Policy on Bioequivalence Standards for HVDS HC Proposed Policy on Bioequivalence Standards for HVDS Bloody partial replicate again Bloody partial replicate again Which model? Which model? HC Proposed Policy on Bioequivalence Standards for HVDS AUC and Cmax HC for HVDs HC for HVDs Rounding Acceptable difference (BE history) Off topic Playing around with α (not exactly brilliant) Playing around with α (not exactly brilliant) Playing around with α (not exactly brilliant) OT – Philosophers on duty	balakotu	2015-07-02 09:05	16	2015-07-03 19:11	11,536
Co-investigators in place of Medical Investigator	docksr	2015-07-03 09:16	0		1,826
BENOC for anti cancer BENOC for anti cancer BENOC for anti cancer BENOC for anti cancer BENOC for anti cancer BENOC for anti cancer BENOC for anti cancer	accutest	2015-06-06 12:55	6	2015-07-02 05:18	7,214
GL on bioanalytical method validation EMEA/CHMP/EWP/192217/2	mmw	2015-06-05 14:25	0		3,207
Requirement of steady state study for MR product EMA	pjs	2015-06-04 13:33	0		2,720
Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity Pharmacokinetics linearity	pjs	2015-05-20 10:25	8	2015-05-29 07:03	6,796
Refuse-to-Receive Standards final guidance USFDA Guideline Revision – Refuse-to-Receive Standards	Samaya B	2014-09-17 10:25	1	2015-05-29 06:33	4,154
Celecoxib Capsules 400mg Dissolution	Anand	2015-05-19 07:33	0		3,252
Biowaiver of strengh in fixed combinatios Biowaiver of strengh in fixed combinatios Biowaiver of strengh in fixed combinatios	Averroes	2012-01-18 13:05	2	2015-05-18 12:38	4,821
FDA - Biowaiver Class III FDA - Biowaiver Class III FDA - Biowaiver Class III FDA - Biowaiver Class III FDA - Biowaiver Class III OT: Reality vs Guidance OT: Reality vs Guidance OT: Reality vs Guidance OT: Reality vs Guidance	nobody	2015-05-12 10:01	8	2015-05-15 14:40	6,183
BE study retention sample	elam	2015-05-12 10:30	0		2,913
exlusion of subject due to vomiting	docksr	2015-05-07 08:30	0		2,717
Exclusion of a subject from study due to diarrhea	docksr	2015-05-07 08:19	0		2,489