Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
History Lesson: FDA NDA Submission back in the 50s History Lesson: FDA NDA Submission back in the 50s	jag009	2013-03-19 20:42	1	2013-03-20 06:35	2,896
Selection of PI Selection of PI Selection of PI	Irukulla Shravan Kumar	2013-03-19 11:17	2	2013-03-19 12:11	3,086
Temperature and Relative Humidity Conditions Temperature and Relative Humidity Conditions Temperature and Relative Humidity Conditions	Irukulla Shravan Kumar	2013-03-19 04:59	2	2013-03-19 08:54	3,062
Centrifugation Timings Centrifugation temperature Centrifugation temperature Centrifugation temperature Centrifugation temperature rpm vs. ×g rpm vs. ×g	Irukulla Shravan Kumar	2013-03-18 07:02	6	2013-03-19 04:00	4,913
Check list for Chile Audit Check list for Chile Audit Check list for Chile Audit Check list for Chile Audit	Irukulla Shravan Kumar	2013-03-18 07:16	3	2013-03-18 10:16	6,399
T-License obtained for invitro testing T-License obtained for invitro testing T-License obtained for invitro testing T-License obtained for invitro testing	dpksangwan	2013-03-12 13:47	3	2013-03-18 09:23	3,522
Retention quantity for health canada	suchit_bhavsar	2013-03-14 12:36	0		2,379
Sulindac Metabolites Which agency? Which agency?	Noha Abdeljawad	2013-02-26 09:08	2	2013-03-05 10:11	4,960
Biowaiver FDCs biowaiver (Class I/III)	cakhatri	2013-02-28 11:37	1	2013-02-28 16:56	3,404
FDA dropout guideline for Emesis Median tmax Median tmax Median tmax Median tmax Intellectual horsepower Intellectual horsepower Intellectual horsepower Intellectual horsepower Intellectual horsepower Median tmax Sorry for the overgeneralization overgeneralization ???? overgeneralization ???? overgeneralization ???? Median tmax Median tmax from pilot studies	jag009	2013-02-19 16:16	16	2013-02-28 13:02	11,861
Partial Replicate Study Design (subjects considered for PK) Partial Replicate Study Design (subjects considered for PK) Partial Replicate Study Design (subjects considered for PK) incomplete data (without T) incomplete data (without T)	sandipmumbai	2013-02-26 11:03	4	2013-02-27 06:29	4,516
TMFs: Reflection paper Bioanalytical CROs, GCP, TMF - longish Bioanalytical CROs, GCP, TMF - longish GCP, GLP, GCLP GCP, GLP, GCLP GCP, GLP, GCLP	Helmut	2013-02-20 17:26	5	2013-02-25 23:01	5,082
Screening Validity period Screening Validity period	sumit	2013-02-22 13:40	1	2013-02-22 16:14	3,136
new strength new strength new strength less than proportional increase less than proportional increase	olacy	2012-11-07 10:46	4	2013-02-16 10:21	4,319
ANVISA Guideline	avinash	2013-02-14 09:47	0		2,045