Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
European NfG Update? Concept Paper for Addendum to NfG: HVDs Q&A Document to European NfG Q&A Document to European NfG	Helmut	2005-09-20 14:58	3	2006-08-18 13:54	11,630
Individual and Population bioequivalence studies Individual and Population bioequivalence studies Individual and Population bioequivalence studies Netiquette (Off Topic) ABE, PBE, and IBE	sekhar91	2006-08-09 08:54	4	2006-08-18 14:28	8,127
IP Dispensing IP Dispensing IP Dispensing IP Dispensing	bserve	2006-04-12 08:45	3	2006-08-29 13:43	8,465
Closing analytical database	veena	2006-10-07 07:36	0		2,859
BE study after Time Lag BE study after Time Lag BE study after Time Lag Biowaiver rejected... Biowaiver rejected... Biowaiver rejected... Biowaiver rejected... Biowaiver rejected...	Regaffairs	2006-10-06 10:38	7	2006-10-10 13:02	9,086
renewal criteria for ANVISA renewal criteria for ANVISA	prashant modi	2006-10-14 12:48	1	2006-10-14 18:24	5,505
opening of a new ba/be unit opening of a new ba/be unit opening of a new ba/be unit opening of a new ba/be unit	eswar lal	2006-10-27 12:55	3	2006-10-30 10:10	5,898
BE study for injectables BE study for injectables	Lakshmi Rajyam	2006-10-31 06:36	1	2006-10-31 12:18	11,670
fed and fasting studies fed and fasting studies fed and fasting studies	ssk	2006-10-12 12:33	2	2006-11-02 17:07	5,455
pilot/pivotal pilot/pivotal pilot/pivotal BE demonstrated in pilot study pilot/pivotal pilot/pivotal	ssk	2006-08-14 09:27	5	2006-11-17 11:19	9,979
Withdrawal Criteria Withdrawal Criteria	Dr.Pravin	2006-11-21 09:32	1	2006-11-22 11:36	5,110
Bioequivalence criteria for study BE criteria changed after period 1	Dr.Pravin	2006-12-06 14:17	1	2006-12-06 13:50	4,910
adverse reaction reporting adverse reaction reporting adverse reaction reporting adverse reaction reporting GCP Regulation in India	makula_001	2006-12-04 08:40	4	2006-12-08 20:53	7,350
qualification of Principal Investigator Qualification of Principal Investigator (Germany, Austria) qualification of PI (USA) Responsibility of Principal Investigator in BA/BE Study Responsibility of PI in BA/BE Study Responsibility of PI in BA/BE Study Responsibility of PI in BA/BE Study PI in India	isra_amm	2006-04-29 14:38	7	2006-12-08 21:05	12,006
Statistical analysis of the withdrawal subjects Statistical analysis of the withdrawal subjects	Dr.Pravin	2006-12-16 08:31	1	2006-12-16 12:09	4,962