Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
BE trial design as partial replicate and two stage BE trial design as partial replicate and two stage BE trial design as partial replicate and two stage EMA = PSRPH?	Silva	2014-04-17 08:57	3	2014-04-17 13:33	4,021
Cmax for enteric coated product Cmax for enteric coated product Cmax for enteric coated product	Ken Peh	2014-04-13 07:08	2	2014-04-14 13:44	2,967
Sample size for parallel 3-way	Silva	2014-03-28 18:03	0		1,625
Plasma sample storage duration from USFDA perspective Plasma sample storage duration from USFDA perspective Plasma sample storage duration from USFDA perspective Plasma sample storage duration from USFDA perspective Plasma sample storage duration from USFDA perspective Plasma sample storage duration from USFDA perspective	Keath	2014-03-24 10:00	5	2014-03-27 09:35	4,405
Draft FDA Guidance Dec 2013 First impressions First impressions What is Bioequivalence in the US really? Site of action vs. systemic circulation Draft FDA Guidance Dec 2013 Two-stage or RSABE Two-stage or RSABE Two-stage methods Two-stage methods RSABE RSABE RSABE RSABE RSABE RSABE Draft FDA Guidance Dec 2013 Draft FDA Guidance Dec 2013 End of consultation approaching‼ End of consultation approaching‼ End of consultation approaching‼ End of consultation approaching‼	pash413	2013-12-04 15:05	21	2014-03-26 14:28	24,433
Hypogonadal males Hypogonadal males Hypogonadal males Hypogonadal males Hypogonadal males Hypogonadal males	Tina	2014-03-25 15:33	5	2014-03-26 08:31	4,111
In-Vitro study In-Vitro study In-Vitro study In-Vitro study	pravin17	2014-03-25 05:34	3	2014-03-26 07:37	3,157
Investigational product destructions of BE studies Investigational product destructions of BE studies Investigational product destructions of BE studies Investigational product destructions of BE studies Investigational product destructions of BE studies	pravin17	2014-03-19 06:26	4	2014-03-26 06:29	3,831
GCP certification	Irukulla Shravan Kumar	2014-03-25 10:32	0		1,496
Retention of IPs for BE studies for Transdermal Systems Retention of IPs for BE studies for Transdermal Systems Retention of IPs for BE studies for Transdermal Systems	Keath	2014-03-18 12:27	2	2014-03-24 08:47	3,322
Sprinkle study in IR formulation Sprinkle study in IR formulation Sprinkle study in IR formulation Sprinkle study in IR formulation Sprinkle study in IR formulation	Compliance	2014-03-19 05:12	4	2014-03-20 15:35	4,251
Number of tablets - Retention at two different CROs Number of tablets - Retention at two different CROs Number of tablets - Retention at two different CROs Number of tablets - Retention at two different CROs	scorp2011	2014-03-18 07:35	3	2014-03-19 13:12	3,573
regulatory requirement for Injection products regulatory requirement for Injection products	balakotu	2014-03-18 07:34	1	2014-03-19 04:24	3,120
ODT vs. IR ODT vs. IR ODT vs. IR ODT vs. IR ODT vs. IR ODT vs. IR ODT vs. IR	mittyri	2014-03-08 15:24	6	2014-03-17 11:18	5,181
Difference between test and reference Assayed content Difference between test and reference ∆ <5% ⇒ T/R 95% ∆ <5% ⇒ T/R 95% ∆ <5% ⇒ T/R 95% Optimism T/R 90% to 110% for sample size estimation T/R 110% T/R 110% the basis of T/R in the Protocol the basis of T/R in the Protocol the basis of T/R in the Protocol the basis of T/R in the Protocol the basis of T/R in the Protocol the basis of T/R in the Protocol	nlpati	2013-10-10 13:40	15	2014-03-14 22:02	11,201