Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
multilayer tablet exclusion criteria from PK analysis due to emesis multilayer tablet exclusion criteria from PK analysis due to emesis multilayer tablet exclusion criteria from PK analysis due to emesis tmax IR > tmax MR? tmax IR > tmax MR? multilayer tablet exclusion criteria from PK analysis due to emesis multilayer tablet exclusion criteria from PK analysis due to emesis multilayer tablet exclusion criteria from PK analysis due to emesis multilayer tablet exclusion criteria from PK analysis due to emesis	Mahesh M	2016-01-08 10:56	8	2016-02-01 12:14	7,240
Regarding regulatory acceptability of Pilot study data as submission study Regarding regulatory acceptability of Pilot study data as submission study	kumarnaidu	2016-01-28 09:58	1	2016-01-28 23:07	3,469
Newly Added Recommendations since December 31, 2015 (35 New; 12 Revisions) abiraterone: fasting+fed	Mahesh M	2016-01-28 12:57	1	2016-01-28 14:10	3,691
Bioequivalence Recommendations for Specific Products Bioequivalence Recommendations for Specific Products EMA: Draft product-specific guidances ♬ EMA: Draft product-specific guidances ♬ EMA: Capecitabine product-specific guidance ♬ EMA: Capecitabine product-specific guidance ♬ Russian GL 2013: harmonisation to EMA EMA: Draft product-specific guidances ♬ EMA: Use of AUC72 not dependent on t½ End of consultation approaching‼ End of consultation approaching‼ Guesstimates EMA: generally no product-specific GLs Thank you EMA: generally no product-specific GLs EMA: parent whenever possible EMA: parent whenever possible EMA: parent whenever possible EMA: parent whenever possible EMA: parent whenever possible EMA vs. Russia FDA: Prasugrel FDA: Prasugrel FDA: Prasugrel FDA: Alternative approaches… FDA: Alternative approaches… FDA: RTR FDA: RTR FDA: RTR WayBack Machine WayBack Machine Old stuff EMA: parent whenever possible EMA: Sirolimus product-specific GL	cr.maroj	2013-09-19 11:00	33	2016-01-28 12:32	37,038
Bioequivalence of ODT (Orodispersible Tablets) Bioequivalence of ODT (Orodispersible Tablets) Bioequivalence of ODT (Orodispersible Tablets) Crystal ball Crystal ball	Dr Ripal	2016-01-01 05:43	4	2016-01-06 07:03	6,447
Late phase clinical trial guidelines Thailand	Dr Ripal	2015-12-29 12:13	0		2,595
NTI drugs with moderate to high variability NTI drugs with moderate to high variability NTI drugs with moderate to high variability	arl_stat	2015-12-10 06:53	2	2015-12-14 05:00	4,886
Guidance Document for BE Study-Korean Regulatory Guidance Document for BE Study-Korean Regulatory Guidance Document for BE Study-Korean Regulatory Guidance Document for BE Study-Korean Regulatory Guidance Document for BE Study-Korean Regulatory	biopk	2015-11-19 08:14	4	2015-12-11 06:12	6,366
Product Specific - Magnesium Hydroxide tablets	bkrao	2015-12-10 07:41	0		3,171
Different N's for different analytes? Different N's for different analytes? Different N's for different analytes? Different N's for different analytes? Different N's for different analytes	ddubins	2007-12-05 16:16	4	2015-12-09 08:13	6,991
WHO Retention WHO Retention	krish	2015-12-08 10:45	1	2015-12-08 12:12	4,340
Difference between tablet and film tablet Difference between tablet and film tablet Difference between tablet and film tablet Difference between tablet and film tablet Difference between tablet and film tablet	vivekanand	2012-11-16 11:16	4	2015-12-03 02:25	7,246
FDA BE: Truncate AUC for long half-life drug FDA BE: Truncate AUC for long half-life drug	jag009	2015-11-16 16:28	1	2015-11-16 15:51	4,232
New FDC - BE reference products New FDC - BE reference products New FDC - BE reference products New FDC - BE reference products	Dr_Dan	2015-11-03 09:27	3	2015-11-10 13:01	5,467
EMA - Newly published modified release guidance EMA - Newly published modified release guidance	mmw	2015-10-29 11:23	1	2015-10-31 12:14	5,411