Bioequivalence and Bioavailability Forum

83 matches found.

• In-vitro microbial kill rate study kumarnaidu 2019-04-26 12:31 [Study As­sess­ment]
• in-vitro population bioequivalence kumarnaidu 2019-02-06 07:50 [Regulatives / Guidelines]
• In-vitro Population Bioequivalence kumarnaidu 2019-02-05 16:32 [Regulatives / Guidelines]
• Clinical significance of Tmax kumarnaidu 2018-11-01 15:01 [Regulatives / Guidelines]
• What's the problem? kumarnaidu 2017-07-11 16:43 [Regulatives / Guidelines]
• PROC GLM fixes Subject kumarnaidu 2016-11-07 13:42 [🇷 for BE/BA]
• PROC GLM fixes Subject kumarnaidu 2016-11-07 07:24 [🇷 for BE/BA]
• PROC GLM fixes Subject kumarnaidu 2016-11-05 06:22 [🇷 for BE/BA]
• Fixed or random effect kumarnaidu 2016-11-04 15:05 [🇷 for BE/BA]
• Batch-to-Batch Pharmacokinetic Variability kumarnaidu 2016-07-20 09:16 [Regulatives / Guidelines]
• Skin adhesion BE study kumarnaidu 2016-06-10 08:56 [General Sta­tis­tics]
• Skin adhesion BE study kumarnaidu 2016-05-13 10:19 [General Sta­tis­tics]
• Regarding regulatory acceptability of Pilot study data as submission study kumarnaidu 2016-01-28 10:58 [Regulatives / Guidelines]
• Azithromycin kumarnaidu 2016-01-13 12:01 [Design Issues]
• Azithromycin kumarnaidu 2016-01-11 13:51 [Design Issues]
• Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 08:02 [Study As­sess­ment]
• Problematic design kumarnaidu 2014-12-26 06:38 [Design Issues]
• Problematic design kumarnaidu 2014-12-24 13:56 [Design Issues]
• Draft Guidance on Budesonide ER Released kumarnaidu 2014-12-15 12:15 [Regulatives / Guidelines]
• Steady state kumarnaidu 2014-12-10 12:15 [Regulatives / Guidelines]
• No RSABE kumarnaidu 2014-12-09 15:19 [Regulatives / Guidelines]
• Five PK metrics + S×F interaction kumarnaidu 2014-12-09 09:36 [Regulatives / Guidelines]
• Update: S×F vari­­ance test kumarnaidu 2014-12-09 07:48 [Regulatives / Guidelines]
• Scaling of Cmin kumarnaidu 2014-12-05 07:03 [Regulatives / Guidelines]
• Published ! kumarnaidu 2014-11-28 07:20 [Regulatives / Guidelines]
• Scaling of Cmin kumarnaidu 2014-11-27 16:12 [Regulatives / Guidelines]
• Type of study in modified release formu­lation EMEA kumarnaidu 2014-11-27 13:53 [Regulatives / Guidelines]
• Type of study in modified release formu­lation EMEA kumarnaidu 2014-11-27 12:02 [Regulatives / Guidelines]
• Draft FDA guidance on Methylphenidate Hydrochloride kumarnaidu 2014-11-10 09:16 [Regulatives / Guidelines]
• Epilim Chrono 500 CR tablets kumarnaidu 2014-10-13 14:39 [Regulatives / Guidelines]
• FDA: 90% CI for RSABE kumarnaidu 2014-08-20 15:30 [RSABE / ABEL]
• Model bioequivalence data summary tables-FDA kumarnaidu 2014-08-20 09:04 [RSABE / ABEL]
• Unit conversions, F ≤1? kumarnaidu 2014-07-21 13:01 [Software]
• Unit conversions, F ≤1? kumarnaidu 2014-07-14 14:23 [Software]
• CL and Vd calculations in WinNonlin kumarnaidu 2014-07-11 09:29 [Software]
• Change of API and fate of biostudy kumarnaidu 2014-06-27 12:54 [Regulatives / Guidelines]
• PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-19 08:04 [RSABE / ABEL]
• PowerTOST and Sample size estimation for R-SABE kumarnaidu 2014-04-18 15:38 [RSABE / ABEL]
• Replicate Pilot study kumarnaidu 2014-04-14 08:22 [Power / Sample Size]
• Replicate Pilot study kumarnaidu 2014-04-11 14:45 [Power / Sample Size]