Bioequivalence and Bioavailability Forum

168 matches found.

• Bio­equi­va­lence Waiver for Lower Strengths of a BCS Class IV Drug praveen_mvln 2025-07-11 13:26 [Regulatives / Guidelines]
• Bio­equi­va­lence Waiver for Lower Strengths of a BCS Class IV Drug dshah 2025-07-07 13:07 [Regulatives / Guidelines]
• "Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 03:14 [Regulatives / Guidelines]
• ICH M13A: Changes to Step 2 Helmut 2024-08-05 14:53 [BE/BA News]
• ICH M13A: Changes to Step 2 Helmut 2024-07-31 16:19 [BE/BA News]
• Biowaiver and PK linearity - EU Susanh 2021-08-18 18:38 [Study As­sess­ment]
• Biowaiver for lower strength Vishal S 2021-08-06 13:12 [Study Per­for­mance]
• least common multiple of T and R Helmut 2021-05-24 14:32 [Design Issues]
• Simulations (lengthy 🇷 script) Helmut 2021-04-23 14:37 [🇷 for BE/BA]
• Requesting data for a publication 📥 ♻️ 🚀 Helmut 2021-04-08 19:09 [General Sta­tis­tics]
• Modified acceptance range, confirmatory vs. exploratory Helmut 2021-02-01 12:34 [Power / Sample Size]
• Sample size dosage strength pro­por­tion­ality study Laura R 2021-02-01 10:19 [Power / Sample Size]
• 505(j) = ANDA, 505(b)(2) NDA = ‘hybrid’ Helmut 2021-01-21 15:37 [Design Issues]
• OT: The Wild Bunch Helmut 2020-10-16 17:38 [PK / PD]
• Linear and Non-linear pharmacokinetics martin 2020-10-16 10:34 [PK / PD]
• Linear and Non-linear pharmacokinetics Helmut 2020-10-08 15:44 [PK / PD]
• Linear and Non-linear pharmacokinetics ElMaestro 2020-10-08 15:13 [PK / PD]
• EMA: ABEL for HVD(P)s, PK metrics Helmut 2020-08-31 14:21 [Regulatives / Guidelines]
• BABE 101 (lenghty and spiced with PK) Helmut 2020-07-23 18:02 [Software]
• Torasemide BE Study EU pmohite 2020-06-22 13:25 [Design Issues]
• Can of worms Helmut 2020-01-30 14:32 [Regulatives / Guidelines]
• Higher-order cross­overs sweiner 2020-01-26 17:50 [Power / Sample Size]
• Purpose of the study? Helmut 2020-01-23 14:48 [Power / Sample Size]
• steady state for modified release Helmut 2019-09-23 12:04 [Regulatives / Guidelines]
• Of historic(al) interest only sury 2019-03-20 06:04 [Power / Sample Size]
• Of historic(al) interest only Helmut 2019-03-19 14:27 [Power / Sample Size]
• 90% confidence interval for R_dnm Shuanghe 2019-01-07 18:11 [Study As­sess­ment]
• 90% confidence interval for R_dnm Shuanghe 2019-01-07 11:53 [Study As­sess­ment]
• Smith’s paper d_labes 2019-01-05 16:00 [Study As­sess­ment]
• 90% confidence interval for R_dnm d_labes 2019-01-05 15:01 [Study As­sess­ment]
• 90% confidence interval for R_dnm Shuanghe 2019-01-04 18:45 [Study As­sess­ment]
• Dose-proportionality versus dose-linearity martin 2018-08-07 15:04 [PK / PD]
• Dose-proportionality versus dose-linearity Ben 2018-08-06 21:39 [PK / PD]
• Dose-proportionality versus dose-linearity ElMaestro 2018-08-03 13:21 [PK / PD]
• Dose-proportionality versus dose-linearity martin 2018-08-03 12:25 [PK / PD]
• visualization of power-law model d_labes 2018-07-26 16:49 [General Sta­tis­tics]
• Cross validation: same concentration range Helmut 2018-07-25 14:39 [Bioanalytics]
• visualization of power-law model martin 2018-07-23 22:17 [General Sta­tis­tics]
• Deficiencies Helmut 2018-02-01 16:48 [Power / Sample Size]
• Type II variation Helmut 2018-01-24 12:56 [Design Issues]