Bioequivalence and Bioavailability Forum

54 matches found.

• ICH M13A & FDA Bioequivalence Guideline about missing data kimhuang 2026-06-15 08:33 [Regulatives / Guidelines]
• wilcox.text() Helmut 2026-04-26 11:44 [🇷 for BE/BA]
• EMA: Cut-off times of partial AUC? Helmut 2025-07-17 14:46 [Regulatives / Guidelines]
• The minefield… Helmut 2024-02-16 16:59 [Regulatives / Guidelines]
• Tmax 90% confidence interval Achievwin 2023-09-09 14:44 [Regulatives / Guidelines]
• SCNR. A heretic alternative. Helmut 2023-06-30 13:50 [BE/BA News]
• New simulations & some desultory thoughts Helmut 2023-06-29 13:34 [BE/BA News]
• tmax ≠ Cmax 🙂 Helmut 2023-06-27 19:03 [NCA / SHAM]
• optimizing schedule for late concentrations > LLOQ Helmut 2022-07-21 14:21 [NCA / SHAM]
• Simulated distributions Helmut 2022-05-02 15:43 [BE/BA News]
• Continuous variable → mean Helmut 2022-05-02 02:05 [General Sta­tis­tics]
• Preliminary simulations Helmut 2022-04-30 16:59 [BE/BA News]
• So many questions, so few answers Helmut 2022-04-11 15:03 [BE/BA News]
• Confuse a Cat Inc. Helmut 2022-04-09 20:40 [BE/BA News]
• EMA: New product-specific guidances Helmut 2022-04-08 17:17 [BE/BA News]
• AUCrefTmax (Health Canada) dshah 2021-05-31 12:15 [Regulatives / Guidelines]
• WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 20:00 [BE/BA News]
• Aber meine Dame, das ist alles Unsinn! Helmut 2020-06-08 03:04 [Regulatives / Guidelines]
• “Average” plots Helmut 2019-04-25 21:06 [NCA / SHAM]
• Graphing Mean PK profile Helmut 2019-04-24 00:23 [🇷 for BE/BA]
• Cherry-picking? Helmut 2018-09-12 14:34 [Study As­sess­ment]
• Clinical significance of Tmax Helmut 2017-10-12 15:22 [Regulatives / Guidelines]
• Clinical significance of Tmax M.tareq 2017-10-12 09:53 [Regulatives / Guidelines]
• Tmax evaluation for parallel groups in R Helmut 2015-10-03 17:26 [Software]
• Nitrofurantoin BE study pjs 2015-08-07 06:10 [Regulatives / Guidelines]
• sequence stratified WMW test d_labes 2014-08-26 18:19 [Nonparametrics]
• Discontinuations and Withdrawal kvgreddy06 2013-10-09 15:09 [Design Issues]
• tmax in EEA applications Helmut 2013-06-22 20:40 [Surveys]
• tmax (DR & multiphasic) Helmut 2013-06-22 03:15 [Regulatives / Guidelines]
• No stats Helmut 2013-05-23 14:03 [General Sta­tis­tics]
• Median tmax from pilot studies Helmut 2013-02-28 15:02 [Regulatives / Guidelines]
• Median tmax intuitivepharma 2013-02-28 14:05 [Regulatives / Guidelines]
• Sorry for the overgeneralization Helmut 2013-02-20 17:54 [Regulatives / Guidelines]
• Median tmax luvblooms 2013-02-20 06:03 [Regulatives / Guidelines]
• Median tmax jag009 2013-02-19 22:18 [Regulatives / Guidelines]
• Median tmax Helmut 2013-02-19 21:28 [Regulatives / Guidelines]
• Median tmax Helmut 2013-02-19 18:49 [Regulatives / Guidelines]
• Memantine? Helmut 2012-08-01 17:09 [PK / PD]
• FDA more straight? Helmut 2012-03-08 13:51 [BE/BA News]
• Median Tmax #1001 d_labes 2012-02-09 13:51 [General Sta­tis­tics]