Bioequivalence and Bioavailability Forum

169 matches found.

• Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product dshah 2026-02-18 08:04 [Regulatives / Guidelines]
• Truncated AUC or 3 Half-Lives? EMA BE Design for Inhaled Product A.Shtaiwi 2026-02-02 09:32 [Regulatives / Guidelines]
• long half-life AUC0-t or AUC0-72 ElMaestro 2025-10-15 19:41 [NCA / SHAM]
• IR with t½ ≥ 24 h Helmut 2025-10-14 12:30 [NCA / SHAM]
• long half-life AUC0-t or AUC0-72 Darborn 2025-10-14 07:34 [NCA / SHAM]
• ICH M13A: Changes to Step 2 Helmut 2024-07-31 16:19 [BE/BA News]
• EMA: No AUC(0-72h) for all MR products Helmut 2023-10-18 09:09 [Regulatives / Guidelines]
• Delayed Release For­mu­la­tion -AUC trun­cated at 72 h (AUC(0-72h)) JP2030 2023-10-18 07:58 [Regulatives / Guidelines]
• PK parameters Loky do 2022-05-11 17:45 [PK / PD]
• planning of bioequivalence sampling dshah 2021-11-01 11:34 [Bioanalytics]
• WHO frequent deficiencies in protocols and reports Helmut 2020-12-22 20:00 [BE/BA News]
• EMA: ABEL for HVD(P)s, PK metrics Helmut 2020-08-31 14:21 [Regulatives / Guidelines]
• EMA: AUC72 for all IR products pmohite 2020-06-24 14:08 [General Sta­tis­tics]
• Prof. Keller vs. Yamaoka mittyri 2020-06-17 16:28 [NCA / SHAM]
• Fantastic post ?? Helmut 2020-06-12 18:23 [NCA / SHAM]
• Fantastic PK parameters and where to find them Astea 2020-06-12 16:22 [NCA / SHAM]
• Aber meine Dame, das ist alles Unsinn! Helmut 2020-06-08 03:04 [Regulatives / Guidelines]
• Outlier in BE study Ohlbe 2020-04-29 17:19 [Study As­sess­ment]
• Outlier in BE study Amira Gouda 2020-04-28 17:36 [Study As­sess­ment]
• Science vs. regulations Helmut 2020-04-23 19:32 [Regulatives / Guidelines]
• Relevant: The PK metric with highest CV libaiyi 2018-05-24 12:02 [Power / Sample Size]
• Relevant: The PK metric with highest CV Helmut 2018-05-23 12:40 [Power / Sample Size]
• multiple units, lag-times Helmut 2018-02-13 14:31 [General Sta­tis­tics]
• LLOQ: higher or lower? cakhatri 2017-12-04 10:52 [Bioanalytics]
• PK parameters from multiple doses Yura 2017-11-21 12:48 [PK / PD]
• Truncted AUC, or AUCinf, which one ElMaestro 2017-08-17 12:47 [Design Issues]
• Truncted AUC, or AUCinf, which one ssussu 2017-08-17 12:15 [Design Issues]
• long half life drug bioequivalence study design ssussu 2017-08-16 13:45 [Design Issues]
• General BE topics Helmut 2017-06-06 16:24 [Design Issues]
• Partial AUC calculation Astea 2017-03-11 21:14 [NCA / SHAM]
• Denmark Curiosa (1 in 90% CI in 0.8-1.25) zizou 2017-02-05 03:03 [Power / Sample Size]
• FDA: crystal ball Averroes 2016-05-27 02:01 [Regulatives / Guidelines]
• if 75% of the subjects AUCt not covers at least 80% of AUCinf Dr_Dan 2016-03-15 09:49 [Study As­sess­ment]
• FDA: crystal ball Helmut 2015-12-29 16:43 [Regulatives / Guidelines]
• FDA: AUC0–72 Mahesh M 2015-12-29 14:51 [Regulatives / Guidelines]
• FDA: AUC0–72 Helmut 2015-12-29 14:12 [Regulatives / Guidelines]
• truncated design Mahesh M 2015-12-29 12:21 [Regulatives / Guidelines]
• Truncated 72 hours Helmut 2015-02-09 17:10 [NCA / SHAM]
• Truncated 72 hours mmw 2015-02-09 12:12 [NCA / SHAM]
• Difficulties with NCA BEAR yjlee168 2014-11-21 08:34 [🇷 for BE/BA]