Bioequivalence and Bioavailability Forum

162 matches found.

• Amoxicillin powder for suspension 125 mg/5ml and 250 mg/5ml BE studies for Canada bebacrk 2026-04-14 10:25 [Regulatives / Guidelines]
• Amoxicillin suspension BE study for Canada bebacrk 2026-02-16 12:37 [Design Issues]
• HC: outliers in replicate designs? Helmut 2026-02-13 11:33 [Regulatives / Guidelines]
• Fed → fasting Helmut 2025-09-04 10:26 [Design Issues]
• Comparator (formerly ‘reference product’) in BE Helmut 2025-08-01 10:41 [Regulatives / Guidelines]
• EMA: Cut-off times of partial AUC? Helmut 2025-07-17 14:46 [Regulatives / Guidelines]
• ICH M13 Guidance and Health Canada AB661 2024-10-01 07:09 [Regulatives / Guidelines]
• A rant Helmut 2024-08-26 14:52 [Two-Stage / GS Designs]
• 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]
• ABE or ABEL for Health Canada Helmut 2024-07-14 14:17 [Design Issues]
• Oxcarbazepine Tablet Study design AB661 2024-07-13 11:02 [Design Issues]
• Visual inspection of the fit! Helmut 2023-06-27 11:56 [Study As­sess­ment]
• Script for ABE and SABE (any applicable design) Helmut 2022-09-16 15:37 [🇷 for BE/BA]
• T/R potency <5% Helmut 2022-09-07 20:55 [Regulatives / Guidelines]
• From Potvin C to Inverse Normal: history (and outlook?) Helmut 2022-06-27 20:54 [Two-Stage / GS Designs]
• Typos… Helmut 2022-03-20 17:32 [Regulatives / Guidelines]
• AUC · k for variable inter-occasion CL Helmut 2021-10-01 01:31 [NCA / SHAM]
• AUCrefTmax (Health Canada) dshah 2021-05-31 12:15 [Regulatives / Guidelines]
• Scaling/Widening of AUC Helmut 2021-03-16 14:55 [Regulatives / Guidelines]
• Scaling/Widening of AUC Helmut 2021-02-24 16:29 [Regulatives / Guidelines]
• Sensitivity analysis (ABE, ABEL, RSABE) Helmut 2021-01-27 19:50 [🇷 for BE/BA]
• highly variable drugs-Cmax Helmut 2020-11-19 21:58 [Regulatives / Guidelines]
• Run on R v4.0.3 Helmut 2020-10-19 14:12 [Power / Sample Size]
• FARTSSIE v2.5 Helmut 2020-10-18 13:09 [Software]
• EMA: Hybrid MR vs IR (inter-individual variability) Helmut 2020-09-01 15:57 [Power / Sample Size]
• long half-life and large variability Helmut 2020-08-12 17:53 [Regulatives / Guidelines]
• BA drift Helmut 2020-07-21 17:10 [General Sta­tis­tics]
• Desultory thoughts Helmut 2020-07-15 19:33 [🇷 for BE/BA]
• Sample Size for Replicate studies arl_stat 2020-06-09 13:41 [Power / Sample Size]
• FDA ER vs. IR: Global Cmax Helmut 2020-05-09 13:54 [Regulatives / Guidelines]
• Tricky… Helmut 2020-01-30 13:07 [RSABE / ABEL]
• intergender differences and no consequences Helmut 2019-12-04 12:23 [Regulatives / Guidelines]
• Blind 2Stage Helmut 2019-05-30 14:56 [Two-Stage / GS Designs]
• Conclusion & beyond Helmut 2019-04-17 19:05 [NCA / SHAM]
• fixed & mixed (dammit!) and a request to SASians Helmut 2019-03-23 02:03 [Design Issues]
• 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]
• Strange result Helmut 2019-02-28 13:03 [Regulatives / Guidelines]
• Health Canada Study reports anky1212 2019-02-21 06:05 [Regulatives / Guidelines]