Bioequivalence and Bioavailability Forum

495 matches found.

• Yessir! Sim’s and real data… Helmut 2026-05-01 16:19 [BE/BA News]
• ANVISA: Q&A of March 2026 Helmut 2026-04-29 15:02 [BE/BA News]
• Bioanalytical cross validation Brus 2026-02-25 14:20 [Bioanalytics]
• Phoenix: What to do if pre-dose is greater than the peak conc jag009 2025-09-16 06:29 [Software]
• steady-state in patients qualityassurance 2025-01-09 11:59 [Design Issues]
• steady-state in patients Helmut 2024-12-17 10:45 [Design Issues]
• Do regulatory agencies accept steady-state equivalence studies? xtianbadillo 2024-12-16 21:59 [Design Issues]
• HVD(P)s: steady state = history dshah 2024-12-05 08:22 [Design Issues]
• HVD(P)s: steady state = history libaiyi 2024-12-04 10:52 [Design Issues]
• HVD(P)s: steady state = history Helmut 2024-12-04 10:37 [Design Issues]
• Do regulatory agencies accept steady-state equivalence studies? libaiyi 2024-12-04 09:34 [Design Issues]
• ICH M13A: Changes to Step 2 Helmut 2024-07-31 16:19 [BE/BA News]
• 2-period full replicate design for IR formulation – EMA perspective Ankit Parikh 2024-07-11 06:58 [Regulatives / Guidelines]
• full replicate study for drug not highly variable - EMA perspective Ankit Parikh 2024-07-11 06:40 [Regulatives / Guidelines]
• No, sorry Ohlbe 2024-05-21 14:41 [Design Issues]
• Single dose PK study on Patients Ohlbe 2024-05-15 11:39 [Design Issues]
• Single dose PK study on Patients Pharma_88 2024-05-15 07:37 [Design Issues]
• AUC in steady state Helmut 2024-01-27 23:16 [Design Issues]
• AUC in steady state dshah 2024-01-27 23:06 [Design Issues]
• AUC in steady state Helmut 2024-01-27 23:01 [Design Issues]
• Css level? dshah 2024-01-26 11:03 [Regulatives / Guidelines]
• Circadian rhythm? Helmut 2024-01-20 13:50 [Design Issues]
• Steady state BE study dosing NK 2024-01-19 05:24 [Design Issues]
• Single-dose study in patients Helmut 2023-12-10 10:43 [Design Issues]
• Don’t worry, be happy! Helmut 2023-12-06 17:30 [Study As­sess­ment]
• Stabilization period Achievwin 2023-06-30 17:13 [Design Issues]
• tmax ≠ Cmax 🙂 BEQool 2023-06-27 20:25 [NCA / SHAM]
• tmax ≠ Cmax 🙂 Imph 2023-06-27 19:33 [NCA / SHAM]
• tmax ≠ Cmax 🙂 Helmut 2023-06-27 19:03 [NCA / SHAM]
• Which software? Imph 2023-06-27 18:56 [NCA / SHAM]
• Stabilization period dshah 2023-06-27 10:46 [Design Issues]
• Documentation of SS for LAI Achievwin 2023-02-06 14:40 [Design Issues]
• Do your homework first Helmut 2022-09-01 18:40 [Regulatives / Guidelines]
• Application of 90% CI for Ctau Mithu 2022-09-01 08:55 [Regulatives / Guidelines]
• AUCtau and Ctau calculation Shatha 2022-08-27 03:36 [Study As­sess­ment]
• Regulatory acceptance pre-mature discontinuation of study dshah 2022-06-23 14:52 [Study Per­for­mance]
• Steady-state achieve­ment Helmut 2022-04-06 16:29 [Software]
• Steady-state achieve­ment Shatha 2022-04-06 13:38 [Software]
• Steady-state achieve­ment Helmut 2022-04-05 16:29 [Software]
• Hel­mert trans­for­ma­tion? Shatha 2022-04-05 14:00 [Software]