Bioequivalence and Bioavailability Forum

FDA: Update of PSGs to align with ICH M13A Helmut 2024-10-03 15:58
- FDA: ICH M13A, Q&A, PSGs, and a rant Helmut 2024-11-01 08:58

"Dose or Strength to be Studied" in ICH M13A Darborn 2024-09-30 01:14
- "Dose or Strength to be Studied" in ICH M13A BEQool 2024-10-07 10:33
  - "Dose or Strength to be Studied" in ICH M13A Darborn 2024-10-08 00:58

Draft guideline on quality and equivalence of topical products – still stuck? mittyri 2024-09-14 20:24
- Patience… Helmut 2024-09-18 08:22
  - MWP Ohlbe 2024-09-18 10:26
    - Final & published Helmut 2024-10-03 11:44

ICH M13 Guidance and Health Canada AB661 2024-10-01 05:09
- ICH M13A/C and Health Canada Helmut 2024-10-01 06:29

Pooling of studies? Helmut 2024-09-02 13:55
- coverage probability mittyri 2024-09-02 17:22
- M13 Ohlbe 2024-09-02 17:37
  - M13 Q&A Helmut 2024-09-06 08:31

Cholestyramine and colesevelam in Vitro binding studies jansari 2024-09-02 17:25

Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-05 18:50
- Acute and Sub-acute toxicity studies for FDA ANDAs NK 2024-08-06 04:06
  - Acute and Sub-acute toxicity studies for FDA ANDAs Achievwin 2024-08-27 02:42

EU Reference Medicinal Product – Flexible or Absolute? PE 2024-08-20 10:39
- EEA Reference Medicinal Product: Mandatory Helmut 2024-08-20 12:17

Predose concentration more than 5 % of Cmax NK 2024-08-05 06:07
- FDC or isomers: C0 > 5 % of Cmax Helmut 2024-08-05 08:36
  - FDC or isomers: C0 > 5 % of Cmax Achievwin 2024-08-05 19:08
    - Carryover. A Never Ending Story. Helmut 2024-08-05 22:39
  - Inducers/inhibitors Ohlbe 2024-08-08 18:09
    - Inducers/inhibitors Helmut 2024-08-09 08:26
- Predose concentration more than 5 % of Cmax qualityassurance 2024-08-05 12:48

FDC with ascorbic acid qualityassurance 2024-07-23 08:08
- FDC with ascorbic acid Ohlbe 2024-07-23 09:55
  - FDC with ascorbic acid qualityassurance 2024-07-23 10:13
    - Placebo? Helmut 2024-07-23 12:39
      - Placebo? mittyri 2024-07-23 14:54
        
        🇦🇹 AGES Helmut 2024-07-24 11:16
      - Placebo? qualityassurance 2024-07-24 11:37
        
        Sorry – wrong addressee Helmut 2024-07-24 13:31
        
        lucky mittyri 2024-07-24 16:01

Brazil, Mexico: Proc GLM or Proc Mixed? jag009 2024-07-17 20:29
- Brazil, Mexico: Proc GLM? Helmut 2024-07-18 09:01
  - Mexico: new guideline Ohlbe 2024-07-18 09:40
    - Mexico: ABEL Helmut 2024-07-18 10:42
      - Mexico: ABEL NK 2024-07-19 07:30
        
        Mexico: ABEL Helmut 2024-07-19 09:26
        
        Mexico: ABEL jag009 2024-07-23 19:43

full replicate study for drug not highly variable - EMA perspective Ankit Parikh 2024-07-11 04:40
- EMA: Full replicate study Helmut 2024-07-15 09:13

Need some clarity on eCTD module 5 jag009 2024-07-12 16:04

FDC: BA/BE study enough? qualityassurance 2024-07-03 05:21
- FDC: DDI study generally sufficient Helmut 2024-07-03 08:05

back conversion test Thair Saleh 2024-07-01 09:42

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