Bioequivalence and Bioavailability Forum

FDA Web page Rosy 2019-05-03 16:28
- Redesign of the FDA’s site: A rant ☠ Helmut 2019-05-03 17:28

WHO Questions and Answers: similar biotherapeutic products Helmut 2019-04-15 00:25

Pharmacokinetic Solidarity? mittyri 2019-04-02 12:32
- Pharmacokinetic Solidarity? nobody 2019-04-02 12:39
  - Pharmacokinetic Solidarity? Helmut 2019-04-02 13:00
    - Pharmacokinetic Solidarity? nobody 2019-04-02 13:37

News from EMA: Pharmacokinetic Solidarity EMA.Press.Office 2019-04-01 00:07

Good bye! Fare well, Canary Wharf! And nevermore. Helmut 2019-03-11 23:40
- Good bye! Fare well, Canary Wharf! And nevermore. jag009 2019-03-12 03:14
  - Brexit Helmut 2019-03-12 09:57

Outliers: The FDA follows the EMA Helmut 2019-03-05 01:24
- Outliers: The FDA follows the EMA jag009 2019-03-06 19:23

All animals are equal, but some animals are more equal than others Helmut 2018-10-09 14:33

Redesign of the EMA’s website Helmut 2018-10-08 12:20

FDA: Dissolution Testing and Acceptance Criteria for IR… Helmut 2018-09-03 14:46

FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA Helmut 2018-08-09 10:52

EMA: Q&A Update Helmut 2013-11-15 13:53
- EMA: Q&A Update luvblooms 2013-11-16 06:36
  - The early bird gets the worm Helmut 2013-11-16 12:20
    - The early bird gets the worm but luvblooms 2013-11-16 14:23
      - Lambda Therapeutic Ltd.? Helmut 2013-11-16 15:25
        
        Lambda Therapeutic Ltd.? luvblooms 2013-11-16 19:24
- EMA: Q&A Update; Expected studies for Quetiapine PR Tablets viveksraut 2018-08-06 14:42

EMA: 2 product-specific guidances adopted Helmut 2018-06-26 14:40
- EMA: New product-specific draft guidances published mmw 2018-06-29 07:20
  - EMA: New product-specific draft guidance published Helmut 2018-07-05 15:11
- EMA: 5 product-specific guidances adopted Helmut 2018-08-03 16:52

New FDA BMV guideline Ohlbe 2018-05-21 16:28
- What a monster! Helmut 2018-05-21 17:47
  - What a monster! jag009 2018-05-24 03:19
    - Two Versions: May 21 & May 24 Obinoscopy 2018-07-29 18:13
- Repeats as part of investigations, ja oder nein? ElMaestro 2018-05-22 00:17
  - Repeats as part of investigations, ja oder nein? Ohlbe 2018-05-22 12:02
    - Two Versions: May 21 & May 24 Obinoscopy 2018-07-30 20:41
      - Requirements ⇒ recommendations Helmut 2018-08-01 11:12
        
        Requirements ⇒ recommendations Obinoscopy 2018-08-02 22:59

ICH M9 Draft Helmut 2018-07-16 14:49

Updated TPD BE guidances BRB 2018-06-18 22:53
- Updated TPD BE guidances Helmut 2018-06-19 01:32
- Canada-Comparative bioavaiability standards Sandeep 2018-06-27 12:36

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