Bioequivalence and Bioavailability Forum • Clarification from Russian expert organization regarding telmisartan BE studies

Clarification from Russian expert organization regarding telmisartan BE studies [Regulatives / Guidelines]

posted by Beholder – Russia, 2019-11-08 08:51 (1628 d 12:19 ago) – Posting: # 20764
Views: 5,669
(edited by Beholder on 2019-11-08 11:27)

Hi to all!

An article which might serve as "guideline" for conducting telmisartan BE studies in Russia written by expert organization representative. Open access and abstract in English is available.

Main points represented in the article:

7 BE studies performed in Russia were assessed.
Not only males should be enrolled but females as well (50/50).
HPLC FLD is, in some cases, more sensitive than HPLC MS/MS (see study 3) .

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Best regards
Beholder

Complete thread:

Clarification from Russian expert organization regarding telmisartan BE studiesBeholder 2019-11-08 07:51 [Regulatives / Guidelines]
- Clarification from Russian expert organization… Helmut 2019-11-08 15:35
  - Questions mittyri 2019-11-08 22:00
    - Guesses & answers Helmut 2019-11-09 11:36
      - intergender differences and consequences mittyri 2019-12-04 08:53
        
        intergender differences and no consequences Helmut 2019-12-04 11:23
    - Questions Yura 2019-12-04 12:16
      - Questions Yura 2019-12-04 14:14
      - Careful PharmCat 2019-12-10 18:53
- Confusion from Russian expert organization Helmut 2019-12-03 12:19
- Clarification from Russian expert organization regarding telmisartan BE studies Mikalai 2019-12-09 18:27