Bioequivalence and Bioavailability Forum • Questions

Questions [Regulatives / Guidelines]

posted by mittyri – Russia, 2019-11-08 23:00 (2015 d 21:33 ago) – Posting: # 20772
Views: 6,259

Hi Helmut,

❝ In Table 3 three studies are give twice each. Could reproduce the pooled CV of C_max (43.57%). The upper limit 44.84% is based on a 75% CI. I would use a 80% CL. Given.

They stated above regarding 90% CI. Don't know what kind of distribution was used for CI calculation.

Questions:

what do you think about statement that males and females (50/50) should be enrolled, since RLD says regarding sex differences in PK? 'Otherwise the marketed formulation could be not BE for other gender'
what do you think about FLU results (study 3)? There's a comment in the text stated that LC-MSMS should be recommended since higher (!) concentrations were achieved with that method and LLOQ 0.5-3.0

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Kind regards,
Mittyri

Complete thread:

Clarification from Russian expert organization regarding telmisartan BE studies Beholder 2019-11-08 07:51 [Regulatives / Guidelines]
- Clarification from Russian expert organization… Helmut 2019-11-08 15:35
  - Questionsmittyri 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