Bioequivalence and Bioavailability Forum • Pharmacokinetics linearity

Pharmacokinetics linearity [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2015-05-29 11:03 (3551 d 10:07 ago) – Posting: # 14881
Views: 4,362

Dear PJS
I do not know if I get things right, but IMHO the whole discussion would only make sense if you claim bioequivalence of your BE formulation (25mg/5ml sol which will be tested vs 25 mg tab ) also to the lower tablet strength (i.e. 5mg/1ml sol vs 25 mg tab). But as far as I understood you want to waive the 5mg/5ml strength. This is a different formulation (not dose proportional composition) and consequently you will need another BE study.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

Pharmacokinetics linearity pjs 2015-05-20 10:25 [Regulatives / Guidelines]
- Pharmacokinetics linearity pjs 2015-05-28 12:26
  - Pharmacokinetics linearity nobody 2015-05-28 13:44
    - Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
      - Pharmacokinetics linearity Dr_Dan 2015-05-28 14:32
        
        Pharmacokinetics linearity pjs 2015-05-28 14:58
        
        Pharmacokinetics linearity nobody 2015-05-28 15:50
        
        Pharmacokinetics linearity pjs 2015-05-28 16:11
        
        Pharmacokinetics linearityDr_Dan 2015-05-29 09:03