Bioequivalence and Bioavailability Forum

clopidogrel [Design Issues]

posted by Ohlbe – France, 2007-03-30 19:44 (7023 d 17:50 ago) – Posting: # 607
Views: 10,686

Dear Velupharm,

The situations where metabolites can be used instead of the parent compound are listed in the EU Note for guidance on bioequivalence and commented upon in the Q&A document issued by EMEA last year (see here).

In a presentation at the DIA Euromeeting on Wednesday this week Martin Olling from the Dutch Medicines Evaluation Board really insisted on the use of the parent compound whenever possible.

Exclusive use of a metabolite, especially a non-active metabolite, could lead to real problems and should be appropriately justified. I am not sure reference to the LOQ mentioned in the SmPC, deriving from a bioanalytical method developped 10 years ago or more, would be considered as a sufficient justification .

Regards
Ohlbe

Complete thread:

• clopidogrel velupharm 2007-03-30 16:58 
  • clopidogrelOhlbe 2007-03-30 17:44
  • clopidogrel Imran 2007-04-11 10:54
  • clopidogrel bioequivalence - PD endpoint drks 2007-05-29 07:53
    • clopidogrel bioequivalence - PD endpoint Helmut 2007-05-29 11:47
      • clopidogrel bioequivalence - PD endpoint drks 2007-05-30 10:13
        • clopidogrel bioequivalence - PD endpoint Helmut 2007-05-30 12:47
      • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 11:56
        • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-19 10:33
          • clopidogrel active metabolite Ohlbe 2009-01-21 23:42
            • Current EU-position Helmut 2009-07-31 14:24
              • Supportive data? ElMaestro 2009-07-31 19:10
                • Supportive data? Helmut 2009-07-31 19:39
                  • Supportive data? Ohlbe 2009-07-31 19:48
      • clopidogrel bioequivalence - PD endpoint lukamar 2009-01-13 12:35
        • clopidogrel bioequivalence - PD endpoint Helmut 2009-01-14 14:33
        • clopidogrel bioequivalence - PD endpoint Ohlbe 2009-01-17 17:57
    • clopidogrel bioequivalence - PD endpoint drdds 2007-06-04 09:08
    • clopidogrel bioequivalence - PD endpoint ElMaestro 2009-01-14 17:22