Bioequivalence and Bioavailability Forum

Dear all,

yesterday an updated version of the Q&A document (dated 22 June 2009) was published on EMEA's website: Questions & Answers: Positions on specific questions addressed to the EWP therapeutic subgroup on Pharmacokinetics (89KB PDF).

A new Topic was added:

   7. Bioequivalence studies for generic products containing clopidogrel

Following questions are covered:

1. Which substance should be studied in bioequivalence studies: the parent compound clopidogrel or the metabolite(s) of clopidogrel?
   
2. Is demonstration of bioequivalence under fed conditions necessary in addition to the demonstration under fasting conditions?
   
3. Bioanalytical methods: Should there be any special requirements to ensure that the risk of back-conversion of the major metabolite to clopidogrel could be excluded?
   
4. Could the acceptance criteria for C_max be widened to 75-133%?

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Edit: Today (2009-08-04) Rev. 1 (dated 23 July 2009) was published. Nothing essential changed; some abbreviations were explained and LC-MS-MS was given only as an example analytical technique. [Helmut]