Bioequivalence and Bioavailability Forum

Dear all,

EMA just published a “Concept paper on the development of product-specific guidance on demonstration of bioequivalence” (EMA/CHMP/423137/2013).

From the paper:

4. Recommendation

The Pharmacokinetic Working Party recommends drafting product-specific guidance on the demonstration of bioequivalence.

It is planned that such guidance is first developed for immediate release formulations for oral use. The guidance is based on the general principles set out in the applicable overarching Guideline on the Investigation of Bioequivalence, and summarises in a standardised format the relevant design
principles for bioequivalence demonstration. The following items should be addressed in the guidance:

• Classification according to the Biopharmaceutical Classification Scheme (BCS) if a BCS biowaiver seems possible.
  
• Design elements of a bioequivalence study, i.e. administration schedule, study participants, conditions for administration (fasting/ fed) , strength to be investigated, and number of studies.
  
• Analyte for the bioequivalence demonstration, i.e. parent/metabolite, compartment (plasma/blood/urine), and need for an enantioselective method.
  
• Criteria for bioequivalence assessment, i.e. main pharmacokinetic variables and width of confidence intervals.

If required, a brief scientific rationale for the guidance will be provided.

5. Proposed timetable

The first set of product-specific guidance is planned to be adopted at the CHMP meeting in October 2013 for release for public consultation.

End of consultation is 30 Sep 2013.