Ing. Helmut Schütz

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Questions & Answers

EU – EMA

EMA’s CHMP/EWP Pharmacokinetics Working Party (PKWP) published ‘Questions & Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party’ EMEA/618604/2008 Rev. 3 (26 January 2011; first version 22 January 2009  PDF^87KB; updates 22 June 2009  PDF^94KB, 23 July 2009  PDF^89KB, 22 July 2010  PDF^182KB).

Background

In the context of assessment procedures, the Pharmacokinetics Working Party (PKWP), or its predecessor the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup), is occasionally consulted by the CHMP or, following CHMP’s agreement, by other Committees, Working parties or the CMD(h). The objective is to address specific questions in relation to pharmacokinetic evaluations and particularly the requirements and assessment of bioequivalence studies. The positions, which are being elaborated by the PKWP in response to such questions, are being forwarded to the enquiring party for consideration in their assessment.
It is understood that such position will be reflected in the procedure-related assessment reports if applicable. In some cases however, these position might also be of more general interest as they interpret a very specific aspect that would not necessarily be covered by guidelines. This paper summarises these positions which have been identified as being within this scope. In addition, general clarifications related to guidelines authored by the PKWP are subject to specific positions in this paper.
It should be noted that these positions are based on the current scientific knowledge as well as regulatory precedents. They should be read in conjunction with the applicable guidelines on bioequivalence in their current version. If the questions have initially been raised in the context of specific assessment procedures, details of these procedures have been redacted for reasons of confidentiality.
This compilation will be updated with new positions as soon as they become available. Likewise, if a position is being considered outdated, e.g. due to new evolutions in the scientific knowledge including revisions to the applicable guidelines, positions will be removed from this document. Positions previously prepared by the EWP-PK subgroup are endorsed by the current PKWP unless removed from this document.
The positions in this document are addressing very specific aspects. They should not be quoted as product-specific advice on a particular matter as this may require reflection of specific data available for this product. By no means should these positions be understood as being legally enforceable.

Topics covered are:

• Cocktail studies for investigating in vivo drug interaction potential
• Requirements for food-interaction studies for modified release formulations ^{updated 2010-07-22}
• Bioequivalence studies for paroxetine (single dose versus multiple dose studies) ^{deleted July 2010 (covered in BE-GL)}
• Interpretation of bioequivalence data in relation to both parent and metabolite PK data ^{deleted July 2010 (covered in BE-GL)}
• Bioequivalence studies in children
• Bioequivalence of gastro-resistant preparations (e.g. omeprazole) ^{updated 2010-07-22}
• Bioequivalence studies for generic products containing clopidogrel ^{updated 2010-07-22}
• Acceptance criteria for bioequivalence studies for losartan ^{new 2010-07-22}
• Bioequivalence assessment of generics for tacrolimus ^{new 2010-07-22}
• Requirements for demonstration of bioequivalence for ciclosporine generics ^{new 2010-07-22}
• Requirements for demonstration of bioequivalence for mycophenolate mofetil generics ^{new 2011-01-26}
• Recommendations on determination of absolute and relative bioavailability ^{new 2011-01-26}
• Clarification on the recommended statistical method for the analysis of a bioequivalence study ^{new 2011-01-26}