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Revision of the BE-GL? [BE/BA News]

posted by Helmut Homepage - Vienna, Austria, 2017-04-29 15:26  - Posting: # 17280
Views: 579

Dear all,

just discovered the “Work plan for the Pharmacokinetics Working Party (PKWP) for 2017”.

2.2. EU Guidelines under revision

Guideline on the investigation of bioequivalence, CPMP/EWP/QWP/1401/98 Rev.1
Target date

Concept paper to be released for public consultation Q4 2017.

Comments

A revision will be progressed in light of experience since the previous revision and taking account of a series of Questions & Answers and ongoing related work (see below).


Guideline on the investigation of bioequivalence (Appendix 1)
Target date

Finalise the discussion with BSWP and QWP on the acceptability of the Mahalanobis distance for the similarity of dissolution profiles.

Comments

This is a joint request from the CHMP Pharmacokinetics WP and the Quality WP.


Type I error control in two-stage designs in bioequivalence studies
Target date

BSWP to provide responses to PKWP by Q2 2017.

Comments

Finalise work related to type I error control in two-stage designs in bioequivalence studies. Collaboration with the Biostatistics Working Party.


[image]All the best,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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