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Back to the forum  Query: 2017-11-24 06:48 CET (UTC+1h)
Vienna, Austria,
2017-04-29 15:26

Posting: # 17280
Views: 809

 Revision of the BE-GL? [BE/BA News]

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.


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.


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.


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

Helmut Schütz 

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

2017-04-29 15:58

@ Helmut
Posting: # 17281
Views: 667

 ...and much more

Hi Hötzi,

yes, and there's no doubt there's going to be lots of interesting news in the coming years.
There's a WP dedicated to M&S which is picking up speed (there wouldn't be one if the general attitude towards M&S was entirely negative, would there?!?), and the OIP guideline from 2009 is also under revision which will create obstacles for some and pave ways forward for others.

And I was asked yesterday by an agency employee if we need a dedicated data integrity guideline and/or WP. I think this question was posed in view of the recent horror stories about BE CROs.

I could be wrong, but…

Best regards,

No, I still don't believe much in the usefulness of IVIVCs for OIPs when it comes to picking candidate formulations for the next trial. This is not the same as saying I don't believe in IVIVCs.
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seems to me the deepest root of all
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BEBAC Ing. Helmut Schütz