Revision of the BE-GL? [BE/BA News]
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.
CommentsA 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.
CommentsThis 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.
CommentsFinalise work related to type I error control in two-stage designs in bioequivalence studies. Collaboration with the Biostatistics Working Party.
- The EMA doesn’t maintain a version control system (previous versions are overwritten by new ones). This is the archived document at web.archive.org.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Revision of the BE-GL?Helmut 2017-04-29 15:26 [BE/BA News]
- ...and much more ElMaestro 2017-04-29 15:58
- Postponed: New target date Q4 2018 Helmut 2018-02-15 12:04
- Postboned: New target date Q4 2018 nobody 2018-02-15 12:24
- Postponed: New target date Q4 2018 Helmut 2018-02-15 13:32
- Postboned: New target date Q4 2018 nobody 2018-02-15 12:24