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RegisterPostponed: New target date Q4 2018 [BE/BA News]
posted by Helmut 
– Vienna, Austria, 2018-02-15 13:04 (2642 d 23:33 ago) – Posting: # 18421
Views: 5,213
Guideline on the investigation of bioequivalence (Appendix 1)
Target date
Q4 2018 (+ one year)
CommentsThis is a joint request from the CHMP Pharmacokinetics WP and the Quality WP. Following the publication of the Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development, finalise the discussion with PKWP and QWP on the acceptability of the Mahalanobis distance for the similarity of dissolution profiles. The final output may be included in the aforementioned Reflection Paper or may form a Q&A.
Type I error control in two-stage designs in bioequivalence studies
Target date
Q4 2018 (+ 1½ years)
CommentsFinalise on-going discussion related to type I error in two-stage design bioequivalence studies. The final output will most likely form a Q&A (to be confirmed).
Sources: Work plan for the Pharmacokinetics Working Party (PKWP) for 2018, Work plan for the Biostatistics Working Party (BSWP) for 2018.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ...and much more ElMaestro 2017-04-29 15:58
- Postponed: New target date Q4 2018Helmut 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
Ing. Helmut Schütz