Postponed: New target date Q4 2018 [BE/BA News]

posted by Helmut Homepage – Vienna, Austria, 2018-02-15 13:04 (2558 d 02:21 ago) – Posting: # 18421
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Dear all,

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

Q4 2018 (+ one year)

Comments

This 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)

Comments

Finalise 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.
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