Bioequivalence and Bioavailability Forum • Partial Replicate Study Design (subjects considered for PK)

Partial Replicate Study Design (subjects considered for PK) [Regulatives / Guidelines]

posted by Dr_Dan – Germany, 2013-02-26 14:08 (4873 d 05:51 ago) – Posting: # 10121
Views: 3,782

Dear Sandy
It is always a bad idea to remove data from a data set, assessors do not like this. If a subject completed two periods and both of them with the reference treatment, then of course you can not use this subject for the comparison between test and reference but you could (and should) use this subject to calculate the within subject variability of the reference drug product.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

Partial Replicate Study Design (subjects considered for PK) sandipmumbai 2013-02-26 11:03
- Partial Replicate Study Design (subjects considered for PK)Dr_Dan 2013-02-26 13:08
- Partial Replicate Study Design (subjects considered for PK) Ohlbe 2013-02-26 13:29
- incomplete data (without T) Helmut 2013-02-26 14:38
  - incomplete data (without T) sandipmumbai 2013-02-27 07:29