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

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

posted by sandipmumbai – India, 2013-02-26 12:03 (4872 d 16:07 ago) – Posting: # 10120
Views: 4,529

Hi Helmut,

I have one query regarding partial replicate study design.
We used partial replicate study design (TRT, RTR, RRT), if any subject completed two periods of the study and having reference in both periods.

Therefore, we have to considered this subject for calculation of Swr (Standard deviation within referene product) or we do not have to analyze this subjects.

Plz opion.

Thanks & Regards,

Sandy

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