Bioequivalence and Bioavailability Forum • Statistics in multiple dose study

Statistics in multiple dose study [NCA / SHAM]

posted by ratnakar1811 – India, 2009-12-03 08:36 (5617 d 20:27 ago) – Posting: # 4408
Views: 11,595

Dear HS,
Many thanks for your prompt reply!

We are doing this study as a multiple dose just because single dose Nasal spray dose not give detectable concentrations. Now is it necessary that we have to prove Steady state in such situations also? If yes, then we will have to follow the all steady state requirements.

Secondly for other parameters such as %fluctuations and Cmin criteria of 80-125% CI required to be applied or not? Cav should also be analysed with confidence interval or not?

Thanking you in advance!

Ratnakar

Complete thread:

Statistics in multiple dose study ratnakar1811 2009-12-01 11:09 [NCA / SHAM]
- Statistics in multiple dose study Helmut 2009-12-02 00:20
  - Statistics in multiple dose studyratnakar1811 2009-12-03 07:36
    - Statistics in multiple dose study Helmut 2009-12-03 14:53
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