Bioequivalence and Bioavailability Forum • Narrow Therapeutic statistics

Narrow Therapeutic statistics [Regulatives / Guidelines]

posted by hiren379 – India, 2012-07-11 08:17 (5099 d 22:38 ago) – Posting: # 8921
Views: 5,276

Hello,
I think you can try below approaches

1) Go for Wilcoxon for Tmax----if results come in yr favour, u can further justify otherwise yr battle is lost

2) Next, if step 1 is in yr favour. You can clinically justify using literature that Tmax observed is clinically not significant (Strong justification will be required)

3) Can assess individual and population BE as per USFDA and give supportive evidance

All the best...

Complete thread:

Narrow Therapeutic statistics Compliance 2012-07-09 07:13
- Narrow Therapeutic statisticshiren379 2012-07-11 06:17
  - Narrow Therapeutic statistics Compliance 2012-07-11 06:29
    - Narrow Therapeutic statistics hiren379 2012-07-11 08:59
  - Tmax required for the FDA? Helmut 2012-07-11 15:59
- Narrow Therapeutic statistics kumarnaidu 2013-04-10 10:27
  - Power? d_labes 2013-04-10 10:38
- Narrow Therapeutic statistics kvgreddy06 2014-09-01 17:13
  - Narrow Therapeutic statistics Compliance 2014-09-10 12:07