Bioequivalence and Bioavailability Forum • Truncated 72 hours

Truncated 72 hours [NCA / SHAM]

posted by mmw – India, 2015-02-09 12:12 (3356 d 03:13 ago) – Posting: # 14389
Views: 9,926

Dear All,

We have conducted a truncated bio-equivalence study (truncation up to 72 hours as per European GL requirements). But it was found that around one-third of the study population did not turn up for 72.00 hours ambulatory sample.

Is their any impact on calculation of AUC due to number of missed sample? Could these subjects be excluded from statistical analysis? If yes, on what basis we exclude these subjects? However, this was not mentioned anywhere in guideline regarding exclusion of such subjects in truncated studies?

Thanks

MMW

Edit: Category changed. [Helmut]

Complete thread:

Truncated 72 hoursmmw 2015-02-09 11:12 [NCA / SHAM]
- Truncated 72 hours Dr_Dan 2015-02-09 12:59
- Truncated 72 hours Helmut 2015-02-09 16:10
  - Truncated 72 hours nobody 2015-02-09 22:48
    - Truncated 72 hours mmw 2015-02-11 12:57
  - Truncated 72 hours stic-stats 2020-07-13 14:22
    - Truncated 72 hours Helmut 2020-07-13 17:07
      - Truncated 72 hours stic-stats 2020-07-15 06:17
  - Truncated 72 hours M.tareq 2020-07-16 01:36
    - Truncated 72 hours Helmut 2020-07-16 11:56
      - Truncated 72 hours M.tareq 2020-07-16 17:05
        
        PK modeling in BE Helmut 2020-07-16 18:30
        
        PK modeling in BE mittyri 2020-07-19 00:24
        
        PK modeling in BE Helmut 2020-07-19 12:35