Bioequivalence and Bioavailability Forum

Approved Pilot and Failed Pivotal Study [Study Assessment]

posted by kumarnaidu – Mumbai, India, 2014-03-18 06:03 (4486 d 16:21 ago) – Posting: # 12642
Views: 20,920

Hi all,
In this case reference drug itself behaving as a variable drug. Also the inrasubject CV was also > 30%. According to me one should go for the replicate design (reference replicate)in pivotal study. Lets take other members opinion.

—
Kumar Naidu

Complete thread:

Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 15:27 [Study Assessment]
- Approved Pilot and Failed Pivotal Study nobody 2014-03-17 16:02
  - Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 17:51
    - Approved Pilot and Failed Pivotal Study nobody 2014-03-17 18:38
      - Approved Pilot and Failed Pivotal Study Lucas 2014-03-17 18:55
        
        Approved Pilot and Failed Pivotal Studykumarnaidu 2014-03-18 05:03
    - Approved Pilot and Failed Pivotal Study - same test? Dr_Dan 2014-03-18 11:30
      - Approved Pilot and Failed Pivotal Study - same test? Lucas 2014-03-18 13:38
- Approved Pilot and Failed Pivotal Study Tina 2014-03-18 10:28
  - Approved Pilot and Failed Pivotal Study Ohlbe 2014-03-18 11:15
  - Approved Pilot and Failed Pivotal Study Helmut 2014-03-18 13:06
    - Approved Pilot and Failed Pivotal Study Tina 2014-03-18 13:24
      - Approved Pilot and Failed Pivotal Study nobody 2014-03-18 13:31
        
        Approved Pilot and Failed Pivotal Study Lucas 2014-03-18 14:03
        
        Approved Pilot and Failed Pivotal Study nobody 2014-03-18 15:55
        Approved Pilot and Failed Pivotal Study luvblooms 2014-03-19 05:16
        
        Approved Pilot and Failed Pivotal Study kumarnaidu 2015-12-08 07:02

Approved Pilot and Failed Pivotal Study [Study As­sess­ment]

Complete thread:

Approved Pilot and Failed Pivotal Study [Study Assessment]