Bioequivalence and Bioavailability Forum

Approved Pilot and Failed Pivotal Study [Study As­sess­ment]

posted by kumarnaidu – Mumbai, India, 2015-12-08 08:02 (3847 d 04:25 ago) – Posting: # 15706
Views: 18,791

Dear all,

Recently I came across the situation where pilot study passed and pivotal study failed. The different batches of reference drug were used in both the study due to unavailability.

Pilot study (3 way reference replicate): N = 21
Cmax-99.8 (87.8 - 113.4) and AUC-99.9 (88.2 - 113.2)

Pivotal study (3 way reference replicate): N = 42
Cmax-83.3 (77.2 - 89.9) and AUC-85.2 (79.0 - 91.9)

Here I compared reference and test drug used in pilot and pivotal study

Reference
Cmax- Pivotal/Pilot = 127.2 (105.3 - 153.6)
AUC- Pivotal/Pilot = 112.5 (91.9 - 137.7)

Test
Cmax- Pivotal/Pilot = 107.2 (89.4 - 128.6)
AUC- Pivotal/Pilot = 96.7 (78.7 - 118.7)

From the above data can we say that the reference drug used in pivotal study shows more release as compared to the used in pilot study? And I think this can be the probable reason for failure of pivotal study.

Please give your suggestions.

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 Study kumarnaidu 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 Studykumarnaidu 2015-12-08 07:02