Bioequivalence and Bioavailability Forum

Dear Forum Members,

Anybody has experience of conducting study for Medroxyprogesterone 150 mg IM injection?

As per WHO around 124 subjects are required and a possible sampling scheme could be: pre-injection, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14, 16, 18, 21, 24, 28, 35, 49, 63, 77, 91, 105, 119, 140 days.

From the above mentioned sampling scheme which is suggested in days, it is difficult to understand from which time point samples are to be collected in days? Is it from 28? Further do you feel looking at the PK data (linked with FDA, page 10) it seems sampling points suggested by WHO are inadequate?

In addition to it study with USFDA where following sampling schedule was followed it seems over sampling is done that too in females:
0, 0.5, 1,2,3,4,6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240,264, 288, 312, 360, 432, 504, 576, 648, 816, 984, 1154, 1320, 1488, 1656, 1824, 1992, 2164, 2328, 2496, 2664, 2856 hrs.

The PK data can be found (on page 10)

Your valuable suggestions and comments are highly appreciated.

Thanking you,

Ratnakar