Bioequivalence and Bioavailability Forum

Study population [Design Issues]

posted by avrahan – 2014-10-20 17:17 (3468 d 19:05 ago) – Posting: # 13758
Views: 2,928

Dear All

I would like to perform a BE study for a drug indicated to:

1. Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets.
   
2. Also indicated for use in secondary amenorrhea.

In this case should I recruit females with postmenopausal condition or no restriction should be done?

Thanks for your reply.

Regards

Complete thread:

• Study populationavrahan 2014-10-20 15:17 [Design Issues] 
  • Study population nobody 2014-10-21 12:22