Bioequivalence and Bioavailability Forum • Way to write for inclusion criteria

Way to write for inclusion criteria [Regulatives / Guidelines]

posted by Ohlbe – France, 2014-04-13 14:31 (4458 d 05:52 ago) – Posting: # 12830
Views: 4,578

Dear Ken,

If you plan to only have male subjects in the study, I think you should write it clearly in the protocol.

❝ In (II), both male and female must be recruited and enrolled.

Yes, I think it could be interpreted that way. If the study is for FDA submission that's what they would expect anyway. In the EU male-only studies are accepted (and actually common practice).

❝ I. Healthy subjects, 18-55 years of age.

May be safer if you're not sure to be able to get females too.

—
Regards
Ohlbe

Complete thread:

Way to write for inclusion criteria Ken Peh 2014-04-13 04:41
- Way to write for inclusion criteria ElMaestro 2014-04-13 09:52
- Way to write for inclusion criteriaOhlbe 2014-04-13 12:31
  - Way to write for inclusion criteria Ken Peh 2014-04-14 06:12
    - Way to write for inclusion criteria kvgreddy06 2014-04-14 13:01
    - Way to write for inclusion criteria jag009 2014-04-14 15:40
      - ♀/♂-ratio Helmut 2014-04-15 13:50
        
        ♀/♂-ratio lechia 2014-04-24 17:00
- Way to write for inclusion criteria Mahesh M 2014-04-14 14:06