Bioequivalence and Bioavailability Forum

Way to write for inclusion criteria [Regulatives / Guidelines]

posted by Ken Peh – Malaysia, 2014-04-13 06:41 (4453 d 21:13 ago) – Posting: # 12826
Views: 5,269

Dear All,

Would appreciate your input.

An example on inclusion criteria.

1. Healthy subjects, 18-55 years of age.
   
2. Healthy male and female subjects, 18-55 years of age.

In (I), either sexes or both sexes can be used. In the event that we are not able to recruit or enroll female subjects, we can enroll 100% male subjects and the study can still proceed.

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

What should be the right approach ? Is it essential to provide detailed information in BE study protocol ? If we only recruit male subjects, we need to write healthy male subjects ?

Thank you.

Regards,
Ken

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Please don’t write “RE: ” in the subject line; removed. [Helmut]

Complete thread:

• Way to write for inclusion criteriaKen Peh 2014-04-13 04:41 
  • Way to write for inclusion criteria ElMaestro 2014-04-13 09:52
  • Way to write for inclusion criteria Ohlbe 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