Bioequivalence and Bioavailability Forum

Housing of male and female volunteers in BABE [Regulatives / Guidelines]

posted by bharat – India, 2010-03-09 07:57 (5957 d 20:23 ago) – Posting: # 4878
Views: 4,025

Dear Rohit

❝ In BA/BE facility up, if male and female volunteer together study to be conducted;

❝ Q1] is their any specific guidance which defines regarding the housing?

Yes,there is specific guidance which defines regarding the housing which is generally 10 hrs for all submission except ANVISA, it doesn't matter if you included female or male.

❝ Q2] If in the facility, apart from the housing area other area can used for the housing which is part of facility ? Can there be any regulatory concerns?

There will not be any regulatory concern, but logically housing area will be CPU

Regards,

Bharat Narnavar

Complete thread:

• Housing of male and female volunteers in BABE Rohit 2010-02-23 14:59 
  • Housing of male and female volunteers in BABEbharat 2010-03-09 06:57
    • Stat Analysis of male and female volunteers in BABE MGR 2012-01-05 14:09
      • FDA & ANVISA Helmut 2012-01-05 20:01
      • Stat Analysis of male and female volunteers in BABE ElMaestro 2012-01-05 20:19