PharmPK Discussion - Subject Selection criteria for BE study for China

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On 1 Jan 2012 at 22:45:51, "DR.GUNA SAKARAN" (drgunasakaran.-at-.gmail.com) sent the message


Dear Mr.Narasimha,

The subject selection criteria for Bioequivalence study for China Market
as per "Chemical Bioavailability of Pharmaceutical preparations and
Biological Equivalence Technical Guidelines, March 2005 - SFDA, China"
are

1. Age : 18 - 40 years of age
2. Weight: Not less than 50 kgs

Reference: Page 15 of 30. Chemical Bioavailability of Pharmaceutical
preparations and Biological Equivalence Technical Guidelines, March 2005
- SFDA, China

Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs

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