Ethnicity of Indian population [Regulatives / Guidelines]

posted by Achievwin – US, 2021-07-06 16:21 (448 d 16:12 ago) – Posting: # 22461
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» What is the Ethnicity of Indian population, for Bioequivalence study subjects.

In the demographics tables for FDA we are required to provide Race and Ethnicity in two different categories.

For Race: It is Asian (to be precise Asiatic Indians)
For Ethnicity: is Non-Hispanic non Latino or simply others (danger: you may have others 100% for studies using Indian BE studies)

Hope this helps,

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