Pre dose concentration [Regulatives / Guidelines]

posted by drgunasakaran1  – 2012-02-28 12:36 (4412 d 19:47 ago) – Posting: # 8174
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Dear Mr.Auditor,

As per FDA's Individual Product Bioequivalence Recommendation for Ergocalciferol, an endogenous substance, any subject with pre-dose concentration more than 5% of their Cmax should be excluded from BE statistical analysis.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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