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ANVISA guidance [Regulatives / Guidelines]

posted by Priyanka_S – 2010-03-20 12:09 (5542 d 22:13 ago) – Posting: # 4945
Views: 4,766

Dear HS,

For ANVISA submission, If more than 10% of samples (plasma concentrations) are missing in one period then do we need to give the the BE result both including & excluding that subject?

—
Best Regards

Priyanka S

Complete thread:

ANVISA guidancePriyanka_S 2010-03-20 11:09 [Regulatives / Guidelines]
- ANVISA guidance bharat 2010-03-22 10:40
- ANVISA guidance Dr_Dan 2010-04-01 15:34
  - Bioanalysis of dropouts, etc. Helmut 2010-04-01 15:56

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Pharmacokinetics may be simply defined as
what the body does to the drug,
as opposed to pharmacodynamics, which may be defined as
what the drug does to the body. Leslie Z. Benet

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