calculation of Washout period [Regulatives / Guidelines]

posted by drgunasakaran1  – 2014-01-17 18:59 (4548 d 01:35 ago) – Posting: # 12191
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Dear Mr Mahesh,

❝ EMA recommended 10 times t 1/2.


As per EMA BE Guidance "Normally at least 5 elimination half-lives should be provided as Wash out period"
Canadian Guidance states that washout period should be not less than 10 times the mean terminal half-life of the drug.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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