calculation of Washout period [Regulatives / Guidelines]
Dear Mr Mahesh,
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.
❝ 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
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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