Dr sridevi
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India,
2013-06-18 16:51
(4754 d 17:58 ago)

Posting: # 10809
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 Bioanalytical Methods [Regulatives / Guidelines]

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Is it necessary to have method development and full validation report before intiation of study for ANVISA submission
 
drgunasakaran1
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2013-06-18 19:27
(4754 d 15:22 ago)

@ Dr sridevi
Posting: # 10812
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 Bioanalytical Methods

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❝ Is it necessary to have method development and full validation report before intiation of study for ANVISA submission


Dear Dr Sridevi,

Kindly follow the Forum Policy, see here

As per ANVISA regulatory requirements, it is not mandatory to have method development and full validation report in place before the initiation of the study.
—
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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