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Posted 24 May 2012 | By Louise Zornoza,
Brazil's national regulatory agency, Anvisa, has published a new standard (RDC 27/2012) setting forth the minimum requirements for conducting the bioanalytical method validation studies needed for the registration of medicines.
The new requirements take effect as of 1 December 2012 and will replace several provisions of Resolution 899/2003 on bioanalytical methods.
Industry may file documentation with Anvisa in accordance with the old standard or use the existing standard until 1 December 2012.
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Tags: Bioanalytic, Standard, pharmaceutical, brazil, drug
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