Anvisa Updates BA, BE Test Best Practices Certification

Regulatory NewsRegulatory News | 10 October 2014 |  By 

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Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. 

The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharmacokinetic and pharmacodynamics parameters between a test product and its reference drug or comparator—are conducted correctly and to Brazilian regulatory standards.

One of the changes on the new certification is the validity period, which was changed to two years from the expiration of the previous certificate.  BA/BE for registration and post-registration of medicines are also required to be performed in certified test centers.



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