New product-specific bioequivalence guidance

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Abstract

For harmonization of the authorization requirements for specific generic applications within the EU, consistent criteria were drafted for 16 active substances, which are out now for public consultation.

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APA

Baumgärtel, C. (2014). New product-specific bioequivalence guidance. GaBI Journal, 3(1), 29–29. https://doi.org/10.5639/gabij.2014.0301.009

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