4.3 Article

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)

Journal

BIOANALYSIS
Volume 4, Issue 6, Pages 651-660

Publisher

FUTURE SCI LTD
DOI: 10.4155/BIO.12.18

Keywords

European Medicines Agency; EMA; FDA; matrix selection; reference standards; stability

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These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.

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