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)

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BIOANALYSIS
卷 4, 期 6, 页码 651-660

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FUTURE SCI LTD
DOI: 10.4155/BIO.12.18

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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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