Papers

Recommendations on the Interpretation of the new EMA Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis

Published by GCC

Introduction
Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. 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.

Click for full article

Subscribe for updates

EXPLORE OUR BIOANALYTICAL PLATFORMS

See how we apply our specialized large molecule expertise to help solve your bioanalytical challenges.


View Services

Analytical Assays Determine Biosimilar Product Quality

READ THE ARTICLE

Pharmacokinetics & Pharmacodynamics​

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.
220328 Adleverage_Scientific Icon Illustrations_#46-65_CO_Per FIles