All about bioanalysis

The FDA has issued a Guidance for Industry entitled “Bioanalytical Method Validation”. This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods.  Bioanalytical methods provide critical data to support the safety and efficacy of drugs and biologic products. The final guidance describes the (...)

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Over the past 25 years the criteria required for bioanalytical methods has evolved significantly. The harmonization of bioanalytical methods requirements started in 1990 during the AAPS and FDA Crystal City Meetings. In 2000 the Crystal City II Meeting laid the foundations of the 2001 FDA Guidance on Bioanalytical Method Validation. In 2011 EMA launched his (...)

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