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GUIDANCE DOCUMENT

M10 BIOANALYTICAL METHOD VALIDATION June 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-1469
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples. Adherence to the principles presented in this guideline will improve the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-1469.

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