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GUIDANCE DOCUMENT

M10 BIOANALYTICAL METHOD VALIDATION June 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
2019-13698
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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-13698 .