M10: bioanalytical method validation and study sample analysis : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Chemistry Techniques, Analytical Government Regulation Methods United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. Adherence to the principles presented in this guidance will ensure the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs. The objective of the validation of a bioanalytical method is to demonstrate that it is suitable for its intended purpose. You may use an alternative approach from the recommendations in this guidance if it satisfies the requirements of applicable statutes and regulations. Alternative approaches should be supported by appropriate scientific justification. Applicants are encouraged to consult the regulatory authority(ies) regarding significant changes in method validation approaches when an alternate approach is proposed or taken. This guidance replaces the ICH draft guidance for industry M10 Bioanalytical Method Validation, issued on June 27, 2019.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 50 pages))
- NLM Unique ID:
- 9918590087306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590087306676