Bioanalytical method validation
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Evaluation, Preclinical -- standards Reproducibility of Results Research Design -- standards Validation Studies as Topic Biomarkers Documentation Dried Blood Spot Testing -- standards Investigational New Drug Application Quality Control Reagent Kits, Diagnostic -- standards Sensitivity and Specificity Specimen Handling -- standards Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Guideline Technical Report
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (41 pages)).
- NLM Unique ID:
- 101734209 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101734209