S5(R3) detection of reproductive and developmental toxicity for human pharmaceuticals
- 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 Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug-Related Side Effects and Adverse Reactions Reproductive Physiological Phenomena -- drug effects Toxicity Tests United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- The purpose of this guidance is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART) testing necessary to support human clinical trials and marketing authorization for pharmaceuticals. The guidance describes potential strategies and study designs to supplement available data to identify, assess, and convey risk. General concepts and recommendations are also provided that should be considered when interpreting study data. This guidance revises the ICH guidance S5 Detection of Toxicity to Reproduction for Medicinal Products (September 1994). This revision brings the guidance into alignment with other ICH guidances, elaborates on the use of exposure margins in dose-level selection, incorporates a section on risk assessment, and expands the scope to include vaccines and biopharmaceuticals. It also describes qualification of alternative assays, describes potential scenarios of use, and provides options for deferral of developmental toxicity studies.
- 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, 116 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918350987506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350987506676