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S11 nonclinical safety testing in support of development of pediatric pharmaceuticals
S11 nonclinical safety testing in support of development of pediatric 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 Compounding
Drug Industry
Pediatrics
Pharmaceutical Preparations
Quality Control
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 document is to recommend international standards for, and promote harmonisation of, the nonclinical safety assessments to support the development of pharmaceuticals intended for pediatric use. Harmonisation of the guidance for nonclinical safety studies will define the current recommendations and reduce the likelihood that substantial differences will exist among regions. It should facilitate the timely conduct of pediatric clinical trials and reduce the use of animals in accordance with the 3R (replace/reduce/refine) principles. Guidances have previously been issued by various regulatory agencies and are not in complete agreement on whether a juvenile animal study (JAS) is advisable and its timing and design. This guidance is intended to complement and expand on existing ICH guideances (e.g., ICH E11, M3, S5 and S9) and reflects current thinking based on collations of examples by regulatory agencies, by industry surveys, and literature. This guidance recommends an approach for the nonclinical safety evaluation of pharmaceuticals intended for development in pediatric populations. This can include products with prior adult use, as well as products being considered for initial human use in pediatrics (see section IV (4)). The ICH S9 guidance should be consulted for recommendations on whether to conduct a JAS for those pharmaceuticals included in the scope of the ICH S9 guidance, i.e., anticancer pharmaceuticals. The ICH S11 guidance should be consulted for study design in all cases, including oncology indications. Small molecule therapeutics and biotechnology-derived pharmaceuticals as defined in ICH S6 are within the scope of this guidance. Tissue engineered products, gene and cellular therapies, and vaccines are excluded from the scope of this guidance because dedicated juvenile animal safety studies are generally not warranted for such products. However, some of the thinking outlined in this document about evaluating safety with existing information can apply.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 44 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 9918350987106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350987106676