ICH
has published a new document: “Guideline on reproductive toxicology: Detection
of Toxicity to Reproduction for Human Pharmaceuticals” [ICH S5 (R3)]
The
purpose of this document is to recommend international standards for, and
promote harmonization of, the assessment of nonclinical developmental and
reproductive toxicity (DART) testing required to support human clinical trials
and marketing authorization for pharmaceuticals. The guideline 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 is a revision of the ICH guideline “S5 Detection
of Toxicity to Reproduction for Medicinal Products” that was originally
published in 1993. This revision brings the guideline into alignment with other
ICH guidelines, 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, potential scenarios of use, and provides options for
deferral of developmental toxicity studies. To assess a human pharmaceutical’s
effect on reproduction and development, there should generally be information
available that addresses the potential impact of exposure to a pharmaceutical
and, when appropriate, its metabolites (ICH M3, ICH S6) on all stages of
reproduction and development.
This
document comes into effect in the EU on 30 July 2020
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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