24th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry
London, UK
Jun Guo
Shanghai Institute for Biomedical and Pharmaceutical Technologies, China
Title: Exploring the relevance and considerations of implementing alternative approaches to the assessment of reproductive and developmental toxicity of pharmaceuticals under ICH S5(R3)
Biography
Biography: Jun Guo
Abstract
The 3Rs principle (Replace, Reduce and Refine) and the ICH S5 (R3) guideline have globally advanced alternative methods for reproductive and developmental toxicity assessment. These developments bring about stringent requirements and challenges. Reproductive and developmental toxicity assessment is complex, and current alternatives don't fully replicate in vivo drug actions, impacting sexual maturation, fertilization, gametogenesis, syncytial development, postnatal maturation and sexual functionality.
ICH S5 (R3) promotes reducing animal use without compromising risk assessment quality, emphasizing justification for including alternative tests in the strategy, adherence to Good Laboratory Practice (GLP), and evaluation of drug metabolite effects following ICH M3 guidelines. The guideline doesn't prescribe specific methods but demands rigorous method validation and lists 29 reference compounds causing maternal embryofetal lethality (MEFL) in non-clinical or human studies with minimal maternal toxicity. Test endpoints should align with objectives and predictive capabilities.