Model-informed Drug Development Enhancing Clinical Lactation Studies:
Model-informed drug development (MIDD) is increasingly adopted to support global health equity by providing guidance on the safe use of medications in lactating women and their nursing infants. In this webinar, we explore how MIDD enhances clinical lactation studies to support more informed decision-making regarding the safety of administering medication to lactating mothers.
Key Takeaways:
Global health impact: MIDD can enhance global health equity by helping optimize clinical study design to make the most of scarce funding, and to extrapolate data from studied to unstudied scenarios.
Specific population considerations: Special attention is needed for underserved populations such as lactating women and neonates who are frequently excluded from clinical studies due to safety concerns. Modeling approaches like PBPK and PopPK help estimate drug exposure and hence assess predicted safety , supporting evidence-based study design and drug dosing considerations.
Policy implications: Quantitative guidance, informed by both clinical data and predictive modeling, can assist with decision-making about the restrictions on primaquine use in lactating women, reducing the risk of recurrent malaria for mothers caring for their infants, and strengthening global malaria control strategies.
Relevance to drug development: Considering the increased call for drug developers to take into account the unique physiology of children, and pregnant and lactating women early in drug development, the strategy described here (clinical lactation study complemented by modeling) can be instrumental in the industry setting.
演讲嘉宾：
- Karen Rowland-Yeo, PhD, SVP, Client & Regulatory Strategy, Certara
- Joel Tarning, PhD, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Oxford University, Oxford, UK
- Mellie Gilder, MD, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, Oxford University, Oxford, UK
- Nada Abla Geiser, PharmD, PhD, Director, Drug Disposition & PBPK Modeling, Medicines for Malaria Venture
