Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine

• André Dallmann,
• Peter L. Bonate,
• Janelle Burnham,
• Blessy George,
• Lynne Yao,
• Jane Knöchel

Affiliations

André Dallmann

Bayer HealthCare SAS, Lille, France, on behalf of: Pharmacometrics/Modeling & Simulation, Research & Development, Pharmaceuticals Bayer AG Leverkusen Germany

Peter L. Bonate

Early Development, New Technologies Group Astellas Northbrook Illinois USA

Janelle Burnham

Global Product Development, Clinical Development and Operations Pfizer Inc New York New York USA

Blessy George

Division of Pharmacology‐Toxicology for Immunology and Inflammation, Office of Immunology and Inflammation, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Lynne Yao

Division of Pediatrics and Maternal Health, Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Jane Knöchel

Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D AstraZeneca Gothenburg Sweden