1. EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.
- Author
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Manolis, Efthymios, Musuamba, Flora Tshinanu, Vries, Corinne S., Colin, Pieter J., and Oleksiewicz, Martin B.
- Subjects
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PREGNANT women , *BREASTFEEDING , *PREGNANCY outcomes , *UNPLANNED pregnancy , *ACTIVE biological transport , *COMPUTER software industry - Abstract
This article discusses the need for improved labeling recommendations for medications used during pregnancy and breastfeeding. Currently, there is a lack of data on the safety and efficacy of drugs for these populations, as they are often excluded from drug development programs. The article highlights the value of Model Informed Drug Development (MIDD) in generating data and improving accessibility to safe and effective medicines. Regulatory developments and advancements in nonclinical drug development methodologies and MIDD are expected to enhance the safe use of medicines during pregnancy and breastfeeding. However, challenges remain, including limited experience with MIDD in this context and the uncertainty associated with model predictions. Efforts are being made to improve knowledge through data collection and the development of new methods. European regulators are open to discussions to improve labeling for medicines used during pregnancy and breastfeeding. [Extracted from the article]
- Published
- 2024
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