Transfer of the Dual Orexin Receptor Antagonist Daridorexant into Breast Milk of Healthy Lactating Women

P Kaufmann, C Muehlan, M Anliker‐Ort… - The Journal of …, 2024 - Wiley Online Library
The novel dual orexin receptor antagonist daridorexant was approved in 2022 for the
treatment of adult patients with insomnia. The aim of this post‐marketing study was to …

Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations

SC Nallani, K Baisden, M Dinatale… - The Journal of …, 2023 - Wiley Online Library
The availability of clinical pharmacology and safety data regarding the use of prescription
medications in pregnant and lactating individuals has been historically limited, despite …

Dose Optimization Informed by PBPK Modeling: State‐of‐the Art and Future

K Rowland Yeo, E Gil Berglund, Y Chen - Clinical Pharmacology & … - Wiley Online Library
Model‐informed drug development (MIDD) is a powerful quantitative approach that plays an
integral role in drug development and regulatory review. While applied throughout the life …