Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report.

This report summarizes the proceedings for Day 3 of the workshop titled "". This day focused on the current and future drug product quality applications of PBBM from the innovator and generic industries as well as the regulatory agencies perspectives. The presentations, which included several case studies, covered the applications of PBBM in generic drug product development, applications of virtual bioequivalence trials to support formulation bridging and the utility of absorption modeling in clinical pharmacology assessments.

Early postnatal effects of maternal obesity on breast milk composition and breastfeeding outcomes.

Background & Aims: Breastfeeding can be challenging in mothers with overweight or obesity-related chronic low-grade inflammation, resulting in negative consequences for the newborn. The pre-gestational body mass index is negatively associated with lactogenesis II, the onset of colostrum secretion. Herein, we evaluated mothers' inflammation, metabolic status, and components of breast milk after birth to associate these factors with their nutritional and breastfeeding status.