Clinical lactation studies. Acting on key recommendations over the last decade
Karen Rowland Yeo, Jacqueline Gerhart, Aarti Sawant-Basak, Francis Williams Ojara, Aida N. Kawuma, Catriona Waitt
Abstract
Including lactating women in clinical trials is imperative to generate relevant drug exposure and safety data needed to advise on clinical use of drugs in this understudied population. Recent changes in perspectives, regulatory guidance, and international networks which outline pragmatic approaches for advancing the conduct of clinical lactation studies are discussed. Case studies demonstrating successful application of modeling and simulation to complement clinical lactation data for enhanced knowledge of infant drug exposure are presented.
Topics & Concepts
LactationClinical trialComplement (music)MedicinePopulationKey (lock)Computer sciencePregnancyEnvironmental healthBiologyPathologyComputer securityComplementationGeneticsBiochemistryPhenotypeGeneBreastfeeding Practices and InfluencesNeonatal Respiratory Health ResearchPharmaceutical studies and practices