title: Models and methods for predicting drug transfer into human milk.
abstract: Adverse effects in infants due to the ingestion of drugs and other xenobiotics remain an area of concern. A key parameter in assessing infant exposure via breast milk, the milk to plasma concentration ratio (M/P), has not been determined in vivo in humans for most drugs. There are various methods for predicting M/P, which involve in vitro experiments in mammary cell monolayers, assessment of drug binding to plasma and milk protein and lipid, in vivo experiments in animals, and regression models based on a compound's physicochemical characteristics. This article reviews these approaches in terms of their utility, advantages and disadvantages. Some combination of these methods is necessary for reasonably accurate prediction of M/P in humans.
authors.affiliation: Clinical Pharmacology, Pharmacia 7215-24-205, 301 Henrietta Street, Kalamazoo, MI 49007, USA. joseph.c.fleishaker@pharmacia.com
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Fleishaker
mesh_terms: D000818:Animals; D005260:Female; D006801:Humans; D066298:In Vitro Techniques; D007223:Infant; D008321:Mammary Glands, Animal / Q000378:metabolism / Q000502:physiology; D042361:Mammary Glands, Human / Q000378:metabolism / Q000502:physiology; D008892:Milk / Q000378:metabolism; D008895:Milk, Human / Q000378:metabolism*; D023421:Models, Animal; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D010599:Pharmacokinetics; D012044:Regression Analysis
chemical_list: D004364:Pharmaceutical Preparations