title: Pharmacokinetic Considerations in Designing Pediatric Studies of Proteins, Antibodies, and Plasma-Derived Products.
abstract: Ignoring the principles of pediatric pharmacology can have serious consequences. Therefore, it is necessary to understand and recognize the impact of developmental processes in children. It is now well recognized that age and the disease state can alter the pharmacokinetics (PKs) of a drug, as a result adjustment in dosing regimen in children as compared with the adults is essential. This review emphasizes on the importance of PK studies in pediatric population for macromolecules. Macromolecules differ from small molecules in many respects, and it is necessary to have a thorough understanding of the behavior of macromolecules in the body across different age groups. The review highlights that like small molecules, the PKs of macromolecules in pediatric population also differ from adults, hence, a PK study is essential in pediatrics for appropriate dose selection in this population. The review also takes a critical look on the many extrapolation techniques to predict PK parameters in pediatrics from adult data.
authors.affiliation: Division of Hematology, Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Mahmood
mesh_terms: D000367:Age Factors; D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics*; D001499:Bayes Theorem; D001688:Biological Products / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D004705:Endocytosis / Q000502:physiology; D006207:Half-Life; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007668:Kidney / Q000378:metabolism; D008099:Liver / Q000378:metabolism; D008657:Metabolic Clearance Rate; D010949:Plasma; D011506:Proteins / Q000493:pharmacokinetics*; D012107:Research Design
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D011506:Proteins