Therapeutic ReviewsPharmacokinetic Considerations in Designing Pediatric Studies of Proteins, Antibodies, and Plasma-Derived ProductsMahmood, Iftekhar PhDAuthor Information Division of Hematology, Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD. *Address for correspondence: Division of Hematology, Office of Blood Review and Research, Center for Biologic Evaluation and Research, Food and Drug Administration, Rockville, MD. E-mail: [email protected] The author has no funding or conflicts of interest to disclose. The views expressed in this article are those of the author and do not reflect the official policy of the FDA. No official support or endorsement by the FDA is intended or should be inferred. American Journal of Therapeutics: July/August 2016 - Volume 23 - Issue 4 - p e1043-e1056 doi: 10.1097/01.mjt.0000489921.28180.b9 Buy Metrics 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. Copyright © 2012 Wolters Kluwer Health, Inc. All rights reserved.