Optimizing Maternal and Fetal Antibody Exposure and Dosing Regimens During Pregnancy Using a Physiologically Based Pharmacokinetic Model

• Published in: Clinical pharmacology and therapeutics Vol. 118; no. 2; p. 394
• Main Authors: Kardouh, Miramar Sami, Dunlap, Tyler C, Zhong, Rui, Tiley, Jacqueline B, Cao, Yanguang
• Format: Journal Article
• Language: English
• Published: United States 01.08.2025
• Subjects: Adult; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - pharmacokinetics; Female; Fetus - metabolism; Histocompatibility Antigens Class I - metabolism; Humans; Immunoglobulin G; Infant, Newborn; Maternal-Fetal Exchange; Models, Biological; Placenta - metabolism; Pregnancy; Receptors, Fc - metabolism

Therapeutic antibodies are often prescribed off-label to pregnant patients to treat inflammatory, autoimmune, or malignant conditions. Despite their broad use, the extent of fetal exposure to such therapeutic antibodies and the risk to fetal development remain largely unknown. Given the ethical chal...