In Part 1, we provided a general description of macromolecules, pharmacokinetics (PK) characteristics in non-pregnant subjects, and the physiological changes during pregnancy. Here we further elaborate on the impact of pregnancy on the PK of antibodies through illustrative case studies (immunoglobulins, infliximab, adalimumab and eculizumab). Using published data from nonclinical and clinical studies, we present measured or calculated PK parameters from pregnant subjects comparing with data from non-pregnant subjects, if available. Due to the paucity of PK data evaluating PK of antibodies during pregnancy, we also provide examples of PK studies for small molecules. Finally, we draw conclusions on the nature and direction of PK changes for both antibodies and small molecules as well as provide recommendations for areas that would benefit from further studies.
Keywords: Exposure; Macromolecules; Pharmacokinetics; Physiology; Pregnancy.
Published by Elsevier B.V.