This study aimed to determine the effects of pregnancy and ontogeny on risperidone and paliperidone pharmacokinetics by assessing their serum concentrations in two subjects and constructing a customized physiologically‐based pharmacokinetic (PBPK) model. Risperidone and paliperidone serum concentrations were determined in a pregnant woman and her newborn. PBPK models for risperidone and paliperidone in adults, pediatric, and pregnant populations were developed and verified using the Simcyp simulator. These models were then applied to our two subjects, generating their “virtual twins.” Effects of pregnancy on both drugs were examined using models with fixed pharmacokinetic parameters. In the neonatal PBPK simulation, 10 different models for estimating the renal function of neonates were evaluated. Risperidone was not detected in the serum of both pregnant woman and her newborn …
Research Authors
Walaa YB Mahdy, Kazuhiro Yamamoto, Takahiro Ito, Naoko Fujiwara, Kazumichi Fujioka, Tadasu Horai, Ikuo Otsuka, Hitomi Imafuku, Tomohiro Omura, Kazumoto Iijima, Ikuko Yano
Research Date
Research Department
Research Journal
Clinical and Translational Science
Research Member
Research Year
2023
Research_Pages
618-630
Research Abstract