Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

Pharmacokinetics (PK) is the study of the absorption, distribution, metabolism, and excretion
(ADME) processes of a drug. Understanding PK properties is essential for drug development …

Developmental changes in children can affect the disposition and clinical effects of a drug,
indicating that scaling an adult dose simply down per linear weight can potentially lead to …

Prescription drug use is prevalent during pregnancy, yet there is limited knowledge about
maternal-fetal safety and efficacy of this drug use because pregnant individuals have …

Drugs can have harmful effects on the embryo or the fetus at any point during pregnancy.
Not all the damaging effects of intrauterine exposure to drugs are obvious at birth, some may …

Medication (drug) use in human pregnancy is prevalent. Determining fetal safety and
efficacy of drugs is logistically challenging. However, predicting (not measuring) fetal drug …

Tremendous efforts have been directed to investigate the ontogeny of drug transporters in
fetuses, neonates, infants, and children based on their importance for understanding drug …

Concerns over maternal and fetal drug exposures highlight the need for a better
understanding of drug distribution into the fetus through the placental barrier. This study …

Cell-based test methods with a phenotypic readout are frequently used for toxicity screening.
However, guidance on how to validate the hits and how to integrate this information with …

Perinatal pharmacology is influenced by a myriad of physiological variables that are
changing dynamically. The influence of these covariates has not been assessed …