Modeling and simulation of drug disposition has emerged as an important tool in drug
development, clinical study design and regulatory review, and the number of physiologically …

Prenatal life represents a susceptible window of development during which chemical
exposures can permanently alter fetal development, leading to an increased likelihood of …

Pharmacotherapy during pregnancy is often inevitable for medical treatment of the mother,
the fetus or both. The knowledge of drug transport across placenta is, therefore, an important …

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 …

Aims Pregnant women are usually not part of the traditional drug development programme.
Pregnancy is associated with major biological and physiological changes that alter the …

Pregnant women and their fetuses are orphan populations with respect to the safety and
efficacy of drugs. Physiological and absorption, distribution, metabolism, and excretion …

The unmet medical need of providing evidence‐based pharmacotherapy for pregnant
women is recognized by the regulatory bodies. Physiologically based pharmacokinetic …

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 …

Besides logistical and ethical concerns, evaluation of safety and efficacy of medications in
pregnant women is complicated by marked changes in pharmacokinetics (PK) of drugs. For …

Conducting pharmacokinetic (PK) studies in pregnant women is challenging. Therefore, we
asked if a physiologically based pharmacokinetic (PBPK) model could be used to evaluate …