Pharmacometrics in pregnancy: an unmet need

AB Ke, A Rostami-Hodjegan, P Zhao… - Annual review of …, 2014 - annualreviews.org
Pregnant women and their fetuses are orphan populations with respect to the safety and
efficacy of drugs. Physiological and absorption, distribution, metabolism, and excretion (ADME) …

Drug dosing in pregnant women: challenges and opportunities in using physiologically based pharmacokinetic modeling and simulations

AB Ke, R Greupink, K Abduljalil - CPT: pharmacometrics & …, 2018 - Wiley Online Library
The unmet medical need of providing evidence‐based pharmacotherapy for pregnant
women is recognized by the regulatory bodies. Physiologically based pharmacokinetic (PBPK) …

Expansion of a PBPK model to predict disposition in pregnant women of drugs cleared via multiple CYP enzymes, including CYP2B6, CYP2C9 and CYP2C19

AB Ke, SC Nallani, P Zhao… - British journal of …, 2014 - Wiley Online Library
Aim Conducting PK studies in pregnant women is challenging. Therefore, we asked if a
physiologically‐based pharmacokinetic ( PBPK ) model could be used to predict the disposition …

A physiologically based pharmacokinetic model to predict disposition of CYP2D6 and CYP1A2 metabolized drugs in pregnant women

AB Ke, SC Nallani, P Zhao, A Rostami-Hodjegan… - Drug Metabolism and …, 2013 - ASPET
Conducting pharmacokinetic (PK) studies in pregnant women is challenging. Therefore, we
asked if a physiologically based pharmacokinetic (PBPK) model could be used to evaluate …

Impact of disease on plasma and lung exposure of chloroquine, hydroxychloroquine and azithromycin: application of PBPK modeling

…, M Zhang, X Pan, A Ban Ke… - Clinical …, 2020 - Wiley Online Library
We use a mechanistic lung model to demonstrate that accumulation of chloroquine (CQ),
hydroxychloroquine (HCQ), and azithromycin (AZ) in the lungs is sensitive to changes in lung …

Prediction of CYP‐mediated DDIs involving inhibition: approaches to address the requirements for system qualification of the Simcyp simulator

…, K Crewe, I Gardner, O Hatley, AB Ke… - CPT …, 2022 - Wiley Online Library
Physiologically‐based pharmacokinetic (PBPK) modeling is being increasingly used in drug
development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform …

Evaluation of maternal drug exposure following the administration of antenatal corticosteroids during late pregnancy using physiologically‐based pharmacokinetic …

AB Ke, MA Milad - Clinical Pharmacology & Therapeutics, 2019 - Wiley Online Library
Betamethasone and dexamethasone are the most widely studied antenatal corticosteroids (
ACS ) administered to pregnant women, just prior to the birth of a preterm neonate, to …

Modeling cyclosporine A inhibition of the distribution of a P-glycoprotein PET ligand, 11C-verapamil, into the maternal brain and fetal liver of the pregnant nonhuman …

AB Ke, S Eyal, FS Chung, JM Link… - Journal of Nuclear …, 2013 - Soc Nuclear Med
Through PET imaging, our laboratory has studied the dynamic biodistribution of 11 C-verapamil,
a P-gp substrate, in the nonhuman primate Macaca nemestrina. To gain detailed insight …

A physiologically based pharmacokinetic-pharmacodynamic modelling approach to predict incidence of neutropenia as a result of drug-drug interactions of paclitaxel …

…, O Hatley, KL Gill, KR Yeo, AB Ke - European Journal of …, 2020 - Elsevier
Paclitaxel is the backbone of standard chemotherapeutic regimens used in a number of
malignancies and is frequently given with concomitant medications. Newly developed oncolytic …

Estimation of brain receptor occupancy for trazodone immediate release and once a day formulations

…, MT Rosignoli, S McFeely, AB Ke… - Clinical and …, 2022 - Wiley Online Library
Trazodone is approved for the treatment of major depressive disorders, marketed as
immediate release (IR), prolonged release, and once a day (OAD) formulation. The different …