[HTML][HTML] Maternal-fetal pharmacology of drugs: a review of current status of the application of physiologically based pharmacokinetic models

N Chaphekar, P Dodeja, IH Shaik, S Caritis… - Frontiers in …, 2021 - frontiersin.org
Pregnancy and the postpartum period are associated with several physiological changes
that can alter the pharmacokinetics (PK) and pharmacodynamics (PD) of drugs. For certain …

Physiologically based pharmacokinetic modelling of drugs in pregnancy: a mini‐review on availability and limitations

M Berezowska, P Sharma… - Fundamental & …, 2024 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) modelling in pregnancy is a relatively new
approach that is increasingly being used to assess drug systemic exposure in pregnant …

A review of pregnancy-induced changes in opioid pharmacokinetics, placental transfer, and fetal exposure: towards fetomaternal physiologically-based …

MW van Hoogdalem, SL Wexelblatt, HT Akinbi… - Pharmacology & …, 2022 - Elsevier
Physiologically-based pharmacokinetic (PBPK) modeling has emerged as a useful tool to
study pharmacokinetics (PK) in special populations, such as pregnant women, fetuses, and …

Physiologically‐Based Pharmacokinetic Modeling of Anti‐Tumor Necrosis Factor Agents for Inflammatory Bowel Disease Patients to Predict the Withdrawal Time in …

J Chen, R Lin, G Guo, W Wu, M Ke, C Ke… - Clinical …, 2023 - Wiley Online Library
Anti‐tumor necrosis factor (anti‐TNF) agents are widely applied for patients with
inflammatory bowel disease (IBD); however, the timing of the last dosing for IBD pregnancy …

Minimal physiologically‐based hybrid model of pharmacokinetics in pregnant women: Application to antenatal corticosteroids

W Krzyzanski, MA Milad, AH Jobe… - CPT: Pharmacometrics …, 2023 - Wiley Online Library
Minimal physiologically‐based pharmacokinetic (mPBPK) models are an alternative to full
physiologically‐based pharmacokinetic (PBPK) models as they offer reduced complexity …

The analysis of pethidine pharmacokinetics in newborn saliva, plasma, and brain extracellular fluid after prenatal intrauterine exposure from pregnant mothers …

MM Alsmadi, N Idkaidek - European Journal of Drug Metabolism and …, 2023 - Springer
Abstract Background and Objective Pethidine (meperidine) can decrease labor pain-
associated mother's hyperventilation and high cortisol-induced newborn complications …

Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric …

G Pawar, F Wu, L Zhao, L Fang, GJ Burckart, K Feng… - The AAPS Journal, 2023 - Springer
This study investigated the impact of gastro-intestinal fluid volume and bile salt (BS)
concentration on the dissolution of carbamazepine (CBZ) immediate release (IR) 100 mg …

What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies

TG Jacobs, S Schouwenburg, M Penazzato… - The Lancet …, 2022 - thelancet.com
Although 23 antiretroviral drugs are approved for use in adults, only six are approved by
regulatory authorities for use in term neonates born to women with HIV, with even fewer …

Innovations, Opportunities, and Challenges for Predicting Alteration in Drug-Metabolizing Enzyme and Transporter Activity in Specific Populations

PP Chothe, V Arya, B Prasad, D Ramsden… - Drug Metabolism and …, 2023 - ASPET
Drug-metabolizing enzymes and transporters (DMETs) are key regulators of the
pharmacokinetics, efficacy, and toxicity of therapeutics. Over the past two decades …

[HTML][HTML] Regulatory considerations for the mother, fetus and neonate in fetal pharmacology modeling

DJ Green, K Park, V Bhatt-Mehta, D Snyder… - Frontiers in …, 2021 - frontiersin.org
The regulatory framework for considering the fetal effects of new drugs is limited. This is
partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the …