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Journal of Clinical Pharmacology|September 15, 2022
The Use of Pregnancy Physiologically Based Pharmacokinetic Modeling for Renally Cleared DrugsPaola Coppola, Essam Kerwash, Susan Cole
Pharmaceutics|July 27, 2024
Casgevy: Innovative Medicinal Products Require Innovative Approaches to Regulatory AssessmentEssam Kerwash, John D Johnston
Drug Metabolism and Pharmacokinetics|January 31, 2020
A summary of the current drug interaction guidance from the European Medicines Agency and considerations of future updatesSusan Cole, Essam Kerwash, Anita Andersson
Frontiers in Pediatrics|July 12, 2021
Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model EvaluationPaola Coppola, Essam Kerwash, Susan Cole
Journal of Clinical Pharmacology|June 15, 2023
Use of Physiologically Based Pharmacokinetic Modeling for Hepatically Cleared Drugs in Pregnancy: Regulatory PerspectivePaola Coppola, Essam Kerwash, Susan Cole
Life (Basel, Switzerland)|June 26, 2025
Altuvoct: Innovative Medicinal Products Benefit from Innovative Approaches to Regulatory AssessmentEssam Kerwash, Maria Malamatari, John D Johnston
Clinical and Translational Science|June 13, 2026
Quantitative Medicine to Support Drug Development and Regulatory Decisions: A UK Regulatory Approach Informed by ICH M15Essam Kerwash, Andrew S Butler, Maria Malamatari, et al.
Pharmaceutics|October 28, 2023
Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on EfficacyPaola Coppola, Andrew Butler, Susan Cole, et al.
Frontiers in Medicine|October 21, 2022
Pharmacokinetic data in pregnancy: A review of available literature data and important considerations in collecting clinical dataPaola Coppola, Essam Kerwash, Janet Nooney, et al.
CPT: Pharmacometrics & Systems Pharmacology|November 19, 2024
Investigation of a fully mechanistic physiologically based pharmacokinetics model of absorption to support predictions of milk concentrations in breastfeeding women and the exposure of infants: A case study for albendazoleSusan Cole, Maria Malamatari, Andrew Butler, et al.
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