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Physiologically based pharmacokinetic (PBPK) modeling and simulation in neonatal drug development: how clinicians can contribute

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Pages 25-34 | Received 27 Jul 2018, Accepted 07 Dec 2018, Published online: 17 Dec 2018

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Karen Leys, Marina-Stefania Stroe, Pieter Annaert, Steven Van Cruchten, Sebastien Carpentier, Karel Allegaert & Anne Smits. (2023) Pharmacokinetics during therapeutic hypothermia in neonates: from pathophysiology to translational knowledge and physiologically-based pharmacokinetic (PBPK) modeling. Expert Opinion on Drug Metabolism & Toxicology 19:7, pages 461-477.
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Evelina Cardoso, Monia Guidi, Nina Nauwelaerts, Hedvig Nordeng, Marie Teil, Karel Allegaert, Anne Smits, Peggy Gandia, Andrea Edginton, Shinya Ito, Pieter Annaert & Alice Panchaud. (2023) Safety of medicines during breastfeeding – from case report to modeling: a contribution from the ConcePTION project. Expert Opinion on Drug Metabolism & Toxicology 19:5, pages 269-283.
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Karel Allegaert, Mohammad Yaseen Abbasi, Pieter Annaert & Olusola Olafuyi. (2022) Current and future physiologically based pharmacokinetic (PBPK) modeling approaches to optimize pharmacotherapy in preterm neonates. Expert Opinion on Drug Metabolism & Toxicology 18:5, pages 301-312.
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Karel Allegaert, Robert Flint & Anne Smits. (2019) Pharmacokinetic modelling and Bayesian estimation-assisted decision tools to optimize vancomycin dosage in neonates: only one piece of the puzzle. Expert Opinion on Drug Metabolism & Toxicology 15:9, pages 735-749.
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Articles from other publishers (20)

Martje Van Neste, Annick Bogaerts, Nina Nauwelaerts, Julia Macente, Anne Smits, Pieter Annaert & Karel Allegaert. (2023) Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants—A Contribution from the ConcePTION Project. Pharmaceutics 15:11, pages 2618.
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Nada M. El Hoffy, Ahmed S. Yacoub, Amira M. Ghoneim, Magdy Ibrahim, Hussein O. Ammar & Nermin Eissa. (2023) Computational Amendment of Parenteral In Situ Forming Particulates’ Characteristics: Design of Experiment and PBPK Physiological Modeling. Pharmaceutics 15:10, pages 2513.
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Mo'tasem M. Alsmadi & Saja B. Alzughoul. (2022) In vitro–in vivo extrapolation of bexarotene metabolism in the presence of chronic kidney disease and acute kidney injury in rat using physiologically based pharmacokinetic modeling and extrapolation to human . Biopharmaceutics & Drug Disposition 44:3, pages 221-244.
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Deepika Deepika & Vikas Kumar. (2023) The Role of “Physiologically Based Pharmacokinetic Model (PBPK)” New Approach Methodology (NAM) in Pharmaceuticals and Environmental Chemical Risk Assessment. International Journal of Environmental Research and Public Health 20:4, pages 3473.
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Anne Smits, Pieter Annaert, Giacomo Cavallaro, Pieter A. J. G. De Cock, Saskia N. de Wildt, Jenny M. Kindblom, Florian B. Lagler, Carmen Moreno, Paula Pokorna, Michiel F. Schreuder, Joseph F. Standing, Mark A. Turner, Benedetto Vitiello, Wei Zhao, Annelie‐Martina Weingberg, Raffaella Willmann, John van den Anker & Karel Allegaert. (2021) Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper. British Journal of Clinical Pharmacology 88:12, pages 4965-4984.
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Architha Aithal, Shubhrajyotsna Aithal & P. S. Aithal. (2022) Case Study on Certara’s Simcyp PBPK Simulator to Eliminate Lengthy Clinical Trails. International Journal of Health Sciences and Pharmacy, pages 69-109.
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Wen Lin, Yuan Chen, Jashvant D. Unadkat, Xinyuan Zhang, Di Wu & Tycho Heimbach. (2022) Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective. Pharmaceutical Research 39:8, pages 1701-1731.
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Karel Allegaert & John N. van den Anker. (2022) From immature pharmacotherapy towards pharmacotherapy of the immature. Seminars in Fetal and Neonatal Medicine 27:2, pages 101327.
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Jeffrey W. Fisher, Darshan Mehta, Miao Li & Xiaoxia Yang. 2022. Clinical Pharmacology During Pregnancy. Clinical Pharmacology During Pregnancy 437 456 .
Kaixiang Zhou, Kun Mi, Wenjin Ma, Xiangyue Xu, Meixia Huo, Samah Attia Algharib, Yuanhu Pan, Shuyu Xie & Lingli Huang. (2021) Application of physiologically based pharmacokinetic models to promote the development of veterinary drugs with high efficacy and safety. Journal of Veterinary Pharmacology and Therapeutics 44:5, pages 663-678.
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Xiaomei I. Liu, John N. den Anker, Gilbert J. Burckart & André Dallmann. (2021) Evaluation of Physiologically Based Pharmacokinetic Models to Predict the Absorption of BCS Class I Drugs in Different Pediatric Age Groups. The Journal of Clinical Pharmacology 61:S1.
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Huiping Huang, Helin Xie, Nupur Chaphekar, Ruichao Xu, Raman Venkataramanan & Xuemei Wu. (2021) A Physiologically Based Pharmacokinetic Analysis To Predict the Pharmacokinetics of Intravenous Isavuconazole in Patients with or without Hepatic Impairment. Antimicrobial Agents and Chemotherapy 65:5.
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John N. Van den Anker, Susan McCune, Pieter Annaert, Gerri R. Baer, Yeruk Mulugeta, Ramy Abdelrahman, Kunyi Wu, Kevin M. Krudys, Jeffrey Fisher, William Slikker, Connie Chen, Gilbert J. Burckart & Karel Allegaert. (2020) Approaches to Dose Finding in Neonates, Illustrating the Variability between Neonatal Drug Development Programs. Pharmaceutics 12:7, pages 685.
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Lisa Cheng & Harvey Wong. (2020) Food Effects on Oral Drug Absorption: Application of Physiologically-Based Pharmacokinetic Modeling as a Predictive Tool. Pharmaceutics 12:7, pages 672.
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Anne Smits, Pieter Annaert, Steven Van Cruchten & Karel Allegaert. (2020) A Physiology-Based Pharmacokinetic Framework to Support Drug Development and Dose Precision During Therapeutic Hypothermia in Neonates. Frontiers in Pharmacology 11.
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Fazila Bunglawala, Rajith K R Rajoli, Mark Mirochnick, Andrew Owen & Marco Siccardi. (2020) Prediction of dolutegravir pharmacokinetics and dose optimization in neonates via physiologically based pharmacokinetic (PBPK) modelling. Journal of Antimicrobial Chemotherapy 75:3, pages 640-647.
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Jose-Manuel delMoral-Sanchez, Isabel Gonzalez-Alvarez, Marta Gonzalez-Alvarez, Andres Navarro & Marival Bermejo. (2019) Classification of WHO Essential Oral Medicines for Children Applying a Provisional Pediatric Biopharmaceutics Classification System. Pharmaceutics 11:11, pages 567.
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Genny Raffaeli, Pavla Pokorna, Karel Allegaert, Fabio Mosca, Giacomo Cavallaro, Enno D. Wildschut & Dick Tibboel. (2019) Drug Disposition and Pharmacotherapy in Neonatal ECMO: From Fragmented Data to Integrated Knowledge. Frontiers in Pediatrics 7.
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Fiona O’Brien, David Clapham, Kamelia Krysiak, Hannah Batchelor, Peter Field, Grazia Caivano, Marisa Pertile, Anthony Nunn & Catherine Tuleu. (2019) Making Medicines Baby Size: The Challenges in Bridging the Formulation Gap in Neonatal Medicine. International Journal of Molecular Sciences 20:11, pages 2688.
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Karel Allegaert, Anne Smits & John N. van den Anker. (2019) Phenobarbital Increases Midazolam Clearance in Neonates Treated with Hypothermia: Do We Really Need to Know?. Neonatology 116:2, pages 188-190.
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