General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children-Reference-Cited by-同舟云学术

General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

Published:2022-11-08 Issue:12 Volume:88 Page:4985-4996
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

Bouazza Naïm¹²³,Dokoumetzidis Aristides⁴^ORCID,Knibbe Catherijne A. J.⁵⁶^ORCID,de Wildt Saskia N.⁷⁸^ORCID,Ambery Claire⁹,De Cock Pieter A.¹⁰¹¹¹²,Gasthuys Elke¹³,Foissac Frantz¹²³^ORCID,Urien Saïk¹²³,Hamberg Anna‐Karin¹⁴,Poggesi Italo¹⁵,Zhao Wei¹⁶¹⁷¹⁸^ORCID,Vermeulen An¹³,Standing Joseph F.¹⁹²⁰^ORCID,Tréluyer Jean‐Marc¹²³^ORCID,

Affiliation:

1. Pediatric and Perinatal Drug Evaluation and Pharmacology Université Paris Cité Paris France

2. Unité de Recherche Clinique Université Paris Cité Necker‐Cochin, AP‐HP Paris France

3. CIC‐1419 Inserm, Cochin‐Necker Paris France

4. Department of Pharmacy National and Kapodistrian University of Athens Athens Greece

5. Division of Systems Biomedicine and Pharmacology, Leiden Academic Centre for Drug Research Leiden University Leiden The Netherlands

6. Department of Clinical Pharmacy St. Antonius Hospital Nieuwegein The Netherlands

7. Department of Pharmacology and Toxicology, Radboud Institute for Health Sciences Radboud University Medical Center Nijmegen The Netherlands

8. Department of Intensive Care and Paediatric Surgery Erasmus MC‐Sophia Children's Hospital Rotterdam The Netherlands

9. Clinical Pharmacology Modelling and Simulation GlaxoSmithKline plc London UK

10. Department of Basic and Applied Medical Sciences Ghent University Ghent Belgium

11. Department of Pharmacy Ghent University Hospital Ghent Belgium

12. Department of Pediatric Intensive Care Ghent University Hospital Ghent Belgium

13. Department of Bioanalysis, Faculty of Pharmaceutical Sciences University of Ghent Ghent Belgium

14. Department of Clinical Pharmacology Uppsala University Hospital Uppsala Sweden

15. Clinical Pharmacology and Pharmacometrics Janssen Research & Development Beerse Belgium

16. Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine Shandong University Jinan China

17. Department of Pharmacy The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital Jinan China

18. Clinical Research Centre The First Affiliated Hospital of Shandong First Medical University and Shandong Provincial Qianfoshan Hospital Jinan China

19. Infection, Inflammation and Immunology UCL Great Ormond Street Institute of Child Health London UK

20. Department of Pharmacy Great Ormond Street Hospital for Children London UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15571

Reference68 articles.

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2. Anonymous.Extrapolation of efficacy and safety in paediatric medicine development [Internet]. European Medicines Agency.2018[cité 16 juill 2021]. Disponible sur:https://www.ema.europa.eu/en/extrapolation-efficacy-safety-paediatric-medicine-development

3. Pharmacometrics|Wiley Online Books [Internet]. [cité 2 juin2022]. Disponible sur: doi:10.1002/0470087978

4. Understanding and applying pharmacometric modelling and simulation in clinical practice and research

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