Observational infant exploratory [14C]-paracetamol pharmacokinetic microdose/therapeutic dose study with accelerator mass spectrometry bioanalysis

Author:

Garner Colin R.12,Park Kevin B.3,French Neil S.3,Earnshaw Caroline3,Schipani Alessandro3,Selby Andrew M.4,Byrne Lindsay4,Siner Sarah4,Crawley Francis P.5,Vaes Wouter H. J.6,van Duijn Esther6,deLigt Rianne6,Varendi Heili7,Lass Jane7,Grynkiewicz Grzegorz8,Maruszak Wioletta8,Turner Mark A.9

Affiliation:

1. Hull York Medical School; University of York; Heslington York YO1 5DD United Kingdom

2. United Kingdom and Garner Consulting; 5 Hall Drive, Sand Hutton York YO41 1LA United Kingdom

3. Institute of Translational Medicine; University of Liverpool; Crown Street Liverpool L69 3BX United Kingdom

4. Alder Hey Children's NHS Foundation Trust; Eaton Road, West Derby Liverpool L12 2AP United Kingdom

5. Good Clinical Practice Alliance - Europe; Schoolbergenstraat 47 BE-3010 Kessel-Lo Belgium

6. TNO Zeist; Utrechtseweg 48, PO Box 360 3700 AJ Zeist The Netherlands

7. Department of Paediatrics; Tartu University Hospital, University of Tartu; 51014 Tartu Estonia

8. Pharmaceutical Research Institute; 8 Rydygiera Street 01-793 Warsaw Poland

9. Department of Women's and Children's Health, Institute of Translational Medicine; University of Liverpool, University of Liverpool; Liverpool L69 3BX United Kingdom

Funder

Medical Research Council

Estonian Science Foundation

Narodowym Centrum Bada I Rozwojugrant

ZonMW

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference44 articles.

1. Antibiotic dosing in children in Europe: can we grade the evidence from pharmacokinetic/pharmacodynamic studies-and when is enough data enough?;Barker;Curr Opin Infect Dis,2012

2. FDA, U.S. Guidance for industry, pediatric study plans:content of and process for submitting initial pediatric study plans and amended pediatric study plans 2013 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM360507.pdf

3. Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations;Bartelink;Clin Pharmacokinet,2006

4. Understanding the relative roles of pharmacogenetics and ontogeny in pediatric drug development and regulatory science;Leeder;J Clin Pharmacol,2010

5. Developmental expression of drug metabolizing enzymes: impact on disposition in neonates and young children;Hines;Int J Pharm,2013

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