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

Bouazza, Naim (författare)
Univ Paris Cite, Pediat & Perinatal Drug Evaluat & Pharmacol, F-75006 Paris, France.;Univ Paris Cite, Necker Cochin, AP HP, Unite Rech Clin, Paris, France.;Cochin Necker, CIC 1419 Inserm, Paris, France.
Dokoumetzidis, Aristides (författare)
Natl & Kapodistrian Univ Athens, Dept Pharm, Athens, Greece.
Knibbe, Catherijne A. J. (författare)
Leiden Univ, Leiden Acad Ctr Drug Res, Div Syst Biomed & Pharmacol, Leiden, Netherlands.;St Antonius Hosp, Dept Clin Pharm, Nieuwegein, Netherlands.
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de Wildt, Saskia N. (författare)
Radboud Univ Nijmegen, Radboud Inst Hlth Sci, Dept Pharmacol & Toxicol, Med Ctr, Nijmegen, Netherlands.;Erasmus MC Sophia Childrens Hosp, Dept Intens Care & Paediat Surg, Rotterdam, Netherlands.
Ambery, Claire (författare)
GlaxoSmithKline Plc, Clin Pharmacol Modelling & Simulat, London, England.
De Cock, Pieter A. (författare)
Univ Ghent, Dept Basic & Appl Med Sci, Ghent, Belgium.;Ghent Univ Hosp, Dept Pharm, Ghent, Belgium.;Ghent Univ Hosp, Dept Pediat Intens Care, Ghent, Belgium.
Gasthuys, Elke (författare)
Univ Ghent, Fac Pharmaceut Sci, Dept Bioanal, Ghent, Belgium.
Foissac, Frantz (författare)
Univ Paris Cite, Pediat & Perinatal Drug Evaluat & Pharmacol, F-75006 Paris, France.;Univ Paris Cite, Necker Cochin, AP HP, Unite Rech Clin, Paris, France.;Cochin Necker, CIC 1419 Inserm, Paris, France.
Urien, Saik (författare)
Univ Paris Cite, Pediat & Perinatal Drug Evaluat & Pharmacol, F-75006 Paris, France.;Univ Paris Cite, Necker Cochin, AP HP, Unite Rech Clin, Paris, France.;Cochin Necker, CIC 1419 Inserm, Paris, France.
Hamberg, Anna-Karin, 1964- (författare)
Uppsala universitet,Klinisk farmakogenomik och osteoporos
Poggesi, Italo (författare)
Janssen Res & Dev, Clin Pharmacol & Pharmacometr, Beerse, Belgium.
Zhao, Wei (författare)
Shandong Univ, Cheeloo Coll Med, Sch Pharmaceut Sci, Dept Clin Pharm,Key Lab Chem Biol,Minist Educ, Jinan, Peoples R China.;Shandong First Med Univ, Dept Pharm, Affiliated Hosp 1, Jinan, Peoples R China.;Shandong Prov Qianfoshan Hosp, Jinan, Peoples R China.;Shandong First Med Univ, Clin Res Ctr, Affiliated Hosp 1, Jinan, Peoples R China.
Vermeulen, An (författare)
Univ Ghent, Fac Pharmaceut Sci, Dept Bioanal, Ghent, Belgium.
Standing, Joseph F. (författare)
UCL Great Ormond St Inst Child Hlth, Infect Inflammat & Immunol, London, England.;Great Ormond St Hosp Sick Children, Dept Pharm, London, England.
Treluyer, Jean-Marc (författare)
Univ Paris Cite, Pediat & Perinatal Drug Evaluat & Pharmacol, F-75006 Paris, France.;Univ Paris Cite, Necker Cochin, AP HP, Unite Rech Clin, Paris, France.;Cochin Necker, CIC 1419 Inserm, Paris, France.
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Univ Paris Cite, Pediat & Perinatal Drug Evaluat & Pharmacol, F-75006 Paris, France;Univ Paris Cite, Necker Cochin, AP HP, Unite Rech Clin, Paris, France.;Cochin Necker, CIC 1419 Inserm, Paris, France. Natl & Kapodistrian Univ Athens, Dept Pharm, Athens, Greece. (creator_code:org_t)
2022-11-08
2022
Engelska.
Ingår i: British Journal of Clinical Pharmacology. - : John Wiley & Sons. - 0306-5251 .- 1365-2125. ; 88:12, s. 4985-4996
Relaterad länk:
https://urn.kb.se/re...
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https://doi.org/10.1...
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  • Forskningsöversikt (refereegranskat)
Abstract Ämnesord
Stäng  
  • Pharmacometric modelling plays a key role in both the design and analysis of regulatory trials in paediatric drug development. Studies in adults provide a rich source of data to inform the paediatric investigation plans, including knowledge on drug pharmacokinetics (PK), safety and efficacy. In children, drug disposition differs widely from birth to adolescence but extrapolating adult to paediatric PK, safety and efficacy either with pharmacometric or physiologically based approaches can help design or in some cases reduce the need for clinical studies. Aspects to consider when extrapolating PK include the maturation of drug metabolizing enzyme expression, glomerular filtration, drug excretory systems, and the expression and activity of specific transporters in conjunction with other drug properties such as fraction unbound. Knowledge of these can be used to develop extrapolation tools such as allometric scaling plus maturation functions or physiologically based PK. PK/pharmacodynamic approaches and well-designed clinical trials in children are of key importance in paediatric drug development. In this white paper, state-of-the-art of current methods used for paediatric extrapolation will be discussed. This paper is part of a conect4children implementation of innovative methodologies including pharmacometric and physiologically based PK modelling in clinical trial design/paediatric drug development through dissemination of expertise and expert advice. The suggestions arising from this white paper should define a minimum set of standards in paediatric modelling and contribute to the regulatory science.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)

Nyckelord

allometry
modelling
paediatric
physiologically based pharmacokinetics
pharmacometrics
simulation

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