@incollection{01J6YNB5N7WP5JYDFVKPSAWG4T,
  abstract     = {{This book provides an overview of pediatric drug development. The chapters aim to provide practical guidance to healthcare providers who are new to drug development and to drug developers who are new to pediatrics or intend to inform any stakeholder involved in pediatric drug development. This introductory chapter provides an overview of the “logic” of drug development in general and for pediatrics in particular. This chapter includes an overview of pharmacovigilance given the central role of safety assessment in drug development. By “logic,” we mean the steps that move from a starting position (a potential drug) to a final position (a quality-controlled body of data that support prescribing). By pediatrics, we mean neonates (preterm and term, until 27 days after the expected date of delivery), infants (from 28 days until 1 year after birth), children from (from 1 year until the onset of puberty), and young people/adolescents (from the onset of puberty until adulthood). Adulthood is defined legally rather than biologically. Chronologic age alone may not serve as an adequate categorical determinant to define developmental subgroups in pediatric studies. There are other ways of subdividing the pediatric population—the best subdivision depends on the drug and the condition being studied. Physiological development and maturity of organs, pathophysiology and natural history of the disease or condition, available treatment options, and the pharmacology of the investigational product should hereby be considered (EMA, 2017). Sometimes, this and other chapters use “pediatric population,” “children,” and “babies, children, and young people.” These phrases should be read as synonyms.}},
  author       = {{Turner, Mark and Gasthuys, Elke and Dossche, Lien and Allegaert, Karel}},
  booktitle    = {{Essentials of translational pediatric drug development : from past needs to future oportunities}},
  editor       = {{Gasthuys, Elke and Allegaert, Karel and Dossche, Lien and Turner, Mark}},
  isbn         = {{9780323884594}},
  keywords     = {{Clinical trials,Drug development,Linear approach,Marketing authorization,Pediatrics,Pharmacokinetics,Pharmacovigilance}},
  language     = {{eng}},
  pages        = {{3--19}},
  publisher    = {{Elsevier}},
  title        = {{Preface : overview of pediatric drug development and pharmacovigilance}},
  url          = {{http://doi.org/10.1016/b978-0-323-88459-4.00001-8}},
  year         = {{2024}},
}

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