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Historical perspective

Pauline De Bruyne (UGent) , Shinya Ito and Facundo Garcia-Bournissen
(2024) Essentials of translational pediatric drug development : from past needs to future oportunities. p.21-32
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Abstract
Before any new medicine can be marketed, it must receive a marketing authorization (MA, or license) after fulfilling the requirements of the relevant regulatory agencies (e.g, European Medicines Agency [EMA] and Food and Drug Administration [FDA]) put in place to ensure the safety and efficacy of said medicine. These licensing processes were introduced as a response to pediatric drug tragedies that occurred between the late 1930s and early 1960s. During the last three decades, the United States (US) and the European Union (EU) have introduced strong paediatric initiatives to improve the paediatric situation, mostly through legislative measures aimed at increasing the number and quality of studies in children. These legislative changes have been introduced in response to scientific studies, documenting the extent of off-label and unlicensed drug use in paediatric patients. This section will not only focus on initiatives that stimulate the number of clinical trials but also on the initiatives to harmonize the conduct of clinical trials worldwide.
Keywords
Marketing authorization, Food and drug administration, Pediatric, Pediatric regulation, Pharmacokinetics, Pharmacodynamics

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MLA
De Bruyne, Pauline, et al. “Historical Perspective.” Essentials of Translational Pediatric Drug Development : From Past Needs to Future Oportunities, edited by Elke Gasthuys et al., Academic press, 2024, pp. 21–32, doi:10.1016/b978-0-323-88459-4.00002-x.
APA
De Bruyne, P., Ito, S., & Garcia-Bournissen, F. (2024). Historical perspective. In E. Gasthuys, K. Allegaert, L. Dossche, & M. Turner (Eds.), Essentials of translational pediatric drug development : from past needs to future oportunities (pp. 21–32). https://doi.org/10.1016/b978-0-323-88459-4.00002-x
Chicago author-date
De Bruyne, Pauline, Shinya Ito, and Facundo Garcia-Bournissen. 2024. “Historical Perspective.” In Essentials of Translational Pediatric Drug Development : From Past Needs to Future Oportunities, edited by Elke Gasthuys, Karel Allegaert, Lien Dossche, and Mark Turner, 21–32. Academic press. https://doi.org/10.1016/b978-0-323-88459-4.00002-x.
Chicago author-date (all authors)
De Bruyne, Pauline, Shinya Ito, and Facundo Garcia-Bournissen. 2024. “Historical Perspective.” In Essentials of Translational Pediatric Drug Development : From Past Needs to Future Oportunities, ed by. Elke Gasthuys, Karel Allegaert, Lien Dossche, and Mark Turner, 21–32. Academic press. doi:10.1016/b978-0-323-88459-4.00002-x.
Vancouver
1.
De Bruyne P, Ito S, Garcia-Bournissen F. Historical perspective. In: Gasthuys E, Allegaert K, Dossche L, Turner M, editors. Essentials of translational pediatric drug development : from past needs to future oportunities. Academic press; 2024. p. 21–32.
IEEE
[1]
P. De Bruyne, S. Ito, and F. Garcia-Bournissen, “Historical perspective,” in Essentials of translational pediatric drug development : from past needs to future oportunities, E. Gasthuys, K. Allegaert, L. Dossche, and M. Turner, Eds. Academic press, 2024, pp. 21–32.
@incollection{01J6YNM4B0F5T5AMA9HHRQ9F4K,
  abstract     = {{Before any new medicine can be marketed, it must receive a marketing authorization (MA, or license) after fulfilling the requirements of the relevant regulatory agencies (e.g, European Medicines Agency [EMA] and Food and Drug Administration [FDA]) put in place to ensure the safety and efficacy of said medicine. These licensing processes were introduced as a response to pediatric drug tragedies that occurred between the late 1930s and early 1960s. During the last three decades, the United States (US) and the European Union (EU) have introduced strong paediatric initiatives to improve the paediatric situation, mostly through legislative measures aimed at increasing the number and quality of studies in children. These legislative changes have been introduced in response to scientific studies, documenting the extent of off-label and unlicensed drug use in paediatric patients. This section will not only focus on initiatives that stimulate the number of clinical trials but also on the initiatives to harmonize the conduct of clinical trials worldwide.}},
  author       = {{De Bruyne, Pauline and Ito, Shinya and Garcia-Bournissen, Facundo}},
  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     = {{Marketing authorization,Food and drug administration,Pediatric,Pediatric regulation,Pharmacokinetics,Pharmacodynamics}},
  language     = {{eng}},
  pages        = {{21--32}},
  publisher    = {{Academic press}},
  title        = {{Historical perspective}},
  url          = {{http://doi.org/10.1016/b978-0-323-88459-4.00002-x}},
  year         = {{2024}},
}
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