Biopharmaceutic planning in pediatric drug development.

The AAPS Journal
Vivek S Purohit

Abstract

Pediatric drug development is a required consideration for all drug development programs. Age-appropriate formulations such as suspensions, chewable tablets, oral disintegrating tablets, etc., are typically developed and used in the pediatric clinical studies. However, it is not uncommon to use enabling formulations in the pivotal pediatric clinical study followed by bridging bioavailability and/or bioequivalence studies. Development of age-appropriate formulations is an essential part of pediatric drug development and adds additional biopharmaceutical considerations to an already complex problem. Careful planning of biopharmaceutic data collection during the adult and pediatric development program can contribute significantly to the biopharmaceutic risk assessment and planning of appropriate clinical studies leading to successful development of pediatric formulations.

References

Sep 19, 2003·The New England Journal of Medicine·Gregory L KearnsRalph E Kauffman
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Citations

Sep 10, 2015·AAPS PharmSciTech·Aline Santos da SilvaFabiana Ernestina Barcellos da Silva
May 15, 2013·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Hannah K BatchelorUNKNOWN European Paediatric Formulation Initiative
Nov 6, 2013·Advanced Drug Delivery Reviews·Hannah K BatchelorSandra Klein
Jun 29, 2016·International Journal of Pharmaceutics·Hannah BatchelorUNKNOWN EuPFI
Sep 21, 2016·European Journal of Pediatrics·William Wei Lim Chin, Angelika Joos
Jan 4, 2017·Journal of Pharmaceutical Sciences·David P ElderMartin Kuentz
Jul 5, 2018·The Journal of Pharmacy and Pharmacology·Mariana GuimarãesNikoletta Fotaki
Sep 1, 2014·Clinical Pharmacology in Drug Development·Thomas N KakudaRichard M W Hoetelmans
Apr 21, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Yuet Mei KhongArzu Selen
Aug 21, 2021·Drug Research·Budi PrasajaPrawitasari Cahyaningsih

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