1. Pediatric drug development: challenges and opportunities;Spadoni C.;Curr. Ther. Res. Clin. Exp.,2018
2. The revolution in pediatric drug development and drug use: therapeutic orphans no more;Burckart G.J.;J. Pediatr. Pharmacol. Ther.,2020
3. Timing of pediatric drug approval and clinical evidence submitted to regulatory authorities: International comparison among Japan, the United States, and the European Union;Hirota S.;Clin. Pharmacol. Ther.,2020
4. US Food and Drug Administration.Guidance for industry: general clinical pharmacology considerations for pediatric studies for drugs and biological products (2014).
5. European Medicines Authority. Reflection paper on the use of extrapolation in the development of medicines for paediatrics (2017).