Subject
Pharmaceutical Science,General Medicine,Biotechnology
Reference60 articles.
1. European Medicines Agency, ICH guideline E8 (R1) on general considerations for clinical studies. EMA/CHMP/ICH/544570/1998, 2021.
2. European Medicines Agency, Reflection paper on the use of extrapolation in the development of medicines for paediatrics - Final. EMA/189724/2018, 2018.
3. Extrapolation of adult data and other data in pediatric drug-development programs;Dunne;Pediatrics,2011
4. Extrapolation of efficacy and other data to support the development of new medicines for children: A systematic review of methods;Wadsworth;Stat. Methods Med. Res.,2018
5. Commentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatrics;Ollivier;Br. J. Clin. Pharmacol.,2019