196 related articles for article (PubMed ID: 24903307)
1. Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee--adolescents' melanoma as a paradigm.
Rose K; Senn S
Pharm Stat; 2014; 13(4):211-3. PubMed ID: 24903307
[TBL] [Abstract][Full Text] [Related]
2. Do the European Medicines Agency Decisions Hurt Pediatric Melanoma Patients?
Rose K; Walson PD
Clin Ther; 2017 Feb; 39(2):253-265. PubMed ID: 28159363
[TBL] [Abstract][Full Text] [Related]
3. European Union pediatric legislation jeopardizes worldwide, timely future advances in the care of children with cancer.
Rose K
Clin Ther; 2014 Feb; 36(2):163-77. PubMed ID: 24529288
[TBL] [Abstract][Full Text] [Related]
4. Do Paediatric Investigation Plans (PIPs) Advance Paediatric Healthcare?
Rose K; Walson PD
Paediatr Drugs; 2017 Dec; 19(6):515-522. PubMed ID: 28889403
[TBL] [Abstract][Full Text] [Related]
5. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.
Wimmer S; Rascher W; McCarthy S; Neubert A
Paediatr Drugs; 2014 Oct; 16(5):397-406. PubMed ID: 25056717
[TBL] [Abstract][Full Text] [Related]
6. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.
Hwang TJ; Tomasi PA; Bourgeois FT
PLoS Med; 2018 Mar; 15(3):e1002520. PubMed ID: 29494592
[TBL] [Abstract][Full Text] [Related]
7. The European Regulation on medicines for paediatric use.
Dunne J
Paediatr Respir Rev; 2007 Jun; 8(2):177-83. PubMed ID: 17574163
[TBL] [Abstract][Full Text] [Related]
8. Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.
Tomasi PA; Egger GF; Pallidis C; Saint-Raymond A
Paediatr Drugs; 2017 Dec; 19(6):505-513. PubMed ID: 28900869
[TBL] [Abstract][Full Text] [Related]
9. Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseases.
Stefanska AM; Distlerová D; Musaus J; Olski TM; Dunder K; Salmonson T; Mentzer D; Müller-Berghaus J; Hemmings R; Veselý R
Arch Dis Child; 2017 Oct; 102(10):952-957. PubMed ID: 28554892
[TBL] [Abstract][Full Text] [Related]
10. Juvenile animal studies and pediatric drug development: a European regulatory perspective.
Carleer J; Karres J
Birth Defects Res B Dev Reprod Toxicol; 2011 Aug; 92(4):254-60. PubMed ID: 21638754
[TBL] [Abstract][Full Text] [Related]
11. More than 5 years of European Paediatric Regulation: statistics and industrial experience.
Winzenburg G
Int J Pharm; 2014 Aug; 469(2):260-2. PubMed ID: 24704106
[TBL] [Abstract][Full Text] [Related]
12. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
13. Creating a unique, multi-stakeholder Paediatric Oncology Platform to improve drug development for children and adolescents with cancer.
Vassal G; Rousseau R; Blanc P; Moreno L; Bode G; Schwoch S; Schrappe M; Skolnik J; Bergman L; Bradley-Garelik MB; Saha V; Pearson A; Zwierzina H
Eur J Cancer; 2015 Jan; 51(2):218-24. PubMed ID: 25434924
[TBL] [Abstract][Full Text] [Related]
14. Pediatric investigation plans for specific immunotherapy: Questionable contributions to childhood health.
Rose K; Kopp MV
Pediatr Allergy Immunol; 2015 Dec; 26(8):695-701. PubMed ID: 26495999
[TBL] [Abstract][Full Text] [Related]
15. Three years of paediatric regulation in the European Union.
Olski TM; Lampus SF; Gherarducci G; Saint Raymond A
Eur J Clin Pharmacol; 2011 Mar; 67(3):245-52. PubMed ID: 21286912
[TBL] [Abstract][Full Text] [Related]
16. Drug evaluation in children 10years after the European pediatric regulation current challenges and perspectives.
Élie V; Leroux S; Kaguelidou F; Jacqz-Aigrain E
Therapie; 2018 Apr; 73(2):113-117. PubMed ID: 29580612
[TBL] [Abstract][Full Text] [Related]
17. The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia.
Rose K; Walson PD
Risk Manag Healthc Policy; 2015; 8():185-205. PubMed ID: 26604845
[TBL] [Abstract][Full Text] [Related]
18. Paediatric investigation plans for pain: painfully slow!
Davies EH; Ollivier CM; Saint Raymond A
Eur J Clin Pharmacol; 2010 Nov; 66(11):1091-7. PubMed ID: 20821198
[TBL] [Abstract][Full Text] [Related]
19. Who are the PDCO?
Dempsey EM; Connolly K
Eur J Pediatr; 2014 Feb; 173(2):233-5. PubMed ID: 23925423
[TBL] [Abstract][Full Text] [Related]
20. Progress review of the European Paediatric Regulatory Framework after six years of implementation.
Mentzer D
Int J Pharm; 2014 Aug; 469(2):240-3. PubMed ID: 24613178
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
