341 related articles for article (PubMed ID: 21286912)
1. 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]
2. 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]
3. 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]
4. Oral medicines for children in the European paediatric investigation plans.
van Riet-Nales DA; Römkens EG; Saint-Raymond A; Kozarewicz P; Schobben AF; Egberts TC; Rademaker CM
PLoS One; 2014; 9(6):e98348. PubMed ID: 24897509
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. 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]
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. 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]
9. Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations.
Ecker A; Mariz S; Naumann-Winter F; Norga K; Barisic I; Girard T; Tomasi P; Mentzer D; Sepodes B
Arch Dis Child; 2018 May; 103(5):427-430. PubMed ID: 29089318
[TBL] [Abstract][Full Text] [Related]
10. 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]
11. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013.
Egger GF; Wharton GT; Malli S; Temeck J; Murphy MD; Tomasi P
Ther Innov Regul Sci; 2016 Sep; 50(5):639-647. PubMed ID: 27274951
[TBL] [Abstract][Full Text] [Related]
12. Cardiovascular Paediatric Medicines Development: Have Paediatric Investigation Plans Lost Heart?
Faulkner B; Delgado-Charro MB
Pharmaceutics; 2020 Dec; 12(12):. PubMed ID: 33276598
[TBL] [Abstract][Full Text] [Related]
13. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. 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]
16. 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]
17. Fighting trafficking of falsified and substandard medicinal products in Russia.
Fayzrakhmanov NF
Int J Risk Saf Med; 2015; 27 Suppl 1():S37-40. PubMed ID: 26639702
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. [Pediatric drug development: ICH harmonized tripartite guideline E11 within the United States of America, the European Union, and Japan].
Pflieger M; Bertram D
Arch Pediatr; 2014 Oct; 21(10):1129-38. PubMed ID: 25175054
[TBL] [Abstract][Full Text] [Related]
20. 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]
[Next] [New Search]
