374 related articles for article (PubMed ID: 28900869)
1. 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]
2. 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]
3. 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]
4. 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]
5. 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]
6. 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]
7. 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]
8. 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]
9. 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]
10. More medicines for children: impact of the EU paediatric regulation.
Nordenmalm S; Tomasi P; Pallidis C
Arch Dis Child; 2018 Jun; 103(6):557-564. PubMed ID: 29490933
[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. Will children with cancer benefit from the new European Paediatric Medicines Regulation?
Vassal G
Eur J Cancer; 2009 Jun; 45(9):1535-46. PubMed ID: 19419857
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. 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]
15. 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]
16. Moving toward a paradigm shift in the regulatory requirements for pediatric medicines.
Chin WW; Joos A
Eur J Pediatr; 2016 Dec; 175(12):1881-1891. PubMed ID: 27646479
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.
Jackson EL; Feldschreiber P; Breckenridge A
Clin Pharmacol Ther; 2017 Aug; 102(2):183-184. PubMed ID: 28555841
[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. 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]
[Next] [New Search]