Tomasi PA - Search Results

1

Availability of paediatric information in European Medicines Agency approvals.

Hwang TJ, Tomasi PA, Saint-Raymond A, Bourgeois FT. Hwang TJ, et al. Among authors: tomasi pa. Lancet Child Adolesc Health. 2018 May;2(5):e9. doi: 10.1016/S2352-4642(18)30101-9. Epub 2018 Apr 12. Lancet Child Adolesc Health. 2018. PMID: 30169272 No abstract available.

2

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. Hwang TJ, et al. Among authors: tomasi pa. PLoS Med. 2018 Mar 1;15(3):e1002520. doi: 10.1371/journal.pmed.1002520. eCollection 2018 Mar. PLoS Med. 2018. PMID: 29494592 Free PMC article.

3

Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.

Tomasi PA, Egger GF, Pallidis C, Saint-Raymond A. Tomasi PA, et al. Paediatr Drugs. 2017 Dec;19(6):505-513. doi: 10.1007/s40272-017-0261-1. Paediatr Drugs. 2017. PMID: 28900869 Review.

4

Important issues in the justification of a control treatment in paediatric drug trials.

Kelly LE, Davies EH, Saint-Raymond A, Tomasi P, Offringa M. Kelly LE, et al. Arch Dis Child. 2016 Oct;101(10):962-7. doi: 10.1136/archdischild-2016-310644. Epub 2016 Apr 6. Arch Dis Child. 2016. PMID: 27052950 Review.

5

Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors.

Silva-Lima B, Due Theilade-Thomsen M, Carleer J, Vidal JM, Tomasi P, Saint-Raymond A. Silva-Lima B, et al. Birth Defects Res B Dev Reprod Toxicol. 2010 Dec;89(6):467-73. doi: 10.1002/bdrb.20257. Birth Defects Res B Dev Reprod Toxicol. 2010. PMID: 20632393

6

The development of pharmacological treatment of obesity in children. A European regulatory perspective.

Karres J, Tomasi P, Saint Raymond A. Karres J, et al. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 May;54(5):570-6. doi: 10.1007/s00103-011-1271-8. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011. PMID: 21547648

7

Role of modeling and simulation in pediatric investigation plans.

Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A. Manolis E, et al. Paediatr Anaesth. 2011 Mar;21(3):214-21. doi: 10.1111/j.1460-9592.2011.03523.x. Epub 2011 Jan 18. Paediatr Anaesth. 2011. PMID: 21244569 Review.

8

More medicines for children: impact of the EU paediatric regulation.

Nordenmalm S, Tomasi P, Pallidis C. Nordenmalm S, et al. Arch Dis Child. 2018 Jun;103(6):557-564. doi: 10.1136/archdischild-2017-313309. Epub 2018 Feb 28. Arch Dis Child. 2018. PMID: 29490933

9

The importance and challenge of pediatric trials of hemophilia drugs.

Mentzer D, Desfontaine E, Tomasi PA. Mentzer D, et al. Among authors: tomasi pa. Nat Med. 2014 May;20(5):465. doi: 10.1038/nm.3546. Nat Med. 2014. PMID: 24804748 No abstract available.

10

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. Ecker A, et al. Arch Dis Child. 2018 May;103(5):427-430. doi: 10.1136/archdischild-2017-313352. Epub 2017 Oct 31. Arch Dis Child. 2018. PMID: 29089318

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