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Items: 1 to 20 of 133

1.

Haematological anticancer drugs in Europe: any added value at the time of approval?

Bertele' V, Banzi R, Capasso F, Tafuri G, Trotta F, Apolone G, Garattini S.

Eur J Clin Pharmacol. 2007 Jul;63(7):713-9. Epub 2007 May 25.

PMID:
17530236
3.

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. Epub 2002 Sep 25.

PMID:
12451425
4.

Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology.

Pignatti F, Aronsson B, Vamvakas S, Wade G, Papadouli I, Papaluca M, Moulon I, Le Courtois P.

Crit Rev Oncol Hematol. 2002 May;42(2):123-35. Review.

PMID:
12007970
5.

Therapeutic indications in oncology: emerging features and regulatory dynamics.

Tafuri G, Leufkens HG, Laing R, Trotta F.

Eur J Cancer. 2010 Feb;46(3):471-5. doi: 10.1016/j.ejca.2009.11.021. Epub 2009 Dec 26.

PMID:
20056536
6.

Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years.

Ceci A, Felisi M, Baiardi P, Bonifazi F, Catapano M, Giaquinto C, Nicolosi A, Sturkenboom M, Neubert A, Wong I.

Eur J Clin Pharmacol. 2006 Nov;62(11):947-52. Epub 2006 Oct 5.

PMID:
17021892
7.

Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization.

van Luijn JC, Gribnau FW, Leufkens HG.

Br J Clin Pharmacol. 2007 Feb;63(2):159-62. Epub 2006 Dec 7.

8.

How to anticipate the assessment of the public health benefit of new medicines?

Massol J, Puech A, Boissel JP; Participants inRound Table No 7, Giens XXII.

Therapie. 2007 Sep-Oct;62(5):427-35. doi: 10.2515/therapie:2007071. Epub 2008 Jan 19.

PMID:
18206104
9.

Efficacy and safety of immunosuppressive drugs approved in EU through the centralised procedure.

Bertele' V, Buonocore C, Michelacci F, Vitocolonna M, Garattini S.

Eur J Clin Pharmacol. 2007 Jul;63(7):707-12. Epub 2007 May 8.

PMID:
17486329
10.
11.

Accelerated approval of oncology products: a decade of experience.

Dagher R, Johnson J, Williams G, Keegan P, Pazdur R.

J Natl Cancer Inst. 2004 Oct 20;96(20):1500-9. Review.

PMID:
15494600
12.

Limits of add-on trials: antirheumatic drugs.

Ottolenghi L, Bertele' V, Garattini S.

Eur J Clin Pharmacol. 2009 Jan;65(1):33-41. doi: 10.1007/s00228-008-0545-z. Epub 2008 Sep 3. Review.

PMID:
18762934
13.

Current status of development of anticancer agents in Japan.

Morita T, Hori A, Narimatsu H, Tanimoto T, Kami M.

Int J Hematol. 2008 Jun;87(5):484-9. doi: 10.1007/s12185-008-0087-2. Epub 2008 Apr 29. Erratum in: Int J Hematol. 2008 Jun;87(5):490. Narimatatsu, Hiroto [corrected to Narimatsu, Hiroto].

PMID:
18443741
14.
15.

The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome.

Pignatti F, Aronsson B, Gate N, Vamvakas S, Wade G, Moulon I, Le Courtois P.

Eur J Clin Pharmacol. 2002 Dec;58(9):573-80. Epub 2002 Nov 13.

PMID:
12525957
16.

Choice of comparator in active control trials of new drugs.

van Luijn JC, van Loenen AC, Gribnau FW, Leufkens HG.

Ann Pharmacother. 2008 Nov;42(11):1605-12. doi: 10.1345/aph.1L115. Epub 2008 Oct 28.

PMID:
18957629
17.

Lost in translation: differences in antimicrobial indication approval policies between the United States and Europe.

Pappas G, Ierodiakonou V, Falagas ME.

Clin Ther. 2009 Jul;31(7):1595-603. doi: 10.1016/j.clinthera.2009.06.016.

PMID:
19695409
18.

Efficacy, safety and cost of new cardiovascular drugs: a survey.

Garattini S, Bertele' V.

Eur J Clin Pharmacol. 2003 Nov;59(8-9):701-6. Epub 2003 Sep 5.

PMID:
12961050
20.

[Regulation about generics approval].

Laguna-Goya N, Blázquez-Pérez A, Pozo-Hernández C.

Farm Hosp. 2006 Nov-Dec;30(6):379-84. Review. Spanish.

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