Literature DB >> 20215555

Performing phase I clinical trials of anticancer agents: perspectives from within the European union and Japan.

Martin D Forster1, Nagahiro Saijo, Lesley Seymour, Hilary Calvert.   

Abstract

Drug discovery and early clinical development is an international endeavor, conducted in partnership between commercial entities such as biotechnology and pharmaceutical companies and academic investigators. Although once considered quite disparate, early clinical trials requirements and conduct are largely harmonized between the European Union, Japan, and the United States, increasing the opportunities for productive commercial-academic collaborations.

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Year:  2010        PMID: 20215555     DOI: 10.1158/1078-0432.CCR-09-2228

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN: 1078-0432            Impact factor:   12.531


  4 in total

1.  Differences in maximum tolerated doses and approval doses of molecularly targeted oncology drug between Japan and Western countries.

Authors:  Hideki Maeda; Tatsuo Kurokawa
Journal:  Invest New Drugs       Date:  2014-03-11       Impact factor: 3.850

2.  Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials.

Authors:  David M Hyman; Anne A Eaton; Mrinal M Gounder; Gary L Smith; Erika G Pamer; Martee L Hensley; David R Spriggs; Percy Ivy; Alexia Iasonos
Journal:  J Clin Oncol       Date:  2014-01-13       Impact factor: 44.544

3.  The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.

Authors:  Lesley Seymour; S Percy Ivy; Daniel Sargent; David Spriggs; Laurence Baker; Larry Rubinstein; Mark J Ratain; Michael Le Blanc; David Stewart; John Crowley; Susan Groshen; Jeffrey S Humphrey; Pamela West; Donald Berry
Journal:  Clin Cancer Res       Date:  2010-03-09       Impact factor: 12.531

4.  NCI-RTOG translational program strategic guidelines for the early-stage development of radiosensitizers.

Authors:  Yaacov Richard Lawrence; Bhadrasain Vikram; James J Dignam; Arnab Chakravarti; Mitchell Machtay; Boris Freidlin; Naoko Takebe; Walter J Curran; Soren M Bentzen; Paul Okunieff; C Norman Coleman; Adam P Dicker
Journal:  J Natl Cancer Inst       Date:  2012-12-10       Impact factor: 13.506

  4 in total

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