Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases-Reference-Cited by-同舟云学术

Drug approval based on randomized phase 3 trials for relapsed malignancy: analysis of oncologic drugs granted accelerated approval, publications and clinical trial databases

Published:2018-02-17 Issue:3 Volume:36 Page:487-495
ISSN:0167-6997
Container-title:Investigational New Drugs
language:en
Short-container-title:Invest New Drugs

Author:

Nagai Sumimasa^ORCID,Ozawa Keiya

Funder

Japan Society for the Promotion of Science

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Oncology

Link

http://link.springer.com/article/10.1007/s10637-018-0572-2/fulltext.html

Reference39 articles.

1. Johnson JR, Ning YM, Farrell A, Justice R, Keegan P, Pazdur R (2011) Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 103:636–644

2. Gaddipati H, Liu K, Pariser A, Pazdur R (2012) Rare cancer trial design: lessons from FDA approvals. Clin Cancer Res 18:5172–5178

3. Johnson JR, Williams G, Pazdur R (2003) End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21:1404–1411

4. Sridhara R, Johnson JR, Justice R, Keegan P, Chakravarty A, Pazdur R (2010) Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst 102:230–243

5. Simon R, Blumenthal GM, Rothenberg ML et al (2015) The role of nonrandomized trials in the evaluation of oncology drugs. Clin Pharmacol Ther 97:502–507

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