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- Title
Development of Rational Drug Combinations with Investigational Targeted Agents.
- Authors
Clark, Adam; Ellis, Matthew; Erlichman, Charles; Lutzker, Stuart; Zwiebel, James
- Abstract
The article focuses on an alternative regulatory process to the combination rule in drug development. It states several benefits of the alternative model such as the potential for combination therapies to synergistically target tumors. It mentions the 2new molecular entity (NME) strategy which has the potential to improve the number and quality of cancer clinical trials. Furthermore, it says that the current regulatory approval process should be modified with the new therapies in development.
- Subjects
REGULATORY approval; REGULATORY reform; DRUG development; THERAPEUTICS; TUMOR treatment; CLINICAL trials
- Publication
Oncologist, 2010, Vol 15, Issue 5, p496
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2009-0262