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Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle
- Source :
- Clinical Cancer Research. 22:2613-2617
- Publication Year :
- 2016
- Publisher :
- American Association for Cancer Research (AACR), 2016.
-
Abstract
- In the current era of rapid marketing approval for promising new products in oncology, dose finding and optimization for small-molecule oncology drugs occurs throughout the development cycle and into the postmarketing setting. Many trials that support a regulatory application have high rates of dose reductions and discontinuations, which may result in postmarketing requirements (PMR) to study alternate doses or dosing schedules. Kinase inhibitors particularly have been susceptible to this problem, and among the 31 approved drugs of this class, the approvals of eight have included such PMRs and/or commitments. Thus, the current paradigm for dose finding and optimization could be improved. Newer strategies for dose finding rather than traditional 3 + 3 designs should be considered where feasible, and dose optimization should be continued after phase I and throughout development. Such strategies will increase the likelihood of a right dose for the right drug at the time of regulatory approval. Clin Cancer Res; 22(11); 2613–7. ©2016 AACR. See all articles in this CCR Focus section, “New Approaches for Optimizing Dosing of Anticancer Agents.”
- Subjects :
- Drug
Cancer Research
medicine.medical_specialty
media_common.quotation_subject
Antineoplastic Agents
Pharmacology
Regulatory Application
030226 pharmacology & pharmacy
Software development process
03 medical and health sciences
Dose finding
0302 clinical medicine
Dosing schedules
Neoplasms
Humans
Medicine
Molecular Targeted Therapy
Dosing
Intensive care medicine
Drug Approval
Protein Kinase Inhibitors
media_common
High rate
Clinical Trials as Topic
Dose-Response Relationship, Drug
business.industry
Oncology
030220 oncology & carcinogenesis
business
Oncology drugs
Subjects
Details
- ISSN :
- 15573265 and 10780432
- Volume :
- 22
- Database :
- OpenAIRE
- Journal :
- Clinical Cancer Research
- Accession number :
- edsair.doi.dedup.....b2fa118a14a6dac18bde5d2848c21935