Optimizing Oncology Therapeutics Through Quantitative Translational and Clinical Pharmacology: Challenges and Opportunities

Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure–respon...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2015-01, Vol.97 (1), p.37-54
Main Authors: Venkatakrishnan, K, Friberg, LE, Ouellet, D, Mettetal, JT, Stein, A, Trocóniz, IF, Bruno, R, Mehrotra, N, Gobburu, J, Mould, DR
Format: Article
Language:English
Subjects:
Animals
Antineoplastic Agents - adverse effects
Antineoplastic Agents - pharmacology
Antineoplastic Agents - therapeutic use
Biomedical Research - methods
Computer Simulation
Drug Design
Drug Evaluation, Preclinical - methods
Humans
Models, Theoretical
Molecular Targeted Therapy
Neoplasms - drug therapy
Neoplasms - pathology
Pharmacology, Clinical - methods
Translational Medical Research - methods
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Summary:Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure–response understanding to optimize the benefit–risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical‐translational phase through confirmatory clinical evaluation of efficacy and safety.
ISSN:0009-9236
1532-6535
1532-6535
DOI:10.1002/cpt.7