Abstract
This chapter presents the practical challenges facing the oncology clinical pharmacologist by surveying the cancer chemotherapies approved by the FDA in the period between January 2009 and June 2015. For each new medicine, the contents of the review summaries published by the FDA in the Drugs@FDA database at the time of first approval are examined. The comments of reviewers in the areas of subject and patient selection, dose and regimen justification, characterization of food and pH-altering drug interactions, evaluation of dose adjustment for organ impaired populations, and QTc assessment of new oncology therapeutics are presented. The information gleaned from the 44 approvals for new oncology drugs during this period provides the reader with an insight into the expectations and requirements for initial approval and provide practical information for how regulatory guidance is applied in clinical pharmacology.
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Howard, D.R. (2016). Practical Considerations for Clinical Pharmacology in Drug Development: A Survey of 44 FDA Oncology Approvals. In: Bonate, P., Howard, D. (eds) Pharmacokinetics in Drug Development. Springer, Cham. https://doi.org/10.1007/978-3-319-39053-6_12
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