Biological oncology drugs

Preclinical Safety Evaluation of Biological Oncology Drugs... 

PRECLINICAL SAFETY EVALUATION OF BIOLOGICAL ONCOLOGY DRUGS... 

Pilaro A. Nonclinical perspective on initiating phase 1 studies for biological oncology products—Case studies. Oncology Drugs Advisory Committee, March 13, 2006. 

Table 10.1 provides some examples of cardiotoxicity information listed in drug labels of oncologic drugs and biologies. These examples include QT prolongation/tor flrfe, hypertension, and cardiomyopathy, each of which is then discussed in more detail. 

Phillips T. Biochemical Modifiers Drug-Radiation Interactions. In Mauch PM, Loeffler JS, eds. Radiation Oncology Technology and Biology. Philadelphia WB Saunders Company 1994. pp. 113-152. 

Toshiyuki Kohno Laboratory of Structural Biology, Mitsubishi Kagaku Institute of Life Sciences (MITILS), Tokyo, Japan Kit S. Lam Division of Hematology Oncology, Department of Internal Medicine, UC Davis Cancer Center, University of California, Davis, CA Rob Lf.i irs Division of Medicinal Chemistry, Leiden/Amsterdam Center for Drug Research (LACDR), Faculty of Sciences, Vrije Universiteit, Amsterdam, The Netherlands... 

A number of animal model systems have been developed to provide tumor microenvironments that mimic the clinical situation. However, there are no perfect animal models for drug development. The adequacy of any specific animal model depends on its validity, selectivity, predictability, and reproducibility (22). In cancer chemotherapy, animal models are selected to simultaneously demonstrate antitumor efficacy and evaluate systemic toxicities in an intact organism. Ideally, the tumor system under study in the animal model should be genetically stable over time, with homogeneous characteristics that mimic human tumor biology. In oncology, a variety of diverse animal models for human tumors have been developed. These models can be broadly categorized in to three... 

U.S. Department of Health and Human Services, Food Drug Administration, Center for Drug Evaluation and Research and Center for Biologies Evaluation and Research. Guidance for industry Pediatric Oncology Studies in Response to a Written Request. Rockville, MD 2000. 

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