Practical aspects of discovery pathology

被引:4
作者
Burkhardt, JE
Ryan, AM
German, PG
机构
[1] Pfizer Inc, Global Res & Dev, Dept Drug Safety Evaluat, Groton, CT 06340 USA
[2] Novartis Pharma AG, Preclin Safety, Basel, Switzerland
关键词
animal models; confidence in mechanism; confidence in safety; toxicology; rats; mouse phenotyping; monoclonal antibodies; VEGF; AMD;
D O I
10.1080/01926230252824653
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
Pathologists are uniquely qualified to play a central role in driving drug discovery and development programs by: 1) establishing disease models to assess potential therapies, 2) characterizing modifications in the disease state in response to therapies, 3) characterizing toxicologic mechanisms and responses to drug candidates, and 4) facilitating multidisciplinary efforts to monitor for the clinical occurrence, progression, and reversibility of adverse events. Such nontraditional deployment of resources must, to be viable, produce benefits to the pharmaceutical industry comparable to those of more conventional activities such as delivery of data in nonclinical safety studies. Additionally, benefits must be tangible from standpoints such as timesavings or improved quality of research decisions, manifesting as either program acceleration or improved candidate survival.
引用
收藏
页码:8 / 10
页数:3
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