Toxicologic Pathology

 

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Toxicologic Pathology, Vol. 30, No. 1, 8-10 (2002)
DOI: 10.1080/01926230252824653

Practical Aspects of Discovery Pathology

John E. Burkhardt

Department of Drug Safety Evaluation, Pfizer Global Research and Development, Groton, CT, USA, John_E_Burkhardt{at}groton.pfizer.com.

Anne M. Ryan

Department of Drug Safety Evaluation, Pfizer Global Research and Development, Groton, CT, USA

Paul-Georg Germann

Preclinical Safety, Novartis Pharma AG, Basel, Switzerland

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.

Key Words: Animal models • confidence in mechanism • confidence in safety • toxicology • rats • mouse phenotyping • monoclonal antibodies • VEGF • AMD.


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