February 2007
Beginner to intermediate
464 pages
16h
English
book
Pharmaceutical Statistics Using SAS
by Ph. D. Alex Dmitrienko, Ph. D. Christy Chuang-Stein, Sr. Ralph B. D'Agostino
Content preview from Pharmaceutical Statistics Using SAS
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5.1. Overview of Nonclinical Safety Assessment
The goal of drug development is to identify safe and efficacious treatments for human diseases. Safety and efficacy are assessed through careful evaluation in animal models and in vitro systems (nonclinical setting) and in exposed human populations (clinical setting) throughout drug development and post-marketing. This chapter focuses on the design and analysis of studies that are integral to nonclinical safety assessment.
The objectives in nonclinical safety assessment are to define the toxicity profile of candidate drugs, estimate the margin of safety by understanding the relationship between toxic exposures and efficacious exposures, and provide a judgment on the likelihood that the animal findings ...
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