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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1.2. Statistical support to non-clinical activities
In an eloquent viewpoint article, Dennis Lendrem (2002) discussed non-clinical statistical support. Traditionally, statistical thinking and approaches are more embraced in areas where regulators have issued guidelines. Examples are pre-clinical testing of cardiac liability, carcinogenicity, and stability testing. Recently, Good Manufacturing Practice has also become a subject of great regulatory interest. The latter captured public attention when manufacturing problems created a shortage of the flu vaccines for the 2004–2005 season. By comparison, statistical input in areas such as high-throughput screening, chemical development, formulation development, drug delivery, and assay development ...
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