Pharmaceutical Statistics Using SAS

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 ...