BIOS 7433

Biopharmaceutical Statistics in Drug Development: 3-0-3

Statistical aspects of drug research and development, federal regulations, and marketing will be studied. Specifically, statistical methods useful in the areas of pharmaceutical discovery and optimization, assessment of pharmacological activity, pharmaceutical formulation, preclinical and clinical safety assessment, clinical development, bio-availability and bio-equivalence, clinical traits with quantitative and qualitative measurements, cancer clinical trials, and manufacturing and quality control processes will be studied. Prerequisites: BIOS 6331 and BIOS 6332 or equivalent.