Drug Development differs essentially by the type of a project (innovative, me-too, generic) and the type of the performing company (large pharmaceutical, generic, small cap/start-up). Sometimes it is seen as a combination or sequence of steps in the area of chemical and pharmaceutical production and quality (CMC, compiled in Module 3), non-clinical development (focussing on pharmacodynamic and pharmacokinetic characterization and safety issues compiled in Module 4) and clinical characterization (including clinical safety and efficacy in the intended use and population compiled in Module 5). |