This course provides an overview of how new pharmaceutical products are identified and developed. The roles and interactions among marketing, clinical R&D, regulatory affairs, and manufacturing will be reviewed. A basic description of the Investigational New Drug Application (IND) will lead to a review of how clinical trials are started, completed, and reported; ethical considerations in conducting clinical research; filing a New Drug Application (NDA) and interactions with the FDA.
The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines.
The course material focuses on developing drugs and biologics under FDA regulations and ICH guidelines.
