15.136J | Fall 2013 | Graduate

Principles and Practice of Drug Development

Course Description

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and …
This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.
Learning Resource Types
Lecture Notes
Projects
Presentation Assignments
Two dose-response curves showing different amounts of a drug on the x-axis, and effect on the body on the y-axis. The resulting curves for "desired effect" and "side effect" both have a steep slope with a slight "S" shape before leveling off at the top.
An example of a dose-response curve which shows how much of a drug causes a particular effect or side effect in the body (Crabtree + Company, National Institute of General Medical Sciences).