Drug Development: The Short Story
4. An Overview of the Process
There are several stages to drug development, each of which requires a significant investment of time, money, and resources. The overall process is shown below.
The research department is responsible for promoting new chemical entities to the point that they can be administered to humans. Chemists synthesize thousands of new molecules whose structures are confirmed by analytical chemists and are screened for activity by pharmacologists. Compounds shown to be active in preliminary tests (primary screens) are tested against defined profiles to select promising clinical candidates.
Once the activity of the new chemical lead is confirmed, several parallel activities are initiated. Process research begins to develop new synthesis routes which will permit the preparation of large quantities of the compound. At the same time, the safety evaluation group starts a short term examination to determine the toxicity of the new compound. As laboratory results from these activities unfold, research scientists and clinicians begin developing plans for human trials, product packaging, and benefits for future studies. If all of these activities are successful, each of the studies, reports, and procedures are combined and formatted into the Investigational New Drug Application. While the research department may work to develop additional compounds within the same class (analogues) to serve as a backup to the primary clinical candidate, approval of the IND formally ends the research department's connection with the compound.
As the figure above shows, the clinical trials phase of development is a series of parallel and inter-related activities. Problems in any of these areas will halt development. Before discussing the research and development processes in detail, a brief description of the time lines and costs associated with drug development will follow.
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