Challenges in the Pharmaceutical Industry/Development Process
How are medications developed?
The development of a medicines or medical devices is a highly complicated and costly process. The most important steps will be briefly outlined here /1/.
In the first step the potential active ingredients will be synthesized. Modern high-throughput facilities manufacture up to 300,000 substances per day. A fraction of those substances show positive effects, and are then identified as “hit-substances.” These substances are starting points for the development of better substances, and are not ready to be used for the treatment of patients. The molecule will be chemically modified until a compatible active ingredient is found.
In the pre-clinical development the active ingredient will be extensively reviewed and chemically and physically characterized. Furthermore, the substance will be reviewed toxicologically and tested to see if the drug has adverse affects such as causing damage to embryos, triggering cancer, or inducing changes in genetic make-up.