Drug Approval Process

This following note has nothing to do with schizophrenia directly - but there are always some people who try to dismiss the contribution of drug companies to helping those with schizophrenia. As you can see, the process of coming out with a new medication is not a trivial one - and while no medication is yet a cure for schizophrenia the newest medications can (when used in conjunction with a comprehensive psychiatric program) frequently help many people. As always, skepticsm is in order when evaluating the claims of any company's products, and talk with the experts in this field before making any changes in medication, or when evaluating new medications. Brian.

The average timeline to develop a new drug through the complex system of clinical trials, applications, and approvals is 8 to 12 years. The average cost is $359 million. Only one in every 10,000 molecules that are considered for development ultimately wins approval. In this class, Dr. Worku Negash, a pharmaceutical and biotechnical consultant, outlines each step in the rigorous and painstaking drug development process. A former Syntex executive, Negash explains how a high-level team of medical, research, manufacturing, marketing, regulatory and managerial experts is assigned to shepherd each prospective new drug through the system.

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