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CLINICAL ENDPOINT STUDIES
An endpoint is the outcome that researcher’s measure during a clinical trial in order to determine whether or not an experimental therapy is effective. Researchers select endpoints based on clinical trial design, the nature of the condition being treated, and the anticipated effect of the drug being tested. In some cases of generic drugs, the bioavailability cannot be demonstrated using conventional PK/PD studies.
Hence a clinical end point is determined to demonstrate the equivalence to the innovator product. A clinical endpoint is an outcome that represents direct clinical benefit, such as survival, decreased pain, or the absence of disease.