Therapeutic Equivalence: A Connecting Link Between Test Drug and Reference Drug

Abstract

The concept of therapeutic equivalence is becoming increasingly important in today’s cost – conscious environment. Though an effective therapy already exists, but clinically equivalent therapy also becoming important. An improved toxicity profile better effects on symptoms and ease of administration may be important considerations. In these positive controls substantial effect is required to define equivalence. The goal is to prove that the new treatment is not inferior to standard, since providing that two treatments are equal is not possible. The superiority trials demonstrate the better efficacy of the treatment against the concurrent placebo control.  Innovative drugs become available for the treatment of number of diseases. These, new products may offer some specific advantages over the standard drugs. The Placebo controlled trials are invariably unethical, when known effective therapy is available for the condition being studies. The active controlled trials are used extensively in the development of new pharmaceuticals. The equivalence limit is defined by a lower equivalence or upper equivalence limit. These, principles are proposed for setting such limits, depending on the objective of the study placebo conditions and methods based on statistical properties.