Abstract: Therapeutic equivalence test is used to show whether a new drug is effective as a standard drug in the shortage of bioequivalence.The paper discussed some important issues with some examples, such as the choice of equivalence margin, primary endpoint of trials, the design of trials, and statistical analysis in the therapeutic equivalence.The current status of the research was evaluated as well.These are important to the employment and development of therapeutic equivalence.

Key words: biometry, therapeutic equivalence, equivalence margin, target parameter, design of trials, statistical analysis, evaluation