When should comparative clinical trial studies be conducted to demonstrate bioequivalence?
The Committee discussed the use of dissolution testing to establish bioequivalence for drugs that act in the GI tract. The members added that in vitro testing is good if there is control over the test. The members emphasized that dissolution tests are needed early on in the process, in order to narrow down the variables. Further, pharmacokinetics studies are useful to assure safety of the test product. In addition, the members stressed that dissolution tests are formulation tests, and can be a surrogate for clinical tests. The Committee discussed that dissolution tests can be very discriminating if the study is designed well. Although the committee felt that the Agency had all the data necessary to do dissolution testing for the products being discussed, dissolution test procedures can be simple for some drugs, but complicated for others. The Committee argued that when a lot of background information is available, the dissolution test could be used. However, the members added that when
