Bio-waiver is a term used for product approvals, particularly tablet/capsule, without requiring an in vivo (bio-equivalence/bio-availability) testing commonly required to establish the safety, efficacy, and quality of drug products. For bio-waivers, the requirement of bio-equivalence/bio-availability studies is substituted with in vitro drug release testing, commonly known as drug dissolution testing. It is, therefore, extremely important to note that drug dissolution testing is used as a surrogate of in vivo (bio-equivalence/bio-availability) testing. Stating otherwise is clearly not an accurate view or representation of the science.
In addition, regulatory, including pharmacopeial, requirements of in vitro drug dissolution testing are based on the assumption that if products met the dissolution test criteria, then products would be considered safe, efficacious, and of quality for human use. This is the reason that dissolution tests are often promoted as quality control/assurance tests for pharmaceutical products (e.g., tablets/capsules).
However, unfortunately, the dissolution tests (methods/testers) often recommended and used have never been qualified and/or validated for their intended purpose. The assessment of the quality of such products, using the recommended testers/methods, lacks scientific support and merit. Therefore, current practices of requiring bio-waivers lack scientific merit or credibility; thus, their requirements should be reconsidered.