Current requirements of bio-waivers lack scientific merit!

Bio-waiver is a term used for product approvals, in particular tablet/capsule, without requiring an in vivo (bio-equivalence/bio-availability) testing commonly required to establish safety, efficacy and quality of drug products. For bio-waivers, 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 an assumption that if products would meet the dissolution test criteria, then products would be considered as 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 quality of such products, using the recommended testers/methods, lack scientific support and merit. Therefore, current practices of requiring bio-waivers lack scientific merit or credibility thus their requirements should be reconsidered.

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