It is a well-established understanding that the drug/pharmaceutical industry is a highly regulated industry. The purpose of the elaborate regulations and their implementation is that the products manufactured should be of the highest quality standards possible.  There are numerous sources of such regulations, most often country- or territory-specific such as US, Japan, European etc., or some others harmonized such as from ICH. However, in general the most commonly referred, or quoted, are those from the US FDA, US Pharmacopeia, EMA and ICH.

Regulatory authorities such as US FDA, Health Canada, EMA and many others enforce such regulations and standards to ascertain that manufacturers and manufactured products are in-compliance with regulations leading to manufacturing of quality products. It is very important to note that a fundamental underlying assumption here is that if a product or process is in-compliance then the product or process will be of quality. In general such an underlying assumption is correct; however, for the pharmaceutical industry this underlying assumption does not appear to be valid. Continue reading →

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.