It is important to note that by definition a drug dissolution test has to be a biorelevant test. A non-biorelevant dissolution test is just like a non-biorelevant thermometer or non-biorelevant pair of eye glasses i.e. such things have no practical use or purpose. However, unfortunately, in the pharmaceutical area, in particular for oral (tablet/capsule) products, not only does such non-biorelevant testing exist (e.g. pharmacopeial) but it is the norm, strongly promoted and defended which causes enormous confusion and financial losses.
The reason for this confusion is that non-biorelevant methods are presented as biorelevant and useful in fancy wrappings, or with catchy phrases, e.g. the one mentioned in the title (“biorelevant performance testing”) or by confusing with other names such as BCS, IVIVC, bio-waivers, f2, QbD etc. In reality, the issue is not how is dissolution testing presented and described, but rather how the tests are conducted and results are evaluated.
For example: (1) the apparatuses currently used, even those recommended by regulatory authorities, have never been qualified and/or validated for dissolution testing purposes. In fact, it has been shown many times that the apparatuses provide irrelevant and unreliable results; (2) recommended experimental conditions are mostly selected arbitrarily lacking physiological or scientific rationale; (3) tests are conducted using product specific (i.e. not product independent) procedures or experimental conditions thus results obtained are biased and cannot relate to the actual quality of a product; (4) there are no existing criteria or standards available which could be used to relate dissolution results for product quality. That is, no procedure is available to set physiologically relevant tolerances with scientific or statistical relevancy or credibility. For further details see here.
In conclusion, if dissolution results have been obtained using traditional approaches/methods then their interpretation and usefulness will be of questionable merit at best.
