The PVT (Performance Verification Test) for all practical purposes is a name change of an old test known as dissolution apparatus calibration. This test has been propagated to provide some sort of assurance about the performance of the drug dissolution apparatuses commonly known as Paddle and Basket. However, the test has been faced with criticism about its relevance and usefulness almost from the beginning. In fact, it is generally considered a severe economical burden on pharmaceutical manufacturers. To minimize this burden and a lack of scientific rationale, FDA recently provides an alternate to avoid the PVT.
On the other hand, USP, which propagates the use of PVT, and the provider of the tablets used for PVT, has been making tremendous efforts in convincing that the PVT is indeed a useful practice. However, selling this idea appears to be becoming difficult because, generally, analysts/scientists consider this as “an effort to maintain the status quo”. This status quo impression appears to have merit because there has been no experimental evidence provided to address the users’ concerns or establish the usefulness and relevance of the PVT.
At this stage, the question remains that if PVT fails (which it often does without any apparent reasons), what experimental evidence are available to reflect that the apparatus was not functioning as expected? Otherwise, why propagate the use of PVT?
On the other hand, lack of evidence regarding the usefulness of PVT gives strength to the reported observations that problems with PVT are reflections of problems of Paddle and Basket apparatuses (poor hydrodynamics, variable and unpredictable results) themselves.