Validation (Method/Apparatus) Practices

A common and frequent response to number of different queries, regarding choices in apparatuses, media or other experimental conditions, is that the changes and choices must be validated. The responses are as varied as number of respondents and their views. This leaves people usually even more confused than before asking the question. The reason for this confusion is that one cannot validate an apparatus or method using current practices of dissolution testing. Therefore, mostly respondents, in good faith, suggest what it may be, not what it is or should be, because no one knows what it is and what exactly is expected.

The question may only be answered, if one has a procedure, or lead to a procedure, as to how an apparatus was validated to start with. For example, how was it established that paddle/basket are indeed validated apparatuses? That is, how was this established that paddle/basket apparatuses are good for their purpose (QC, discriminatory, IVIVC etc)? If we have that procedure, then we may follow the procedure to establish validity of other secondary steps (changes, alteration, improvements etc). As we, to our knowledge, do not have that initial procedure which was used to establish the validity of paddle/basket, we cannot perform a secondary validation.

Thus, it should be kept in mind that current practices of validation in this respect are more like rituals/traditions than based on facts from experimental science.

Hope this will help and simplify your future dissolution work and validation steps.

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