Suggestions of developing and validating dissolution methods using compendial apparatuses, which are not qualified and validated, are simply promoting false science and useless practice!

The above title is self-explanatory, clear and says it all.

People have to be careful when offered help in developing and/or validating dissolution methods based on non-validated apparatuses (e.g. paddle/basket) and/or experimental conditions. The results obtained would not be of any use, even for QC purposes, no matter how they are presented.

The following links may be of further help in this regard.

(1)    If one cannot determine dissolution characteristics of a product then how would one be able to establish its quality or bio-relevance? A serious flaw of current practices! (link).

(2)    De-aeration of a medium and vibration free environment – perfect attention deflectors (link).

(3)    Note that no one can determine, or has determined, dissolution characteristics of any product using the currently suggested apparatuses and/or methods. It has all been an illusion! (link).

(4)    Assessing drug dissolution characteristics using product dependent methods is simply unscientific and invalid practice. (link).

(5)    Dissolution method development: Perhaps the most wasteful of all the current practices! (link).

(6)    Current practices of drug dissolution testing using paddle/basket apparatuses – A complete waste of time! (link).

(7)    Promotion of simplicity of paddle/basket apparatuses – A marketing gimmick for scientifically useless and non-validated apparatuses (link).

(8)    Drug Dissolution Testing – A serious concern! (link).

(9)    Drug dissolution testing: Limitations of current practices and requirements (link).

(10)Dissolution Apparatuses: Compliant vs Qualified and Validated (link).

(11)Costly mistake formulators/analysts often make i.e. developing a product dependent dissolution test (link).

(12)Apparatus Calibration or Performance Verification: Misleading Conclusions and False Comfort (link).

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