Errors in reporting on dissolution research: methodological and statistical implications.

OBJECTIVE

In vitro dissolution testing provides useful information at clinical and preclinical stages of the drug development process.

METHODS

The study includes pharmaceutical papers on dissolution research published in Polish journals between 2010 and 2015. They were analyzed with regard to information provided by authors about chosen methods, performed validation, statistical reporting or assumptions used to properly compare release profiles considering the present guideline documents addressed to dissolution methodology and its validation.

RESULTS

Of all the papers included in the study, 23.86% presented at least one set of validation parameters, 63.64% gave the results of the weight uniformity test, 55.68% content determination, 97.73% dissolution testing conditions, and 50% discussed a comparison of release profiles. The assumptions for methods used to compare dissolution profiles were discussed in 6.82% of papers. By means of example analyses, we demonstrate that the outcome can be influenced by the violation of several assumptions or selection of an improper method to compare dissolution profiles.

DISCUSSION AND CONCLUSION

A clearer description of the procedures would undoubtedly increase the quality of papers in this area.