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.


CONCLUSIONS
A clearer description of the procedures would undoubtedly increase the quality of papers in this area.
a Department of Biopharmacy , Medical University of Łódź, Łódź , Poland.
Magdalena
M
Jasińska-Stroschein
a Department of Biopharmacy , Medical University of Łódź, Łódź , Poland.
Urszula
U
Kurczewska
a Department of Biopharmacy , Medical University of Łódź, Łódź , Poland.
Daria
D
Orszulak-Michalak
D000704:Analysis of Variance; D002623:Chemistry Techniques, Analytical / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D065546:Drug Liberation; D010506:Periodicals as Topic; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012995:Solubility; D054928:Validation Studies as Topic
D004364:Pharmaceutical Preparations
Dissolution checklist; dissolution study; reporting errors