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Using Structural Equation Modeling (SEM) for the Study of Impurity Profiles of Drug Substances

Summary: [This abstract is based on the authors' abstract.]The impurity profile is an important quality characteristic of a drug substance, but it is not always feasible to determine the chemical structure of all impurities because of extremely low concentrations found in the drug. A previous study produced a hypothesis for explaining the origin of unidentified impurities of a drug substance, but there is concern that alternative hypotheses might accurately explain the phenomenon as well. The application of recent developments in structural equation modeling is explored for the systematic generation and selection of hypotheses to be considered for further chemical research.

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  • Topics:
  • Keywords: Hypothesis testing,Pharmaceutical industry,Analytical modeling
  • Author: Gonzalez-de la Parra, Mario; Rodriguez-Loaiza, Pilar; Namur, Salvador
  • Journal: Quality Engineering