Quantitative risk assessment in classification of drugs with identical API content

• A new DD-SIMCA method is used to recognize counterfeit drugs.
• The approach accounts for a possible future variability in genuine medicines.
• Recognition is provided at given risks of wrong decisions (α- and β-errors).
• A new training method is suggested in case no counterfeit samples are available.
• Similar drugs of various producers can be used to simulate fakes in validation.

When combating counterfeits it is equally important to recognize fakes and to avoid misclassification of genuine samples. This study presents a general approach to the problem using a newly-developed method called Data Driven Soft Independent Modeling of Class Analogy. The possibility to collect representative data for both training and validation is of great importance in classification modeling. When fakes are not available, we propose to compose the test set using the legitimate drug's analogs, manufactured by various producers. These analogs should have the identical API and a similar composition of excipients. The approach shows satisfactory results both in revealing counterfeits and in accounting for the future variability of the target class drugs. The presented case studies demonstrate that theoretically predicted misclassification errors can be successfully employed for the science-based risk assessment in drug identification.

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