Quantitative risk assessment in classification of drugs with identical API content.
J Pharm Biomed Anal
; 98: 186-92, 2014 Sep.
Article
en En
| MEDLINE
| ID: mdl-24929870
ABSTRACT
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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1
Base de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
Tipo de estudio:
Etiology_studies
/
Prognostic_studies
/
Risk_factors_studies
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
2014
Tipo del documento:
Article