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.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Rodionova OY,Balyklova KS,Titova AV,Pomerantsev ALdoi
10.1016/j.jpba.2014.05.033subject
Has Abstractpub_date
2014-09-01 00:00:00pages
186-92eissn
0731-7085issn
1873-264Xpii
S0731-7085(14)00273-8journal_volume
98pub_type
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