Comprehensive Study of a Handheld Raman Spectrometer for the Analysis of Counterfeits of Solid-Dosage Form Medicines
Table 3
Overview of the results obtained for the validation and the tests of the second validation. () In these tests, “fail” is actually the expected answer, since these products should not be identified by the method.
Step of the method development
Sample set
Results of the identification
Validation
Validation with positive samples (e.g., product 1 tested on the method of product 1)
100% pass
Validation against all other products (e.g., product 1 tested on the method of product 2)
