Verification of supplies for double-blind clinical studies

3 Verification of supplies for double-blind clinical studies 

In two papers, Ritchie [39,40] described an approach for performing qualitative NIR analysis of clinical samples with a concern for current good manufacturing practices (cGMPs). Since clinical lots are often ad hoc formulations, it is difficult to generate a discriminant equation prior to the actual clinical trial. Ritchie et al. developed a procedure whereby equations are quickly generated for any particular study, then discarded. 

Using the first configuration, all but the 2% tablets were easily classified the 2% tablets could not be differentiated from placebo samples. With the second and third configurations, only 10 and 20% tablets, placebo, and clinical comparator tablets could be properly classified. 

Another application of NIR in the analysis of clinical batches was published in 1994 by Aldridge et al. [42]. A NIRSystems Model 6500 spectrometer with a custom sampling configuration was used for spectral collection from the blister-packed samples. In 1998, Candolfi et al. [43] combined pattern recognition techniques with NIR spectroscopy to identify samples 

Pharmaceutical and medical applications of near-infrared spectroscopy 

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C. Verification of Supplies for Double-Blind Clinical Studies... 

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