Objective: This work aimed to explore the possibility of using Fourier-transform infrared (FTIR) spectroscopy and chemometrics to develop multivariate models to authenticate the "halal-ity" of pharmaceutical excipients with controversial halal status (e.g., magnesium stearate).
Materials and Methods: The FTIR spectral fingerprints of the substance were used to build principal component analysis (PCA) models. The effects of different spectral pretreatment processes such as auto-scaling, baseline correction, standard normal variate (SNV), first, and second derivatives were evaluated. The optimization of the model performance was established to ensure the sensitivity, specificity, and accuracy of the predicted models.
Results: Significant peaks corresponding to the properties of the compound were identified. For both bovine and plant-derived magnesium stearate, the peaks associated can be seen within the regions 2900cm-1 (C-H), 2800cm-1 (CH3), 1700cm-1 (C=O), and 1000-1300cm-1 (C-O). There was not much difference observed in the FTIR raw spectra of the samples from both sources. The quality and accuracy of the classification models by PCA and soft independent modeling classification analogy (SIMCA) have shown to improve using spectra optimized by first derivative followed by SNV smoothing.
Conclusion: This rapid and cost-effective technique has the potential to be expanded as an authentication strategy for halal pharmaceuticals.
Objective: The aim of this study was to conduct a cost-effectiveness analysis of spending on healthcare R&D to address the needs of developing innovative therapeutic products in Indonesia.
Methods: A decision tree model was developed by taking into account four stages of R&D: stage 1 from raw concept to feasibility, stage 2 from feasibility to development, stage 3 from development to early commercialization, and stage 4 from early to full commercialization. Considering a 3-year time horizon, a stage-dependent success rate was applied and analyses were conducted from a business perspective. Two scenarios were compared by assuming the government of Indonesia would increase GERD in health and medical sciences up to 2- and 3-times higher than the baseline (current situation) for the first and second scenario, respectively. Cost per number of innovative products in health and medical sciences was considered as the incremental cost-effectiveness ratio (ICER). Univariate sensitivity analysis was conducted to investigate the effects of different input parameters on the ICER.
Results: There was a statistically significant association (P-value<0.05) between countries' GERD in medical and health sciences with the number of innovative products. We estimated the ICER would be $8.50 million and $2.04 million per innovative product for the first and second scenario, respectively. The sensitivity analysis showed that the success rates in all stages and total GERD were the most influential parameters impacting the ICER.
Conclusion: The result showed that there was an association between GERD in medical and health sciences with the number of innovative products. In addition, the second scenario would be more cost-effective than the first scenario.