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Arora T.,Clinical Research Laboratories | Anand G.,Clinical Research Laboratories | Sharma S.,Clinical Research Laboratories | Sharma P.,Jubilant Life science | And 2 more authors.
International Journal of Pharmaceutical Sciences Review and Research | Year: 2011

The recent market withdrawal of troglitazone and the pending market withdrawal of cisapride highlight the issue of the risk vs benefit ratio of marketed pharmaceuticals. Primarily through the volunteer program for reporting of adverse events, the FDA was able to document problems for troglitazone and cisapride and, in concert with the respective manufacturers, develop prescribing and monitoring guidelines for troglitazone and cisapride. With both drugs, until the recent decision to recommend withdrawal, the FDA believed the benefits of these therapies outweighed the risks of potential adverse events. Pharmacists are among the stakeholders with the FDA, in addition to physicians, other healthcare professionals, and patients, and are key to preventing and managing the risk associated with medication use. Results from pharmaceutical care research document the intuitively known benefits of pharmacist/patient interactions. It is important for pharmacists to use the MedWatch system to report suspected adverse drug events. The FDA acknowledges that risk management of medical product use is currently not without fault and many options are under discussion for improvement, including labeling changes, and different ways to communicate with healthcare professionals and patients. Whatever changes are made, however, pharmacists will always be important to maximizing the benefit and minimizing the risks of medication use.

Dwivedi A.,Jubilant Life science | Singh B.,Jubilant Life science | Sharma S.,Jubilant Life science | Lokhandae R.S.,Jaipur National University | Dubey N.,Jubilant Life science
Journal of Pharmaceutical Analysis | Year: 2014

A highly sensitive, selective, and precise ultra-performance liquid chromatography tandem mass spectrometry method was developed and validated for simultaneous quantification of itraconazole and hydroxy itraconazole in human plasma by a single liquid-liquid extraction step. The precursor to product ion transitions of m/z 705.3/392.3, m/z 721.2/408.3 and m/z 708.2/435.4 were used to detect and quantify itraconazole, hydroxy itraconazole and itraconazole-d3 respectively. The lower limit of quantitation was found to be 0.500 ng/mL for itraconazole and 1.00 ng/mL for hydroxy itraconazole. The mean recoveries for itraconazole and hydroxy itraconazole were found to be 100.045% and 100.021%, respectively. This developed method with a chromatographic run time of 2.0 min was successfully applied to a bioequivalence study of 100 mg itraconazole capsule. © 2014 Xi'an Jiaotong University.

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