Rashmikant B. Shah

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Process analytical technology (PAT) has been gaining momentum in the biotech community due to the potential for continuous real-time quality assurance resulting in improved operational control and compliance. In this two part series, we address PAT as it applies to processes that produce biotech therapeutic products. In the first part, we address evolution(More)
Implementing real-time product quality control meets one or both of the key goals outlined in FDA's PAT guidance: "variability is managed by the process" and "product quality attributes can be accurately and reliably predicted over the design space established for materials used, process parameters, manufacturing, environmental, and other conditions." The(More)
BACKGROUND Dysfunctional mitochondrial processes limit malignant cells ability to use energy from fatty acids and ketones. Animal studies using ketogenic diets for cancer show encouraging results. We tested the diet's safety and feasibility in cancer patients across a broad variety of solid tumors. METHODS We recruited 17 advanced cancer patients who were(More)
Photostimulable storage phosphor (PSP) image acquisition systems have been available for several years. The technology has had the opportunity to mature; however, there has not been an independent comparison of recently marketed commercial systems. For this study, three computed radiography (CR) systems using PSP technology (Kodak CR System 400 with(More)
Traditionally, post-production culture harvest capture of therapeutic monoclonal antibodies (mAbs) is performed using Protein A chromatography. We investigated the efficiency and robustness of cation exchange chromatography (CEX) in an effort to evaluate alternative capture methodologies. Up to five commercially available CEX resins were systematically(More)
Radiographic correlation is essential for many of the examinations performed in nuclear medicine. The purpose of this study was to evaluate the impact of a picture archiving and communications system (PACS) on the function and efficiency of a nuclear medicine department at a tertiary care institution. We evaluated 250 consecutive noncardiac nuclear medicine(More)
Adamantinoma is a rare low-grade malignant bone tumor of epithelial origin. Metastatic adamantinoma has been reported to be resistant to chemotherapy. We report a case of metastatic adamantinoma to the lung, 10 years after the initial diagnosis of tibial mass. The patient received radiation therapy to the lung with partial response. A surveillance PET scan(More)
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