Authors
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Investigation of Various Impurities in FebuxostatFebuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
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Injecting Highly Viscous DrugsThe author reviews the challenges in delivering macromolecule biologics.
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Using Quality by Design to Develop Robust Chromatographic MethodsThe quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
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Evaluating Progress in Analytical Quality by DesignThe authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.
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Trends in Tablet ToolingTool coatings are now seen as an acceptable means of solving production problems, such as sticking and corrosion, resulting in increased product yield.
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Ireland: The Gateway to Biopharma's FutureDespite recent changes in corporate tax law, Ireland remains a valuable and attractive partner in the development and manufacture of biopharmaceuticals.
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Should Pharmaceutical Companies be Putting their Heads in the Cloud?Despite concerns over regulation and data protection, cloud computing is entering the world of pharmaceuticals. There are good reasons why the cloud might suit pharmaceutical companies-greater efficiency, lower costs, the ability to take data in the public domain and mesh it with private data sets-all good reasons to embrace the cloud. But, assuming that the regulatory concerns can be overcome, is the cloud what it appears to be?
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Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological IndicatorsIn anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.
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Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological IndicatorsIn anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.
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Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological IndicatorsIn anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.
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Reflecting on 35 Years of Procurement TransformationThe past three decades have driven a purchasing evolution to a procurement revolution.
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A Next Generation of Quality ManagementThe author proposes a quality management system that uses the power of executive management to promote a positive quality culture.
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The Advantages Of A Web-Based SystemDr. Fred Jordan, CEO at AlpVision SA, explains how web-based server solutions can aid anticounterfeiting strategies and why such systems are seeing increased uptake.
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Advances in Film CoatingFilm coating for solid oral dosage forms provide important patient benefits while enhancing brand recognition and adding value to innovator, generic, over-the-counter and nutritional products.
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Understanding Fluidized-Bed GranulationThis study demonstrates the beneficial use of a spatial-filter velocimetry particle-size analyzer during granulation.
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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Controlling NucleationIdeally, all product formulations should experience the same conditions when it comes to lyophilisation, but in practice, however, nucleation can occur.
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Surface Neutralization SystemA new, robust method for protein elution from ceramic hydroxyapatite.
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FDA Adopts Final Version of Q11 GuidanceFDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.
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Thermal Analysis with Pharmaceutical ApplicationsUse of thermal analysis techniques to characterize pharmaceutical products.
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HPAPIs And BioconjugatesThe market for HPAPIs is growing rapidly with the research industry's emphasis on oncology.
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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.
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Controlled Crystallization During Freeze-DryingThe authors discuss the preparation of lipophilic drug nanocrystals by controlled crystallization during freeze-drying.
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Intervention Risk Evaluation and Management in Aseptic Manufacturing–Part IIIREM can be used for effectively assessing and mitigating risks and improving the overall sterility assurance level in all types of aseptic processing lines.
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Managing Information OverloadCompanies know they need regulatory information management, but they don't always know where to start and how to weave this capability across diverse technology applications.
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Addressing Segregation of a Low-Dosage Direct BlendThe authors modified equipment and the manufacturing process to re-establish content uniformity among tablets.
