Authors
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
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The Role of Normal Data Distribution in Pharmaceutical Development and ManufacturingReview challenges in the use of normality testing situations and recommendations on how to assess data distributions in the pharmaceutical development manufacturing environment
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Comparing Manufacturing Process OptionsA techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.
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Penn Announces Gene Therapy Collaboration with WuXiThe University of Pennsylvania announces that it will collaborate with WuXi AppTech to research and develop gene vectors derived from recombinant viruses.
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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.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
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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A Silver-Based Disinfectant—Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy EvaluationsVarious microorganisms, including molds and bacterial spores, were tested on stainless-steel coupons and demonstrated 2–6 log reductions with one-minute wet-contact times.
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Shimadzu TOC-1000eTake ultrapure water monitoring to new heights using Shimadzu’s TOC-1000e. Benefit from a 12-month maintenance interval, resulting in reduced plant downtime, cutting calibration and revalidation effort in half.
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Complying with Revised Weighing GuidelinesThe latest revisions to the USP General Chapters <41> Balances and <1251> Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.
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How High Purity Excipients Address Parenteral Drug Formulation Challenges***Live: Tuesday, December 1, 2020 at 10am EST| 9am CST| 3pm GMT| 4pm CET***Formulators face special challenges with developing parenteral drugs to achieve the needed stability, efficacy and sterility. Learn how high purity excipients can be used to address formulation issues, while complying with regulatory requirements.*** On demand available after final airing until Dec. 1, 2021.***
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Minimizing Variation in Vial Withdrawal PracticeInnovations in drug delivery such as needle-free transfer devices and vial adapters can provide consistency when transferring liquid for reconstitution of lyophilized drug products.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based ApproachA risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.
Latest:
Don’t Gamble on Tablet Tooling MaintenanceBy following some fundamental steps, manufacturers can optimize their tablet tooling maintenance and resulting productivity.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
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.
Latest:
Injecting Highly Viscous DrugsThe author reviews the challenges in delivering macromolecule biologics.
Latest:
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.
Latest:
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.
Latest:
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?
