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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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Comparing Manufacturing Process OptionsA techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.
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Point-of-Use Leak Testing of Single-Use Bag AssembliesThe authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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Using Flow Sensors to Monitor Process System HealthUsing flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.
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Bolstering Graduate Education and Research ProgramsAAPS supports graduate-level programs impacted by cutbacks in funding and resources.
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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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An Integrated Approach to Shipping Liquid in Single-Use SystemsIncreased use of single-use systems has led to a need to redefine safe, stable and integral systems for shipping biopharmaceuticals around the world. This article provides qualification data under international ASTM D4169 norms.
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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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Using Ultrasonic Cleaning for Equipment and ToolingUltrasonic cleaning of solid-dosage tooling and other equipment, such as filling-machine valves and nozzles, is more effective than hand cleaning.
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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.
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:
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.
