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Nitrosamines, Elemental Impurities, Extractables, and Leachables: The Pharma Industry’s New NormalVarious impurities can infiltrate the container closure system in pharmaceutical manufacturing. Understanding nitrosamines, elemental impurities, extractables, and leachables can help ensure the safety of the final product.
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The Role of Powder Characterization in Continuous ManufacturingExperimental work on wet granulation demonstrates the use of dynamic powder characterization to support continuous processing for tablet manufacturing.
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Does Your Clinical Trial Design Satisfy the Needs of Your Patients?*** Live: Thursday, November 5, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET***At the center of every clinical trial is a patient awaiting treatment. Learn from the experts on how to design a decentralized clinical trial to improve patient recruitment and retention. ***On demand available after final airing until Nov. 5, 2021***
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Filtration in Dissolution Testing: Improving Throughput and Reducing VariabilityWednesday, June 30, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST
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Long acting PLGA complex parenterals and IVIVC developmentWebinar Date/Time: Wed, Mar 26, 2025 1:30 PM EDT
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Maintaining Thermal Fluid SystemsPreventative maintenance of heat transfer fluid systems is important for reducing downtime in pharmaceutical manufacturing.
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Taking a Holistic Approach for Data GovernanceAs regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
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Taking a Holistic Approach for Data GovernanceAs regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
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Taking a Holistic Approach for Data GovernanceAs regulatory authorities crack down on data integrity violations, bio/pharma companies must ensure adequate data governance programs are in place.
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Impact of Non-Compliance on the American Healthcare ConsumerGMP non-compliance can spill over and impact patient access to life-saving medications.
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Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control ChartIn Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control ChartIn Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and BetterTraditional project decision-making is compared with a QbD approach.
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Does Your Endotoxin Detection Method Ensure Patient Safety?Understanding the relative strengths and weaknesses of different endotoxin test methods is crucial to maintaining quality and patient safety.
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Selecting the Appropriate Technology for Oral Bioavailability EnhancementModel-based formulation and technology selection methodologies facilitate rapid product development.
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Evaluating Drug Substance–Drug Product Interplay Accelerates DevelopmentInnovative approaches to drug screening—such as evaluation to identify the optimal solid state of a molecule and in-vitro characterization to establish the optimal solid state of a molecule and the ideal bioavailability-enhancing technology—can help drug developers meet accelerated development timelines while managing risk.
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The Value of LMS in Driving Effective Risk Mitigation Principles through QMS and QRMInvesting in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.
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Innovation And R&D In Freeze-DryingLyophilisation or freeze-drying is widely used in the pharmaceutical industry for a variety of reasons.
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Best Weighing Practices in the Pharmaceutical IndustryUnderstanding what affects a measurement and implementing appropriate procedures will aid weighing accuracy.
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Using Human Challenge Trials to Develop Flu VaccinesChallenge trials may increase in coming years as new and improved challenge agents better emulate “natural” disease states.
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Designing and Operating Flexible, High-Containment Vaccine ManufacturingA new facility type integrates next-generation mobile cleanroom systems.
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Moving to Closed Systems for Aseptic ProcessingAlternatives to time-consuming, error-prone operations promise to reduce vaccine manufacturing costs and improve facility flexibility.
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Achieving Intensification and Flexibility in Virus Purification with Next-Generation Chromatography ToolsThis article discusses the potential of using high-productivity membrane chromatography to achieve intensified and flexible virus manufacturing.
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Achieving Intensification and Flexibility in Virus Purification with Next-Generation Chromatography ToolsThis article discusses the potential of using high-productivity membrane chromatography to achieve intensified and flexible virus manufacturing.
