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Latest:
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.
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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.
Latest:
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.
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Inside the Lab of the FutureDrive growth by establishing integrated, AI-fueled lab systems and a data-driven corporate culture that’s ready and resilient, no matter what business challenges emerge tomorrow. Evolving to a Lab of the Future takes the right technologies, systems, and expert guidance.
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A Three-Step Path Toward Combination Product ApprovalThis article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.
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Reliability Rooms and the Move to Proactive Supply Chain ManagementCross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.
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Approaches to USP OTC Monograph ModernizationThe authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
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Approaches to USP OTC Monograph ModernizationThe authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
Latest:
Approaches to USP OTC Monograph ModernizationThe authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
Latest:
Approaches to USP OTC Monograph ModernizationThe authors hope to facilitate further collaboration among all the stakeholders for USP OTC Monograph Modernization with the goal of identifying a satisfactory approach for USP, FDA, and industry.
