Authors
Latest:
Collaborating for Efficiency and Safety in Raw Material InspectionBy working together and taking a QA-based approach, manufacturers and suppliers can reduce raw material testing requirements.
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CDMOs: New Administration, New FrontierDespite some progress, the industry is still in a wait-and-see mode regarding the administration, Congress, and FDA.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
Latest:
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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How to Select Pharmaceutical Dust Collectors in Accordance with the New ASHRAE Standard 199The pharmaceutical industry now has a way to accurately evaluate and compare dust collection systems that are self-cleaning
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Innovations and Future Trends in HPLC Column TechnologyDevelopments in chromatography column technology to deliver greater efficiency, speed and inertness benefit the drug development process from discovery to manufacturing and quality control.
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Advancements in Extrusion-SpheronizationMore agile techniques are improving the development of multiparticulate drug-delivery systems.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
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Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability–An Industry PerspectiveA survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
Latest:
Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory TemplateA published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.
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Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough TherapiesThe primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough TherapiesThe primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
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Spectroscopy Facilitates Lean AnalysisSpectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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The Impact of AI on PharmaCPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.
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GMP Facility Modernization: Opportunities for Successful ImplementationThe DME Facility Focus survey revealed best practices for coping with the challenges of aging facilities and implementing facility modernization.
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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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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
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Combination Products: Regulatory and Patent Issues You Should Consider NowThe authors discuss regulatory and patent issues with combination products.
