Authors
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.
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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 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.
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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.
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Determining Comparability of Biosimilars Through Statistical ApproachesIt is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.
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Establishing Systems Suitability and Validity Criteria for Analytical Methods and BioassaysEnsuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.
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The Challenge of IDMP ComplianceHaving an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.
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Technology to the Rescue for Data Integrity Challenges?Informatics platforms and automation solutions may support efforts to improve data integrity practices.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
Latest:
An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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An Investigation of the Anomeric Stability of Lactose Powder Stored Under High Stress ConditionsThis study investigated the stability of solid lactose stored under high temperature and humidity conditions.
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Trends in On-Site Supplier AuditsResearch suggests that on-site audits are becoming less meaningful because suppliers are less willing to devote time to them.
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Overcoming the Challenges of Capsule Filling in Preclinical and Clinical StudiesThe authors discuss the challenges of capsule filling in preclinical and clinical studies.
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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.
