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Latest:
System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and ApplicationsTesting of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and ApplicationsTesting of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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Hydrogels for the Controlled Release of Pharmaceutical ProteinsTwo types of hydrogels used in parenteral protein-delivery systems offer opportunities for achieving a variety of prolonged- and delayed-release patterns.
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System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and ApplicationsTesting of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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Filter Integrity Testing in Liquid Applications, Revisited Part IIIn the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.
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Laboratory Equipment QualificationA summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
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Laboratory Equipment QualificationA summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
Latest:
Laboratory Equipment QualificationA summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
Latest:
Filter Integrity Testing in Liquid Applications, Revisited Part IIIn the concluding part of this article, the authors address diffusive-airflow imprecisions and measurements as well as automated integrity-test equipment, variations in bubble-point measurements, and the identification of a "sterilizing" filter.
Latest:
Laboratory Equipment QualificationA summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
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Determining Water Content with a Novel Karl Fischer Titration ApproachA new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.
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Identifying TPPs and CQAs for a Lyophilized Parenteral ProductQuality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
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Identifying TPPs and CQAs for a Lyophilized Parenteral ProductQuality by design highlights product and process understanding and control, integrating quality risk management, and is also considered a quality system for managing a product’s lifecycle.
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A Novel Amorphous Delivery System to the Skin for Poorly Soluble ActivesDrugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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A Novel Amorphous Delivery System to the Skin for Poorly Soluble ActivesDrugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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A Novel Amorphous Delivery System to the Skin for Poorly Soluble ActivesDrugs in the amorphous form are loaded into porous silica particles, which provide a maintained concentration gradient for skin delivery.
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A Perspective on Computer ValidationThis article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.
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Liposomes, Part II: Drug delivery systemsNon-toxic and biodegradeable, biologically active liposomes encapsulate therapeutics to provide an attractive drug delivery system for the future.
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Liposomes, Part II: Drug delivery systemsNon-toxic and biodegradeable, biologically active liposomes encapsulate therapeutics to provide an attractive drug delivery system for the future.
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Liposomes, Part II: Drug delivery systemsNon-toxic and biodegradeable, biologically active liposomes encapsulate therapeutics to provide an attractive drug delivery system for the future.
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Partnership Models Structure R&D ChangePharmaceutical companies are adopting multiple choice partnership strategies to meet the challenges of today's R&D instead of being focused primarily on internal development.
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Identifying and Solving Scale-up Challenges in the Synthesis and Formulation of Small-Molecule APIsJoin expert Peter Poechlauer to understand the essentials of API process development to ensure a smooth pathway for scale up. Live: Thursday, Sept. 12, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 12, 2020 Register free
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Maintaining GxP with a 21 CFR Part 11-Compliant Tracking SystemIncorporating the right quality-management tool can facilitate Part 11 compliance.
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Maintaining GxP with a 21 CFR Part 11-Compliant Tracking SystemIncorporating the right quality-management tool can facilitate Part 11 compliance.
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Establishing Compliance of Batch SCADA Systems with FDA CGMP 21 CFR Part 11Batch SCADA systems are assessed for regulatory compliance and functionality.
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Toward Twenty-First-Century Sales and Operations PlanningBusiness models, processes, and planning technology must be current to allow companies to replan quickly and remain competitive.
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Tablet Relaxation and Physiocomechanical Stability of Lactose, Microcrystalline Cellulose, and Dibasic Calcuim PhosphateThe authors discuss the physiocomechanical characteristics of three commonly used pharmaceutical excipients and describe the effects of variables on their physiocomechanical stability.
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Toward Twenty-First-Century Sales and Operations PlanningBusiness models, processes, and planning technology must be current to allow companies to replan quickly and remain competitive.
