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New FDA Guidance on Electronic Common Technical Document SubmissionsNew FDA Guidance on Electronic Common Technical Document Submissions
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Industry Perspectives and Practices on PUPSITPDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.
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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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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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Effects of Polyethylene Glycol on Morphology, Thermomechanical Properties, and Water Vapor Permeability of Cellulose Acetate-Free FilmsThe authors provide a systematic evaluation of the effects of solvent systems, PEG molecular weight, and concentration of CA to PEG on the thermomechanical properties and permeabilities of CA-free films.
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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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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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Current Status of the Oral Delivery of InsulinInsulin is one of the most popular proteins to be studied for oral delivery. The authors review the current status of the development strategies of insulin drug delivery systems, the various challenges associated with these systems, and how these challenges may be overcome.
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A Path to Quality and ComplianceA new book explains process analytical technology, drug stability, and quality.
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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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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.
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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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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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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.
