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Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
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Compendium of Pharmaceutical Excipients for Vaginal FormulationsTo aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.
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Passion, Innovation, and LossAt a time when the industry is struggling with innovation, it might do well to learn a lesson from a few great innovators.
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Next-Generation Therapeutics on the HorizonDevelopments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.
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Filtration Clarification Needs in Annex 1Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.
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The Next Generation of Aseptic Processing EquipmentThe industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility.
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Moving Out of the Lab to Optimize Microbial ControlMicrobial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.
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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.
