October 2016
Volume 40, No. 10 |
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| FOCUS |
Adeline Siew, PhD
Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.
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| PEER-REVIEWED RESEARCH |
David W. Osborne
This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.
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| PRODUCT QUALITY |
Karen A. Bernard, PhD, Avin S. Lalmansingh, Ph.D., Anurag Sharadendu, PhD,Rajendra Uppoor, PhD, Paul Schwartz, PhD, Bing Cai, Wiley A. Chambers, Andre Raw
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
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PharmTech October Issue
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| ANTICOUNTERFEITING |
Agnes Shanley
As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
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Agnes Shanley
A number of organizations have analyzed and estimated the size of pharma's counterfeit and diversion problem.
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| QUALITY: RESIDUAL IMPURITIES |
Cynthia A. Challener
Multiple methods are required for detecting and removing protein impurities.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.
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| FORMULATION |
Sarah Dexter, Alex Slowey
Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.
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| TROUBLESHOOTING |
Sharon Nowak
Designing loss-in-weight feeders for accurate and consistent refill is crucial to a continuous solid-dosage process.
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| REGULATORY WATCH |
Jill Wechsler
Efforts to accelerate drug development will alter fee structure and require ready production sites.
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Sean Milmo
Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.
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| OUTSOURCING |
Eric S. Langer
This key bioprocessing segment is expecting continued growth.
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| PACKAGING FORUM |
Hallie Forcinio
Primary packaging and manufacturing technologies minimize product/package interaction, protect quality, support safe travel through the supply chain, and enhance performance at point of use.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
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| FROM THE EDITOR |
Rita Peters
The editors seek drug development experts to contribute technical articles for 2017.
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| PRODUCT SPOTLIGHT |
The CELLdisc from Greiner Bio-One is a multilayer cell culture vessel that offers a growth area of up to one square meter for adherent mammalian cells.
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The Double Planetary Mixers from Ross, Charles & Son are offered in 4-, 5-, 10-, and 25-gallon models for pilot-scale production of highly-filled pastes, dough-like materials, shear-sensitive gels, granulations, and powder blends.
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The Print & Check Flex Machine from Antares Vision is a flexible high-capacity serialization unit created for track and trace.
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The aCOLade 2 Manual Colony Counter from Synbiosis includes automatic count recording.
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| Events |
November 7–8, 2016
November 13–17, 2016
November 16, 2016
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