September 2016
Volume 40, No. 9 |
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| FOCUS |
Agnes Shanley
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
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| PEER-REVIEWED RESEARCH |
Richard J. Forsyth
Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
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| MANUFACTURING AUTOMATION |
Jennifer Markarian
In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
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| FACILITY RENOVATION |
Eric Bohn
Renovating a facility requires careful design and a plan to minimize production interruption.
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PharmTech September Issue
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PharmTech's September 2016 Special Issue
Be sure to check out this month's APIs, Excipients, and Manufacturing special issue for articles on data integrity, topical formulations, API manufacturing, and more!
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| MODULAR MANUFACTURING |
Caroline Hroncich
Industry experts discuss recent trends in modular manufacturing.
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| TOPICAL DRUG APPROVALS |
Rong-Kun Chang, Pahala Simamora, Bing Cai, Andre Raw, Susan Rosencrance
Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.
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| QUALITY |
Gretchen L. Shearer, PhD
Visual inspection of parenteral vials is the first step in a root cause investigation.
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| FORMULATION |
Melina Figueiredo, Diana M. Leite, Aikaterini Lalatsa
Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.
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| TROUBLESHOOTING |
Paul McClune
A process-specific preventative maintenance program improves productivity and reliability.
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| REGULATORY WATCH |
Jill Wechsler
Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
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The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
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| OUTSOURCING|
Jim Miller
The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
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| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
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| FROM THE EDITOR |
Rita C. Peters
Steep price increases for a popular drug have created patient and Congressional backlash.
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| PRODUCT SPOTLIGHT |
Tumble Blenders from Ross, Charles & Son now come standard with motors equipped with a electro-magnetic brake.
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The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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The OM-CP-CRYO-TEMP ultra-low temperature data logger from Omega Engineering records temperatures as low as -86 °C.
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The FlowCam ALH automated liquid handling system from Fluid Imaging Technologies is a particle imaging and analysis system that automatically detects, images, and characterizes individual particles and microorganisms.
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| Events |
September 18–21, 2016
September 26–28, 2016
October 4–6, 2016
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