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Pharmaceutical Technology-02-02-2015
Pharmaceutical Technology
Hiden Analytical Combination Spectrometer Increases Repeatability
February 02, 2015
Product Spotlight
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Hiden Analytical’s Catlab PCS is a microreactor combined with a mass spectrometer system to characterize and evaluate catalysts while completing general thermal studies.
Ross Disperser Maintains Consistency
February 02, 2015
Product Spotlight
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Ross Bow Tie Dispersers, or High Viscosity Dispersers, are heavy-duty mixers designed for heavy pastes and viscous liquids.
Radio Frequency Dryer Improves Efficiency
February 02, 2015
Product Spotlight
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Radio Frequency’s Macrowave Dryers feature volumetric heating, moisture reduction, shortened dwell times, and keep temperature uniform throughout temperature-sensitive materials.
FANUC Robot Enhances Cycles Per Second
February 02, 2015
Product Spotlight
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FANUC’s M-1iA delta robot is designed for bottling lines with the capability of operating at 120 cycles per second.
Preventing Tablet Tooling Problems
February 02, 2015
Troubleshooting
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Tooling can be damaged by poor handling or problems in process design or material choice.
Chiral Resolution with and without Resolving Agents
February 02, 2015
API Synthesis and Manufacturing
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Resolution technologies remain crucial for commercial-scale chiral API production.
FDA Sets Agenda for 2015 Guidance Development
February 02, 2015
FDA Report
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Biosimilars, supply chain security, quality metrics, and elemental impurities headline guidance topics on FDA’s 2015 agenda.
Cures Require Compromise
February 02, 2015
From The Editor
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Initiatives to speed drug development must pass Congress and special interest groups.
Ligand-Binding Assays and the Determination of Biosimilarity
February 02, 2015
Biologics Product Quality
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Ligand-binding assays are fundamental to characterizing biosimilars.
Labeling of Biosimilars
February 02, 2015
Regulatory Watch
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EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
FDA Sets Policies to Enhance Drug Security and Safety
February 02, 2015
Regulatory Watch
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Manufacturers face new rules for tracing drugs through the supply chain and compounders face stricter standards.
Gauging the CMO Biosimilar Opportunity
February 02, 2015
Outsourcing Outlook
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Market forces may limit the success of CMOs.
Finding Opportunities in Brazil
February 02, 2015
Global Market Report
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Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.
Enhancing Dissolution of Poorly Soluble Drugs through Jet-Milling
February 02, 2015
Formulation
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The authors discuss a novel particle engineering technology based on mechano-chemical activation.
In-Vivo Release Studies of Levamisole Phosphate and Ivermectin from an Isotropic Medium-Chain Mono and Diglyceride-Based Formulation Following Subcutaneous Injection in Sheep
February 02, 2015
Peer-Reviewed Research
39
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Formulating an injectable solution containing both hydrophilic and hydrophobic drugs is a challenge.
Developing and Validating Assays for Small-Molecule Biomarkers
February 02, 2015
Cover Story
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Working with biological matrices and understanding the intended use are crucial.
The New 2014 IPEC Significant Change Guide
February 02, 2015
Inside IPEC
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This article gives an overview of the concept and contents of the revised guidance and outlines how it has changed from the previous version.
Reinventing the Cold Chain in a High-Stakes Market
February 02, 2015
Cold Chain
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Market changes are driving pharmaceutical companies to consider new ways to mitigate risk in the cold chain.
Special Considerations for Extractables and Leachables Testing in Biological Products
February 02, 2015
Extractables and Leachables
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New guidelines focused on the materials of construction in biologic therapy packaging will help vendors prepare comprehensive extractable and leachable testing strategies.
Improving Visual Inspection Practices
February 02, 2015
Visual Inspection
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New guidelines and best practices may lead to improved quality and reduced recalls due to visual defects.
Industry Expert Q&A with Robin Hooker
February 02, 2015
Industry Leaders
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Robin Hooker the Director of Healthcare Sector Marketing at UPS discusses issues with maintaining the cold chain in developing markets.
Pharmaceutical Technology, February 2015 Issue (PDF)
February 02, 2015
Issue PDF
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Click the title above to open the Pharmaceutical Technology February 2015 issue in an interactive PDF format.