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Pharmaceutical Technology-11-02-2013
Pharmaceutical Technology
Report from Brazil November 2013
November 02, 2013
Global Feature
37
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New regulation offers patients in Brazil greater access to experimental drugs.
Applying Catalysis to Optimize API Synthesis
November 02, 2013
API Synthesis & Manufacturing
37
11
Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.
Predicting Long-Term Storage Stability of Therapeutic Proteins
November 02, 2013
Peer Reviewed
37
11
Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.
Control of Elemental Impurities
November 02, 2013
Inside EDQM
37
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The European Pharmacopoeia Commission has decided to change its approach on elemental impurities.
Automation System Improves Operational Insight
November 02, 2013
Product Spotlight
37
11
Automation System Improves Operational Insight
Disposable Applications in Demand by Biopharma
November 02, 2013
Outsourcing Outlook
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Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.
Solvent-Free Coating of Traditional and User-Friendly Dosage Forms
November 02, 2013
Solutions in Pharmaceutics
37
11
The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.
Congress Revises Rules for Drug Compounding and Supply-Chain Security
November 02, 2013
Regulatory Watch
37
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Legislators agree on a limited bill affirming FDA authority over compounders while setting up a process for national drug tracking.
Can Pharma Defy Gravity at the Patent Cliff?
November 02, 2013
Cover Story
37
11
Pharmaceutical companies are using formulation strategies as a lifecycle management tool to maximize product value and preserve their revenue streams.
Defining and Presenting Overkill Cycle Validation
November 02, 2013
Troubleshooting
37
11
Sterilization validation must be based on a robust, quality-by-design philosophy; autoclave overkill cycles should be validated by correlating lethality data to support chosen critical process parameters, even when using overkill sterilization.
Preparing for Patent Expiry
November 02, 2013
37
11
Pharmaceutical companies have long recognized the need to protect their market position long before their products come off patent. Pharmaceutical Technology spoke to Neal Hansen, managing director of the consulting firm, Hansen Strategy, about key considerations in product lifecycle management
Wireless Network Monitors Air Cooled Heat Exchanger
November 02, 2013
Product Spotlight
37
11
Wireless Network Monitors Air Cooled Heat Exchanger
Database Improves Process Efficiency
November 02, 2013
Product Spotlight
37
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Database Improves Process Efficiency
System Links Packaging Operations
November 02, 2013
Product Spotlight
37
11
System Links Packaging Operations
European Union Introduces GMPs for Excipients
November 02, 2013
Regulatory Watch
37
11
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
Compliance in Quality Systems
November 02, 2013
Ask the Expert
37
11
Siegfried Schmitt of PAREXEL discusses regulation requirements for quality systems.
New Funding and Approval Pathways Prove Popular
November 02, 2013
From The Editor
37
11
The JOBS Act and FDASIA show early signs of accelerating drug development.
Pharmaceutical Technology, November 2013 Issue (PDF)
November 02, 2013
Issue PDF
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Click the title above to open the Pharmaceutical Technology November 2013 issue in an interactive PDF format.