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Pharmaceutical Technology-05-02-2014
Pharmaceutical Technology
Extractables and Leachables Testing
May 02, 2014
Formulation
38
5
Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.
Mass Spectrometer Enhances Performance in Protein Analysis
May 02, 2014
Product Spotlight
38
5
Mass Spectrometer Enhances Performance in Protein Analysis
Data Integrity in the Analytical Laboratory
May 02, 2014
Special Feature
38
5
Data integrity in the analytical laboratory is an area of increasing focus for regulators such as FDA.
Q&A with Tony Mitchell, Pharma Tech Industries
May 02, 2014
Industry Leaders: Q&A
38
5
Tony Mitchell of Pharma Tech Industries discusses the handling and packaging of pharmaceutical powders.
Linking Drug Shortages and Quality Metrics
May 02, 2014
Insider Solutions
38
5
Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.
Achieving Zero-Order Release Kinetics Using Multi-Step Diffusion-Based Drug Delivery
May 02, 2014
Peer-Reviewed
38
5
Zero-order release of a freely water-soluble active drug can be obtained using release-controlling polymers.
EU Steps Up Inspection Efforts
May 02, 2014
Exclusive coverage from PharmTech Europe
38
5
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
Aggregation System Improves Analysis of Sub-Visible Particles
May 02, 2014
Product Spotlight
38
5
Aggregation System Improves Analysis of Sub-Visible Particles
Boosting New Antibiotic Drug Development in Europe
May 02, 2014
Exclusive coverage from PharmTech Europe
38
5
With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.
Freeze Drying Protein Formulations
May 02, 2014
Cover Story
38
5
Common challenges and key considerations when developing a freeze-drying cycle for protein pharmaceuticals.
Control Strategies for Synthetic Therapeutic Peptide APIs Part III: Manufacturing Process Considerations
May 02, 2014
Special Report
38
5
USP's Therapeutic Peptides Expert Panel discusses manufacturing processes and impurity control for synthetic peptide APIs.
Quality-Technical Agreements
May 02, 2014
Ask the Expert
38
5
Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements.
Data Management in Manufacturing
May 02, 2014
Troubleshooting
38
5
Pharmaceutical Technology spoke with Gloria Gadea-Lopez, associate director of Shire, and Martin Dittmer, PharmaSuite product manager at Rockwell Automation, about how manufacturing execution systems (MES) can improve productivity and the current challenges faced by companies implementing MES systems.
Biopharma Takes a Nervous Glance Over Its Shoulder
May 02, 2014
From The Editor
38
5
Changes are needed to maintain US biopharma innovation leadership.
Scientific Advances in Cocrystals are Offset by Regulatory Uncertainty
May 02, 2014
API Synthesis & Manufacturing
38
5
Drug developers are taking a wait-and-see approach to the use of cocrystals.
Demand for New Vaccines Spurs Innovation
May 02, 2014
Regulatory Watch
38
5
New formulations and expanded vaccine production are encouraged.
Microscope Enables High-Resolution Materials Analysis
May 02, 2014
Product Spotlight
38
5
Microscope Enables High-Resolution Materials Analysis
Stuck in Neutral
May 02, 2014
Outsourcing Outlook
38
5
The CMO industry's value proposition is limiting its market penetration.
India's Developing Market Offers Opportunities
May 02, 2014
Global Feature
38
5
Biopharma companies should not overlook India's growing market.
Laser Diffraction Software Supports Analytical QbD
May 02, 2014
Product Spotlight
38
5
Laser Diffraction Software Supports Analytical QbD
Pharmaceutical Technology, May 2014 Issue (PDF)
May 02, 2014
Issue PDF
38
5
Click the title above to open the Pharmaceutical Technology May 2014 issue in an interactive PDF format.