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Pharmaceutical Technology-08-02-2013
Pharmaceutical Technology
Evaluating the Pieces in Big Pharma's Manufacturing Investments
August 02, 2013
Cover Story
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The pharmaceutical majors target biologics and emerging markets in their manufacturing expansion activities and plans.
Advancing Peptide Synthesis Through Stapled Peptides
August 02, 2013
API Synthesis & Manufacturing
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Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.
Demonstrating Biosimilarity
August 02, 2013
Solutions in Pharmaceutics
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Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.
New Gene Patent Rules
August 02, 2013
BioForum
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The US Supreme Court's Myriad decision satisfied both patient groups and patent holders
Bioprocessing Advances in Vaccine Manufacture
August 02, 2013
Outsourcing Outlook
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Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
Regulatory Inspections Get Serious
August 02, 2013
Ask the Expert
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Siegfried Schmitt of PAREXEL explains how regulatory agencies are getting serious about inspections.
Seeking Harmonization in Nanomedicines Regulatory Framework
August 02, 2013
Regulation & Compliance
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Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Report from India
August 02, 2013
Global Feature
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Industry players brace themselves to face challenges as India's new drug-pricing policy kicks in full gear.
Alternative Solvents for Extractables and Leachables Evaluation
August 02, 2013
Peer-Reviewed Research
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The authors examine alternative solvents for extractables and leachables screening evaluation of process components that provide extraction equivalence and do not interfere chromatographically.
Product Spotlight: Analytical Instrumentation
August 02, 2013
In the Spotlight
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Editor's Pick's of Pharmaceutical Science & Technology Innovations: The latest in analytical instrumentation including mass spectrometers, calorimeters, and viscometers.
Regulatory Roundup
August 02, 2013
Regulation & Compliance
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Appropriate use of medications promises to improve patient care and curb spending, prompting pharmacists, public health authorities, and manufacturers to promote multiple adherence strategies.
Using Tandem LC-MS for Cleaning Validation
August 02, 2013
Troubleshooting
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The author describes how liquid chromatography-mass spectrometry works and explains some of its advantages and disadvantages, particularly compared to high-performance liquid chromatography.
Report from South Korea
August 02, 2013
Global Feature
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The bio-pharmaceutical business outlook in South Korea remains positive.
Generic Drugs Face Regulatory and Scientific Challenges
August 02, 2013
Regulation & Compliance
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FDA funds research to further development of innovative generics, while working to address review and approval issues.
Filling a Gap in Drug Safety
August 02, 2013
From The Editor
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As the Supreme Court ruled on generic-drug liability, FDA outlined new rules for warning labels.
Pharmaceutical Technology, August 2013 Issue (PDF)
August 02, 2013
Issue PDF
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Click the title above to open the Pharmaceutical Technology August 2013 issue in an interactive PDF format.