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Pharmaceutical Technology-09-02-2013
Pharmaceutical Technology
The Importance of Continued Investment in R&D
September 02, 2013
Guest Editorial
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There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.
FDA Works to Secure Drug Supply Chain
September 02, 2013
Regulation & Compliance
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New FDA supply chain policies aim to strengthen inspection and oversight processes.
Outsourcing Partnerships for CMC Development
September 02, 2013
Outsourcing
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Are strategic partnerships in clinical research a model for CMC services?
MF40 Automated Punch and Die Polishing Machine
September 02, 2013
Product Spotlight
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I Holland has introduced the next generation to its range of MF polishers, the MF40 automated punch, and die polishing machine.
Quality by Design in APIs
September 02, 2013
Cover Story
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The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs
Connecting People, Science, and Regulation
September 02, 2013
Guest Editorial
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PDA/FDA regulatory conference promotes a commitment to quality.
Effective and Efficient Weighing of Potent Compounds
September 02, 2013
Peer-Reviewed Research
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The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
EU Raises API Standards: A Curse in Disguise?
September 02, 2013
Regulation & Compliance
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The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
The Importance of Characterization in Biosimilars Development
September 02, 2013
Featured Content
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Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.
Omega Design Corporation Introduces LabelSync 450
September 02, 2013
Product Spotlight
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Omega Design Corporation offers the LabelSync 450 Vision Module, designed to capture and sync a bottle?s unique serialized label with its individual line code.
Bosspak VTC 100 Tablet and Capsule Counter
September 02, 2013
Product Spotlight
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The Bosspak VTC 100 electronic tablet and capsule counter from Romaco?s is designed to fill pharmaceutical solids or food supplements into bottles at high speed.
Best Practices for Restricted Access Barrier Systems
September 02, 2013
Troubleshooting
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Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
The Basics of Measurement Uncertainty in Pharma Analysis
September 02, 2013
Statistical Solutions
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How good is a reportable value?
Report from Brazil September 2013
September 02, 2013
Global Feature
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Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
XstalBio Introduces CentuRecon
September 02, 2013
Product Spotlight
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CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.
Multivariate Approaches for Powder Characterization
September 02, 2013
Ask the Expert
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John Yin, an applications specialist with Freeman Technology, discusses the importance of powder-characterization techniques for optimizing pharmaceutical product development and manufacturing processes.
The Elements of Training
September 02, 2013
Insider Solutions
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Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Overcoming Limitations of Vaporized Hydrogen Peroxide
September 02, 2013
Peer-Reviewed Research
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Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.
Advancing Chiral Chemistry in Pharmaceutical Synthesis
September 02, 2013
API Synthesis & Manufacturing
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Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.
Pharmaceutical Technology, September 2013 Issue (PDF)
September 02, 2013
Issue PDF
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Click the title above to open the Pharmaceutical Technology September 2013 issue in an interactive PDF format.