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Pharmaceutical Technology-10-02-2013
Pharmaceutical Technology
Q&A with Amie Gehris, Dow Water and Process Solutions
October 02, 2013
Industry Leaders: Q&A
37
10
Amie Gehris of Dow Water and Process Solutions discusses formulating abuse-deterrent drugs.
Unraveling the Mystery of Ireland's Pharm-Attractions
October 02, 2013
Industry Insider
37
10
Ireland?s life-sciences sector has grown significantly since the 1960s. To gain insights into the competitive edge that Ireland offers to the pharmaceutical industry, Pharmaceutical Technology Europe spoke with Barry Heavey from IDA Ireland, which is a government agency responsible for attracting pharmaceutical and biotech companies to Ireland.
Report from: Middle East and North Africa
October 02, 2013
Global Feature
37
10
The pharmaceutical industry grows despite conflict in the Middle East.
Maintaining and Verifying the Cold Chain
October 02, 2013
Packaging Forum
37
10
Temperature-sensitive pharmaceuticals and biologics depend on a variety of services and technologies to establish, maintain, and verify proper storage and transport conditions.
Ensuring Compliance with Drug Accountability Requirements
October 02, 2013
Ask the Expert
37
10
Kurt Lumsden, Director Client Services at Perceptive Informatics, a subsidiary of PAREXEL, discusses regulatory requirements for the drug accountability process.
The Expense of Vision in Outsourcing
October 02, 2013
Outsourcing Outlook
37
10
Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.
LCMS-8050 Mass Spectrometer Increases Quality Analysis
October 02, 2013
Product Spotlight
37
10
LCMS-8050 Mass Spectrometer Increases Quality Analysis
Tracking Quality in Drug Manufacturing
October 02, 2013
Regulation & Compliance
37
10
Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.
USP Seeks Input on Standards for Plastic Packaging Systems
October 02, 2013
Inside USP
37
10
USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.
RheocalcT Software Tests Parameters and Data Collection
October 02, 2013
Product Spotlight
37
10
RheocalcT Software Tests Parameters and Data Collection
Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction
October 02, 2013
Peer Reviewed
37
10
The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.
Report from Myanmar
October 02, 2013
Global Feature
37
10
Foreign companies zero in on Myanmar with the hope of securing a foothold in its pharmaceutical market.
Video Capture and Synchronisation System
October 02, 2013
Product Spotlight
37
10
Video Capture and Synchronisation System
Software Improves Monitoring of Pharmaceutical Ingredients
October 02, 2013
Product Spotlight
37
10
Software Improves Monitoring of Pharmaceutical Ingredients
A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies
October 02, 2013
Peer Reviewed
37
10
The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.
FDA Seeks Metrics to Define Drug Quality
October 02, 2013
Regulatory Watch
37
10
Manufacturing standards are considered key to preventing drug recalls and shortages.
Helium Integrity Testing of Single-Use Vessels
October 02, 2013
Troubleshooting
37
10
The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.
Changing the Dynamic of CROs
October 02, 2013
Guest Editorial
37
10
Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.
Elucidating Biosimilars Characterization
October 02, 2013
BioForum
37
10
Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.
Evaluating Strategies for Oral Absorption Enhancement
October 02, 2013
Special Report: Drug Delivery
37
10
Scientists from the CDMO Metrics talk about the challenges in developing oral formulations for poorly permeable drugs and the strategies used to enhance oral absorption in the gastrointestinal tract.
Tablet-Sticking Solutions
October 02, 2013
37
10
Analytical methods are being used to troubleshoot tablet-sticking problems and to develop screening methods and predictive models to more quickly find solutions.
Overcoming Challenges in Fluorine-Based Chemistry
October 02, 2013
API Synthesis & Manufacturing
37
10
Fluorinated molecules play an important role as pharmaceutical compounds. Recent advances seek to overcome the challenges of selective and late-stage insertion of fluorine into small molecules.
Pharmaceutical Technology, October 2013 Issue (PDF)
October 02, 2013
Issue PDF
37
10
Click the title above to open the Pharmaceutical Technology October 2013 issue in an interactive PDF format.