Pharmaceutical Technology, Oct 2, 2013 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Oct 2, 2013
Special Report: Drug Delivery
Evaluating Strategies for Oral Absorption Enhancement
By Adeline Siew, PhD
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.
Elucidating Biosimilars Characterization
By Adeline Siew, PhD
Industry experts discuss the importance of characterization studies during biosimilars development and related analytical methods.
API Synthesis & Manufacturing
Overcoming Challenges in Fluorine-Based Chemistry
By Patricia Van Arnum
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.
Helium Integrity Testing of Single-Use Vessels
By Vishwas Pethe , Alex Terentiev
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.
Peer Reviewed
A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies
By Kathleen Kelly , Nancy Lewen
The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.
Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction
By Richard J. Forsyth , Keith Bader , Kelly Jordan
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.
Packaging Forum
Maintaining and Verifying the Cold Chain
By Hallie Forcinio
Temperature-sensitive pharmaceuticals and biologics depend on a variety of services and technologies to establish, maintain, and verify proper storage and transport conditions.
Inside USP
USP Seeks Input on Standards for Plastic Packaging Systems
By Desmond Hunt
USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.
Industry Insider
Unraveling the Mystery of Ireland's Pharm-Attractions
By Barry Heavey
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.
Outsourcing Outlook
The Expense of Vision in Outsourcing
By Jim Miller
Practicality of implementation should be a part of vision in the bio/pharmaceutical industry.
Global Feature
Report from Myanmar
By Jane Wan
Foreign companies zero in on Myanmar with the hope of securing a foothold in its pharmaceutical market.
Report from: Middle East and North Africa
By Jill E. Sackman
The pharmaceutical industry grows despite conflict in the Middle East.
Regulatory Watch
FDA Seeks Metrics to Define Drug Quality
By Jill Wechsler
Manufacturing standards are considered key to preventing drug recalls and shortages.
Regulation & Compliance
Tracking Quality in Drug Manufacturing
By Patricia Van Arnum
Recent FDA enforcement activity reveals issues with vial-filling, adequacy of QA/QC procedures, particulate matter in inhalation powders and injectables, and drug labeling.
Industry Leaders: Q&A
Q&A with Amie Gehris, Dow Water and Process Solutions
Amie Gehris of Dow Water and Process Solutions discusses formulating abuse-deterrent drugs.
Ask the Expert
Ensuring Compliance with Drug Accountability Requirements
Kurt Lumsden, Director Client Services at Perceptive Informatics, a subsidiary of PAREXEL, discusses regulatory requirements for the drug accountability process.
Guest Editorial
Changing the Dynamic of CROs
By Anthony J. DeStefano, PhD
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.
Product Spotlight
LCMS-8050 Mass Spectrometer Increases Quality Analysis
By Melanie Sena
LCMS-8050 Mass Spectrometer Increases Quality Analysis
Video Capture and Synchronisation System
Video Capture and Synchronisation System
RheocalcT Software Tests Parameters and Data Collection
By Melanie Sena
RheocalcT Software Tests Parameters and Data Collection
Software Improves Monitoring of Pharmaceutical Ingredients
By Melanie Sena
Software Improves Monitoring of Pharmaceutical Ingredients


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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