Quality in, Quality Out
A book guides readers through the regulatory requirements for computerized quality systems.
Quarantine at a Glance
A successful quarantine program requires collaboration among all departments of a pharmaceutical facility.
Drug Serialization and Supply-Chain Security
As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.
Initial Solvent Screening of Carbamazepine, Cimetidine, and Phenylbutazone: Part 2 of 2
The authors describe the importance of a rapid and an abbreviated screening strategy in initial solvent screening. This article contains bonus online-exclusive material.
Pharmacosomes: A Potential Alternative to Conventional Vesicular Systems
Pharmacosomes can pass through biomembranes efficiently and possess several advantages over traditional vesicular drug-delivery systems.
Package Design Boosts Patient Compliance
Compliance features help patients follow medication regimens correctly.
Truth and Transparency
Misleading the public about their investments-be it money or medicine-is unacceptable.
Outsourcing Clinical Trial Materials
CROs and CMOs expand to gain a piece of the market for clinical trial materials.
Penny-Wise, Pound-Foolish
Pharma companies that sell redundant facilities could endanger their supply chains.
Mapping Opportunities for Patent Positions
Follow-on biologics could unleash the potential of several industries and may even spark economic recovery.
Beneath the Surface
It can take a lot of work to make sure nothing happens.
Operator Error
Short-term problems in software or hardware lead to long-term manufacturing troubles.
Charting a Pathway to Follow-On Biologics
Debates about science, manufacturing, and European regulations will shape the approval process for follow-on biologics in the United States.
In the Spotlight June 2009
Editors' Picks of Pharmaceutical Science & Technology Innovations
Report From: Ireland
Despite its shrinking domestic economy, Ireland is determined not to let its pharmaceutical industry fade into the shadow of global recession.
FDA Waves a Big Stick
Agency officials and manufacturers anticipate stricter enforcement of drug safety and quality.
Pharma Capsules
Brief pharmaceutical news items for June 2009.
Inside ICH: Quality Trio Takes Final Shape
FDA leaders explain the purpose and plan for ICH's three quality guidelines.
FDA Office of Generic Drugs Question-Based Review Initiative: An Update
The Question-Based Review (QbR) initiative of the Office of Generic Drugs has reached its second full year in 2009. Special from the Journal of Validation Technology.
Donning by Design: Sterile Cleanroom Gowning Evolves to Help Minimize Contamination Risk
A novel cleanroom apparel design incorporates modern concepts to help minimize contamination. Take a tour of the design.
