Still Waiting for Answers
Amid the finger-pointing, hand-wringing, and bloviating, the supply of hard, technical information remains frustratingly small.
Method Validation by Phase of Development: An Acceptable Analytical Practice
This article provides guidance for minimally acceptable method validation practices and a foundation for assessing the risks and benefits associated with method validation programs.
Comparing and Contrasting Barrier Isolator Decontamination Systems
A discussion of the validation and operation of two commercially available vapor-phase hydrogen peroxide decontamination systems is presented, based on a hands-on examination of both systems.
November 2004
Pharmaceutical Science & Technology News
In the Spotlight-November 2004
Pharmaceutical Science & Technology Innovations
Searching for a Viable Business Model
What should pharmaceutical companies make of recent corporate developments at several high-profile service providers?
Bringing Formulations to Size: Strategies for Micro- and Nanoparticle Development
With creative engineering and sophisticated chemistry, industry scientists offer big solutions for attaining small particle sizes and narrow distributions.
FDA Moves To Implement New GMP Policies
Phase II of FDA's GMP modernization plan may involve revising regulations to fit new policies and inspection and review programs.
