Congress Adopts New User Fee Program
To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.
Validation Basics: A System Developer's Approach to Validation
Following a step-by-step approach to software development involves planning, analysis, construction, and implementation.
Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications
The rapid and accurate determination of headspace oxygen in various pharmaceutical packaging forms poses unique analytical challenges.
How to Engage in a Strategic Outsourcing Relationship
Carefully crafted outsourcing arrangements allow companies to become powerful partners in the quest for market share.
Particle-Size Distribution II: The Problem of Sampling Powdered Solids
Dynamic powder-sampling methods may be the best techniques for obtaining a representative sample for determining particle-size distribution.
Novel Approaches for Topical Delivery of Acetazolamide
Extensive research has been conducted to improve the solubility and permeability of acetazolamide in hopes that a topical formulation for the treatment of glaucoma can be developed.
Outsourcing Outlook
The author discusses the Japanese cabinet's approval of a measure that lifts manufacturing restrictions on domestic pharmaceutical companies.
Electrodeionization in Pharmaceutical Water Treatment
Electrodeionization units can reduce or eliminate the cost and hazards associated with traditional technologies for producing water intended for use in final drug dosage forms.
