Outsourcing Outlook
As demand for contract services slows down, contractors restructure themselves and the industry.
April 2003
Pharmaceutical science & technology news.
Identification of Out-of-Trend Stability Results
Representatives from PhRMA member companies discuss the growing concern about out-of-trend stability data, including possible statistical approaches and the implementation challenges to identifying OOT results.
The Relative Densisties of Pharmaceutical Powders, Blends, Dry Granulations, and Immediate-Release Tablets
The authors provide a combined source of density data and show that denity can be used as an equipment-independent sclaing parameter in the manufacture of common pharmaceutical solids.
Overhauling Compliance and GMPs
FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.
A Film Approach for the Stabilization of Gelatin Preparations Against Cross-Linking
A new approach for reducing pellicle formation involves the use of a combination of glycine and citric acid during the preparation of film mass or solution.
