Pharmaceutical Technology-04-02-2003

As demand for contract services slows down, contractors restructure themselves and the industry.

Pharmaceutical science & technology news.

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 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.

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 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.