Pharmaceutical Technology-04-02-2003

Pharmaceutical Technology

Outsourcing Outlook

April 02, 2003

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

April 2003

April 02, 2003

In the Field

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Pharmaceutical science & technology news.

Identification of Out-of-Trend Stability Results

April 02, 2003

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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

April 02, 2003

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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

April 02, 2003

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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

April 02, 2003

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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.