Pharmaceutical Technology Europe-05-01-2004

Pharmaceutical Technology Europe

21 CFR Part 11 and Risk Assessment: Adapting Fundamental Methodologies to a Current Rule

May 01, 2004

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FDA expects a firm that is subject to GxP to develop a risk evaluation of its product and to then mitigate the identified risks. Identified risks may be addressed by technical fixes that effectively eliminate the risks or reduce the likelihood of occurrence and/or severity of consequences to acceptable levels.

Depressing Stories about Pharmaceutical Control

May 01, 2004

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What Medawar is calling for is "an overhaul of the secretive and profoundly inadequate system of medicines control," and hopes the unfolding crisis of dependency on antidepressants will prove to be a watershed.

Use of Artificial Neural Networks and Genetic Algorithms - Experiences from a Tablet Formulation

May 01, 2004

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This article describes the formulation of a tablet for a specific purpose, primarily using fractional or full factorial designs. The formulation work generated a matrix that was processed by two software packages based on neural networks. When the dataset was divided into smaller subsets, the agreement between the predicted and observed tablet properties of the optimized formulations was reasonable.

Studies of PLGA Microspheres

May 01, 2004

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In this article, the authors describe a study into the factorial effect of selected process parameters on the pharmaceutical characteristics of poly(DL-lactide-co-glycolide) microspheres containing methotrexate. A study of the microspheres' stability at refrigerated temperatures is also examined.

Using High Temperature HPLC for Improved Analysis

May 01, 2004

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Operating HPLC at higher than ambient temperatures can improve peak shapes and enable faster run times. Preheating the mobile phase is significant in high temperature liquid chromatography as the relationship between temperature and viscosity strongly influences the mobile phase flow profile and the diffusion characteristics. With temperature programming, thermal gradients mimic solvent gradients because of the changing polarity of the mobile phase and interactions with the stationary phase; often thermal gradients can replace solvent gradients.