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PRZOOM - /newswire/ -
Muenster, North Rhine-Westfalia, Germany, 2008/09/26 - International experts discussed how to realise more efficient stability tests for medicinal products last Thursday and Friday (18 and 19 September) in London.
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International experts discussed how to realise more efficient stability tests for medicinal products last Thursday and Friday (18 and 19 September) in London. At the two-day "Optimising Stability Testing" conference Dr Sven Oliver Kruse, managing director of Diapharm Analytics GmbH, was one of those explaining how the burden of ongoing stability tests can be reduced with improved study design. All medicinal products on the market must be monitored in a continuous programme in order to demonstrate stability and quality over their entire market life.
"Laboratory analysis is a cost factor that still offers room for manoeuvre in many companies" reported Dr Sven Oliver Kruse. The flexibility in the EU GMP guideline on "Ongoing stability" in particular offers opportunities for improved efficiency. For example, for generally identical medicinal products with a similar primary packaging but different strengths the guideline permits group building within the concept of "bracketing". If justified, it is also permitted to reduce the frequency of tests recognised as noncritical. "However, it is important to know possible pitfalls and to make an individual risk-benefit assessment for each product," Dr. Kruse emphasised.
At the "Optimising Stability Testing" conference a total of 14 speakers described a variety of options for optimising stability testing – from the form of the study design, through analytical and statistical evaluation procedures, data and report management systems up to outsourcing. Pharmaceutical industry chief executives and senior staff from Europe, North America and Africa, from company laboratories and from service providers attended the conference in London initiated by Visiongain.
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