Released on: September 26, 2008, 6:31 am

Press Release Author: Diapharm

Industry: Pharmaceuticals

Press Release Summary: 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 (www.diapharm.com),
was one of those explaining how the burden of ongoing stability tests can be reduced
with improved study design.

Press Release Body: Münster, 26 September 2008. 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 (www.diapharm.com), 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.


Web Site: http://www.diapharm.com

Contact Details: Christian Rieke
Zumsandestr.32
48145 Muenster
Germany
wort@co-operate.net