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Article: Generics, pioneers not happy with OGD's guidance.(Office of Generic Drugs)(Brief Article)
- Article from:
- Validation Times
- Article date:
- November 1, 1999
- Author:
CopyrightCOPYRIGHT 1999 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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BETHESDA, MD -- FDA's draft blend uniformity analysis guidance does not allow for sampling error, and that is a major error, Chris Pelloni of Teva Pharma-ceuticals, charged at last month's technical workshop of the generic trade associations.
Designed to help generic firms deal with out-of-specifica-tion (OOS) results issues, Pelloni took issue with the document's idea for acceptance criteria, which provides for a mean value of 90% - 110%, with a relative standard deviation of less than 5%. He claimed that it does not allow for sampling error.
He also said FDA is applying the guidance, despite the fact it is still a "draft" document.
"This has ...