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Registerstability in guideline [Bioanalytics]
Dear experts.
I had longterm stability test in new drug.
Our result are -12% degradation in low concentration after 8 weeks, -16% degradation in high concentration after 8 weeks.
Is it fail in stability test? Normally, I think all stability data are within ±15% normally. However I can't find any special guideline in Bioanalytical method validation guidance.
Please give me your kind knowledge.
Thanks,
Best regards,
Kanon
I had longterm stability test in new drug.
Our result are -12% degradation in low concentration after 8 weeks, -16% degradation in high concentration after 8 weeks.
Is it fail in stability test? Normally, I think all stability data are within ±15% normally. However I can't find any special guideline in Bioanalytical method validation guidance.
Please give me your kind knowledge.
Thanks,
Best regards,
Kanon
Complete thread:
- stability in guidelinekanonpia 2009-09-07 10:30
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- stability in guideline yjlee168 2009-09-07 13:40
- stability in guideline kanonpia 2009-09-08 01:31
- stability in guideline yjlee168 2009-09-08 12:18
- stability in guideline kanonpia 2009-09-08 01:31
- stability in guideline yjlee168 2009-09-07 13:40
Ing. Helmut Schütz