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kanonpia ☆ Korea, 2009-09-07 12:30 (6135 d 21:59 ago) (edited on 2009-09-07 12:59) Posting: # 4156 Views: 3,410 |
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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 |
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yjlee168 ★★★   Kaohsiung, Taiwan, 2009-09-07 15:40 (6135 d 18:50 ago) (edited on 2009-09-07 17:25) @ kanonpia Posting: # 4157 Views: 2,734 |
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Dear 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. Wow! There seems significant change at accelerated condition within 3 months occurred. ❝ 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. It won't be failed IF the shelf life of this new drug is claimed to be like 4 weeks or less since it is manufactured. But it sounds like unrealistic. Here is the Bioanalytical Method Validation from US FDA.  And if you need the Q1E Evaluation of Stability Data, it's here. — All the best, -- Yung-jin Lee bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
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kanonpia ☆ Korea, 2009-09-08 03:31 (6135 d 06:58 ago) @ yjlee168 Posting: # 4163 Views: 2,648 |
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❝ It won't be failed IF the shelf life of this new drug is claimed to be like 4 ❝ weeks or less since it is manufactured. But it sounds like unrealistic. -> manufactured stability was very good. this data is stability in analytical method. Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post and the Forum's Policy! [Helmut] |
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yjlee168 ★★★ Kaohsiung, Taiwan, 2009-09-08 14:18 (6134 d 20:11 ago) @ kanonpia Posting: # 4168 Views: 2,624 |
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Dear kanonpia, Sorry about my misunderstanding. I've got your points now. ❝ -> manufactured stability was very good. this data is stability in ❝ analytical method. — All the best, -- Yung-jin Lee bear v2.9.6:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
Ing. Helmut Schütz