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avinash ★ India, 2014-07-03 08:49 (3979 d 15:27 ago) Posting: # 13207 Views: 4,171 |
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Dear Members, We have to perform “Thyroid hormone” assay for BA/BE studies, using “Electrochemiluminescence” method. The method was fully validated by manufacturer. In this method the calibration curve is generated using the Master calibration curve provided by the kit, hence there is no spiking of calibration standards and quality controls. Please suggest what would be the additional validation parameters that need to be performed to support the FDA method validation requirement? Thanks & regards, Avinash Jain |
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Ohlbe ★★★ France, 2014-07-03 14:08 (3979 d 10:08 ago) @ avinash Posting: # 13210 Views: 3,396 |
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Dear Avinash, ❝ The method was fully validated by manufacturer. For patient follow-up, not for BE trials... ❝ Please suggest what would be the additional validation parameters that need to be performed to support the FDA method validation requirement? Do your homework: read the draft FDA guidance on bioanalytical method validation, section C, particularly lines 853 to 883. This is just a draft, but I think it provides a good "suggestion". — Regards Ohlbe |
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avinash ★ India, 2014-07-04 13:43 (3978 d 10:32 ago) @ Ohlbe Posting: # 13215 Views: 3,283 |
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Dear Ohlbe, Thanks for the response. For qualitative clinical diagnostic assay like Electrochemiluminescence do not fully comply with the USFDA guidance, full calibration curve cannot be generated with each run, as Master calibration curve provided by the kit. In case if we prove the appropriateness of calibration by using QC at different concentrations spanning entire range of study sample concentration. Can this method be used for bioequivalence study? Thanks & regards, Avinash |
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