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Dr. Harish L. Rao ☆ India, 2007-10-12 11:32 (6832 d 17:11 ago) Posting: # 1178 Views: 8,064 |
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Dear Group Members, Why do we need to store plasma samples of bioequivalence studies below -70 degrees? Is the storage temperature stated in any of the guidelines? Besides the stability of the drug & deactivation of enzymes in plasma, is there any other specific reason for storage below -70 degrees? Which is the optimum temperature to be used for storage of plasma samples -60 or -70 or -80 degrees? Some CRO's are storing samples even at -20 degrees, based on literature survey. Is this acceptable from regulatory point of view? Thanks & regards, Dr. Harish L. Rao |
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Rajdeep ★ New Delhi, India, 2007-10-13 10:15 (6831 d 18:27 ago) @ Dr. Harish L. Rao Posting: # 1186 Views: 6,273 |
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Dear Sir Its not that whether we have a set of guidelines confirming the storage temperature. It has to be in accordance with the method development procedure and the conditions within which the drug does not disintegrate. Our CRO uses temperature anywhere between -16 °C to -60 °C depending on the feasibiliy. regards Rajdeep — Best regards Rajdeep Mukherjee Protocol Developer |
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Helmut ★★★   Vienna, Austria, 2007-10-13 17:40 (6831 d 11:02 ago) @ Dr. Harish L. Rao Posting: # 1188 Views: 6,300 |
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Dear Harish first I would agree with Rajdeep's post. Some interesting points are mentioned in Viswanathan CT, Bansal S, Booth B, DeStefano AJ, Rose MJ, Sailstad J, Shah VP, Skelly JP, Swann PG, and R Weiner Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays The AAPS Journal 2007; 9 (1) Article 4, E30-E42 online (see under heading: Separate Stability Experiments Required At -70°C if Stability Shown at -20°C) — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz