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subramanian ● 2007-01-14 21:48 (7105 d 18:35 ago) Posting: # 467 Views: 7,673 |
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1. What is the procedure for the evaluation of administered hormones or peptides (human insulin)? 1a. Whether the correction using the basal levels (Subtraction of the amount present at predose) is more acceptable when compared to the correction using placebo at different time intervals. The answers will through light on the growing demands of endogenous compounds estimation |
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drshiv ★ India, 2007-02-28 19:34 (7060 d 20:48 ago) @ subramanian Posting: # 547 Views: 6,076 |
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Dear Subramanian, Assuming that you are asking for human insulin, the type of study required is not regular BE study, instead conducting glucose clamp studies are more appropriate. Clamp studies are well accepted and standardized for comparing insulin like products. For your second question on endogenous hormones, base line correction method is good. Take approximately three pre-dose smaples and take average and subtract beofre PK analysis. Regards, Dr. Shiv -- Edit: Full quote removed. [HS] |
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sudeshnamandal1 ☆ India, 2008-03-05 09:52 (6690 d 06:31 ago) @ drshiv Posting: # 1660 Views: 5,896 |
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If the analyte is endogeneous nature (e.g. ursodiol), how will go for selectivity experiment during method validation, as the interference will come more than 20 % of the mean Analyte(s) area response of LLOQ (at analyte retention time). -- Edit: Full quote removed. Please see this post! [HS] — Sudeshna |
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Helmut ★★★   Vienna, Austria, 2008-03-05 14:25 (6690 d 01:58 ago) @ sudeshnamandal1 Posting: # 1661 Views: 6,120 |
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Dear Sudeshna, you may opt for charcoal stripped plasma/serum - but only for 'classical' chemical methods (according to the Arlington III white-paper stripped matrix is not acceptable for Ligand-Binding Assays). Sources: Monobind (Lake Forest, CA, USA) Scantibodies Laboratory (Santee, CA, USA) BioChemed Services (Winchester, VA, USA) — 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 |
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laxmankaswan ● 2008-03-17 13:29 (6678 d 02:54 ago) @ sudeshnamandal1 Posting: # 1700 Views: 5,739 |
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Hi In this case u can take the average of predose samples and substract that area from LLOQ sample or you can compare with avearge area of blank samples with your LLOQ and compare the gain in percent area. regards laxman |
Ing. Helmut Schütz