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manojskr ☆ India, 2014-02-20 16:07 (4112 d 12:24 ago) Posting: # 12462 Views: 6,537 |
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Dear All, I need to do a bioequivalence study (for EMEA region) for thiocolchicoside in human plasma. Some paper suggests that it is impractical to analyze thiocolchicoside in human plasma as it rapidly converts to its active metabolite 3-desmethylthiocolchicine. Hence, analysis of 3-desmethylthiocolchicine is better for BE evaluation. However, some papers also refer analysis of thiocolchicoside for BE evaluation. Now it is confusing whether thiocolchicoside can realy be detected in human plasma for evaluation of BE or not? Kindly suggest Regards, Manoj K Singh Edit: Please follow the Forum’s Policy. I deleted another post with identical wording. [Helmut] |
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mittyri ★★ Russia, 2014-02-20 18:51 (4112 d 09:41 ago) @ manojskr Posting: # 12463 Views: 5,286 |
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Dear Manoj, So sorry to disturb you but where did you find the papers about the analysis of TLC in human plasma for BE evaluation? "...we confirmed Sutherland et al. finding that the drug is not detectable in the plasma of healthy human subjects after oral administration." from M. Trellu et al. — Kind regards, Mittyri |
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jag009 ★★★ NJ, 2014-02-20 22:29 (4112 d 06:02 ago) @ mittyri Posting: # 12466 Views: 5,308 |
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Hi, ❝ So sorry to disturb you but where did you find the papers about the analysis of TLC in human plasma for BE evaluation? This one I guess... P KUMARA,S SHUKLAB, et al. BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF THIOCOLCHICOSIDE AND LORNOXICAM IN HUMAN PLASMA AND IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC Free article John |
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mittyri ★★ Russia, 2014-02-21 07:39 (4111 d 20:52 ago) @ jag009 Posting: # 12469 Views: 5,282 |
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Hi John, I think no chance after oral administration: "Limit of quantification (LOQ): ...The LOQ was found to be 100.82 ng/mL <...>for THC" from P KUMARA,S SHUKLAB, et al. "Moreover, using a liquid chromatography-MS-MS method, Sutherland et al. found only traces of the parent drug in plasma of healthy volunteers given 8 mg orally (the recommended therapeutic dose). In that study, concentrations were all below 0.30 ng/mL, the lower limit of quantification (LLOQ), apart from the first sampling point, where it was approximately equal to the LLOQ<...> Again, TCC was below the limit of quantification (<1 ng/mL) and only the pharmacologically active metabolite M1 was detected." from M. Trellu et al. (Emphasis by me) By the way they recommended to perform PK studies of TCC with a bioanalytical method that can specifically assay both TCC and its metabolite. So everyone can try and look for parent drug  — Kind regards, Mittyri |
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manojskr ☆ India, 2014-02-21 15:37 (4111 d 12:54 ago) @ mittyri Posting: # 12470 Views: 5,201 |
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Dear Mittyri, Thanks to you and Mr. John for your response. This is also referred from ANVISA Lista 2 to analyze "Tiocolchicosideo" for BE studies. Regards, Manoj Singh |
Ing. Helmut Schütz