biocomparison study
Russian translation: исследование по сравнению биодоступности
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| 18:48 Aug 29, 2008 |
| English to Russian translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Stanislav Korobov Ukraine Local time: 19:06 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 5 +2 | исследование по сравнению биодоступности |
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| 4 +1 | Сравнительное фармакокинетическое исследование |
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Answers
15 mins confidence: 
peer agreement (net): +2
peer agreement (net): +2исследование по сравнению биодоступности Explanation: -------------------------------------------------- Note added at 17 mins (2008-08-29 19:06:11 GMT) -------------------------------------------------- Вот еще один пример, из которого ясно, что в исследованиях данного типа производится сравнение биодоступности различных лекарственных форм. http://abstracts.aapspharmaceutica.com/ExpoAAPS07/CC/forms/a... Changes in formulation composition and/or dosage form (eg. capsules vs. tablets) have been reported to potentially alter drug bioavailability. In this study we conducted a retrospective analysis to evaluate the utility of absorption simulations in predicting biopharmaceutical performance using data from a Phase I biocomparison study which evaluated three formulations of a BCS Class II weak acid drug development candidate. In vitro dissolution profiles were assessed using USP II apparatus. The GastroPlusTM (Simulations Plus, Inc.) software suite was used to build an absorption model and predict relative performance of the formulations following oral administration to humans at the clinically relevant dose. The in vivo plasma concentration plasma profiles were simulated using solubility vs. pH profiles as well experimental dissolution data as input for the simulations. A virtual trial using the GastroPlusTM module with 12 subjects was also conducted to assess potential outcome of a clinical biocomparison study between the three formulations. Variability (log-normal variable distribution assumed) in both intestinal transit time (CV 20%), patient weight and pharmacokinetic parameters (CV 20-60% based on clinical data) was incorporated in the simulations. |
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Notes to answerer
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7 hrs confidence:  peer agreement (net): +1
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