Population pharmacokinetic and pharmacodynamic analysis of tesamorelin in HIV-infected patients and healthy subjects
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| 024 | 7 | 0 | |a 10.1007/s10928-015-9416-2 |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10928-015-9416-2 | ||
| 245 | 0 | 0 | |a Population pharmacokinetic and pharmacodynamic analysis of tesamorelin in HIV-infected patients and healthy subjects |h [Elektronische Daten] |c [Mario González-Sales, Olivier Barrière, Pierre Tremblay, Fahima Nekka, Jean-Claude Mamputu, Sylvie Boudreault, Mario Tanguay] |
| 520 | 3 | |a The objective of this analysis was to characterize the time course of selected pharmacodynamic (PD) markers of tesamorelin: growth hormone (GH) and insulin-like growth factor (IGF-1) concentrations in HIV-infected patients and healthy volunteers. A total of 41 subjects in Phase I trials receiving subcutaneous daily doses of 1 or 2mg of tesamorelin during 14 consecutive days were included in this analysis. A previous pharmacokinetic (PK) model of tesamorelin was used as the input function for the PD model of GH. Tesamorelin was hypothesized to stimulate the secretion of GH in an "episodic” manner, i.e., for a finite duration of time. The resulting PK/PD model of GH was used to describe the time course of IGF-1. The effect of age, body weight, body mass index, sex, race, and health status on the model parameters was evaluated. The model was qualified using predictive checks and non-parametric bootstrap. Within the range of the values evaluated no covariates were significantly associated with GH or IGF-1 model parameters. Model evaluation procedures indicated accurate prediction of the selected pharmacodynamic markers. The time course of GH and IGF-1 concentrations following multiple doses of tesamorelin were well predicted by the sequential PK/PD model developed using Phase I data. | |
| 540 | |a Springer Science+Business Media New York, 2015 | ||
| 690 | 7 | |a Phase I |2 nationallicence | |
| 690 | 7 | |a Clinical trial |2 nationallicence | |
| 690 | 7 | |a Population pharmacokinetics and pharmacodynamics |2 nationallicence | |
| 690 | 7 | |a Indirect response |2 nationallicence | |
| 690 | 7 | |a NONMEM |2 nationallicence | |
| 700 | 1 | |a González-Sales |D Mario |u Université de Montréal, Montreal, Canada |4 aut | |
| 700 | 1 | |a Barrière |D Olivier |u inVentiv Health Clinical, Montreal, Canada |4 aut | |
| 700 | 1 | |a Tremblay |D Pierre |u inVentiv Health Clinical, Montreal, Canada |4 aut | |
| 700 | 1 | |a Nekka |D Fahima |u Université de Montréal, Montreal, Canada |4 aut | |
| 700 | 1 | |a Mamputu |D Jean-Claude |u Theratechnologies Inc, Montreal, Canada |4 aut | |
| 700 | 1 | |a Boudreault |D Sylvie |u inVentiv Health Clinical, Montreal, Canada |4 aut | |
| 700 | 1 | |a Tanguay |D Mario |u inVentiv Health Clinical, Montreal, Canada |4 aut | |
| 773 | 0 | |t Journal of Pharmacokinetics and Pharmacodynamics |d Springer US; http://www.springer-ny.com |g 42/3(2015-06-01), 287-299 |x 1567-567X |q 42:3<287 |1 2015 |2 42 |o 10928 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10928-015-9416-2 |q text/html |z Onlinezugriff via DOI |
| 898 | |a BK010053 |b XK010053 |c XK010000 | ||
| 900 | 7 | |a Metadata rights reserved |b Springer special CC-BY-NC licence |2 nationallicence | |
| 908 | |D 1 |a research-article |2 jats | ||
| 949 | |B NATIONALLICENCE |F NATIONALLICENCE |b NL-springer | ||
| 950 | |B NATIONALLICENCE |P 856 |E 40 |u https://doi.org/10.1007/s10928-015-9416-2 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a González-Sales |D Mario |u Université de Montréal, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Barrière |D Olivier |u inVentiv Health Clinical, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Tremblay |D Pierre |u inVentiv Health Clinical, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Nekka |D Fahima |u Université de Montréal, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Mamputu |D Jean-Claude |u Theratechnologies Inc, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Boudreault |D Sylvie |u inVentiv Health Clinical, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Tanguay |D Mario |u inVentiv Health Clinical, Montreal, Canada |4 aut | ||
| 950 | |B NATIONALLICENCE |P 773 |E 0- |t Journal of Pharmacokinetics and Pharmacodynamics |d Springer US; http://www.springer-ny.com |g 42/3(2015-06-01), 287-299 |x 1567-567X |q 42:3<287 |1 2015 |2 42 |o 10928 | ||