Modeling of Large Pharmacokinetic Data Using Nonlinear Mixed‐Effects: A Paradigm Shift in Veterinary Pharmacology. A Case Study With Robenacoxib in Cats
The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed‐effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsel...
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| Published in: | CPT: pharmacometrics and systems pharmacology Vol. 5; no. 11; pp. 625 - 635 |
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01-11-2016
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| Abstract | The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed‐effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsely sampled preoperatively. Data from both routes were modeled sequentially using Monolix 4.3.2. Influence of parameter correlations and available covariates (age, gender, bodyweight, and anesthesia) on population parameter estimates were evaluated by using multiple samples from the posterior distribution of the random effects. A bicompartmental disposition model with simultaneous zero and first‐order absorption best described robenacoxib PKs in blood. Clearance was 0.502 L/kg/h and the bioavailability was high (78%). The absorption constant point estimate (Ka = 0.68 h−1) was lower than beta (median, 1.08 h−1), unveiling flip‐flop kinetics. No dosing adjustment based on available covariates information is advocated. This modeling work constitutes the first application of NLME in a large feline population. |
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| AbstractList | The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed-effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsely sampled preoperatively. Data from both routes were modeled sequentially using Monolix 4.3.2. Influence of parameter correlations and available covariates (age, gender, bodyweight, and anesthesia) on population parameter estimates were evaluated by using multiple samples from the posterior distribution of the random effects. A bicompartmental disposition model with simultaneous zero and first-order absorption best described robenacoxib PKs in blood. Clearance was 0.502 L/kg/h and the bioavailability was high (78%). The absorption constant point estimate (K
= 0.68 h
) was lower than beta (median, 1.08 h
), unveiling flip-flop kinetics. No dosing adjustment based on available covariates information is advocated. This modeling work constitutes the first application of NLME in a large feline population. The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed‐effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsely sampled preoperatively. Data from both routes were modeled sequentially using Monolix 4.3.2. Influence of parameter correlations and available covariates (age, gender, bodyweight, and anesthesia) on population parameter estimates were evaluated by using multiple samples from the posterior distribution of the random effects. A bicompartmental disposition model with simultaneous zero and first‐order absorption best described robenacoxib PKs in blood. Clearance was 0.502 L/kg/h and the bioavailability was high (78%). The absorption constant point estimate (K a = 0.68 h −1 ) was lower than beta (median, 1.08 h −1 ), unveiling flip‐flop kinetics. No dosing adjustment based on available covariates information is advocated. This modeling work constitutes the first application of NLME in a large feline population. The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed‐effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsely sampled preoperatively. Data from both routes were modeled sequentially using Monolix 4.3.2. Influence of parameter correlations and available covariates (age, gender, bodyweight, and anesthesia) on population parameter estimates were evaluated by using multiple samples from the posterior distribution of the random effects. A bicompartmental disposition model with simultaneous zero and first‐order absorption best described robenacoxib PKs in blood. Clearance was 0.502 L/kg/h and the bioavailability was high (78%). The absorption constant point estimate (Ka = 0.68 h−1) was lower than beta (median, 1.08 h−1), unveiling flip‐flop kinetics. No dosing adjustment based on available covariates information is advocated. This modeling work constitutes the first application of NLME in a large feline population. The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed-effects (NLME) approach, leveraging all available information collected from cats receiving robenacoxib s.c. and/or i.v.: 47 densely sampled laboratory cats and 36 clinical cats sparsely sampled preoperatively. Data from both routes were modeled sequentially using Monolix 4.3.2. Influence of parameter correlations and available covariates (age, gender, bodyweight, and anesthesia) on population parameter estimates were evaluated by using multiple samples from the posterior distribution of the random effects. A bicompartmental disposition model with simultaneous zero and first-order absorption best described robenacoxib PKs in blood. Clearance was 0.502 L/kg/h and the bioavailability was high (78%). The absorption constant point estimate (Ka = 0.68 h-1 ) was lower than beta (median, 1.08 h-1 ), unveiling flip-flop kinetics. No dosing adjustment based on available covariates information is advocated. This modeling work constitutes the first application of NLME in a large feline population. |
| Author | Soubret, A Elliott, J King, JN Pelligand, L Mochel, JP |
| AuthorAffiliation | 3 Elanco Animal Health Inc. Basel Switzerland 1 Royal Veterinary College Hatfield United Kingdom 2 Department of Pharmacometrics Novartis Pharmaceuticals Basel Switzerland |
| AuthorAffiliation_xml | – name: 3 Elanco Animal Health Inc. Basel Switzerland – name: 2 Department of Pharmacometrics Novartis Pharmaceuticals Basel Switzerland – name: 1 Royal Veterinary College Hatfield United Kingdom |
| Author_xml | – sequence: 1 givenname: L surname: Pelligand fullname: Pelligand, L email: lpelligand@rvc.ac.uk organization: Royal Veterinary College – sequence: 2 givenname: A surname: Soubret fullname: Soubret, A organization: Novartis Pharmaceuticals – sequence: 3 givenname: JN surname: King fullname: King, JN organization: Elanco Animal Health Inc – sequence: 4 givenname: J surname: Elliott fullname: Elliott, J organization: Royal Veterinary College – sequence: 5 givenname: JP surname: Mochel fullname: Mochel, JP organization: Novartis Pharmaceuticals |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27770596$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1111/jvp.12060 10.2460/ajvr.2005.66.1162 10.3109/03602538409015063 10.1002/jps.2600711209 10.1201/b17203 10.1111/j.1532-950X.1998.tb00533.x 10.1111/j.1365-2885.2008.01016.x 10.2460/ajvr.74.3.465 10.1111/j.1365-2885.2004.00605.x 10.1111/j.1365-2885.2004.00617.x 10.1111/j.1365-2885.2009.01134.x 10.1007/s11095-014-1587-9 10.1111/j.1365-2885.2011.01288.x 10.1007/s11095-010-0262-z 10.1023/A:1012299115260 10.1016/j.rvsc.2013.04.021 10.1208/ps040438 10.1111/jvp.12107 10.1067/mcp.2002.121829 10.1208/s12248-012-9407-9 10.1146/annurev.pa.32.040192.001153 10.1007/s11095-016-2020-3 10.1208/s12248-009-9133-0 10.1046/j.1365-2885.2001.00346.x 10.1111/j.1365-2885.2004.00600.x 10.1111/j.1365-2885.2007.00826.x 10.1111/j.1365-2885.2008.01035.x |
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| Copyright | 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics 2016 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. 2016. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. |
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| Snippet | The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed‐effects (NLME) approach, leveraging all... The objective of this study was to model the pharmacokinetics (PKs) of robenacoxib in cats using a nonlinear mixed-effects (NLME) approach, leveraging all... |
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| SubjectTerms | Administration, Intravenous Animals Area Under Curve Biological Availability Cats Datasets Design Diphenylamine - administration & dosage Diphenylamine - analogs & derivatives Diphenylamine - pharmacokinetics Drug dosages Female Injections, Subcutaneous Laboratory animals Metabolic Clearance Rate Nonlinear Dynamics Original Pharmacokinetics Phenylacetates - administration & dosage Phenylacetates - pharmacokinetics R&D Random Allocation Research & development Studies Veterinary medicine |
| Title | Modeling of Large Pharmacokinetic Data Using Nonlinear Mixed‐Effects: A Paradigm Shift in Veterinary Pharmacology. A Case Study With Robenacoxib in Cats |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fpsp4.12141 https://www.ncbi.nlm.nih.gov/pubmed/27770596 https://www.proquest.com/docview/2290759500 https://search.proquest.com/docview/1835521177 https://pubmed.ncbi.nlm.nih.gov/PMC5193001 |
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