Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance

This tutorial describes the development of a population pharmacokinetic (Pop PK) analysis guidance within Pfizer, which strives for improved consistency and efficiency, and a more systematic approach to model building. General recommendations from the Pfizer internal guidance and a suggested workflo...

Descripción completa

Detalles Bibliográficos
Autores principales: Byon, W, Smith, MK, Chan, P, Tortorici, MA, Riley, S, Dai, H, Dong, J, Ruiz‐Garcia, A, Sweeney, K, Cronenberger, C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2013
Materias:
Tutorial
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6483270/
https://www.ncbi.nlm.nih.gov/pubmed/23836283
http://dx.doi.org/10.1038/psp.2013.26
_version_ 1783414004524253184
author Byon, W
Smith, MK
Chan, P
Tortorici, MA
Riley, S
Dai, H
Dong, J
Ruiz‐Garcia, A
Sweeney, K
Cronenberger, C
author_facet Byon, W
Smith, MK
Chan, P
Tortorici, MA
Riley, S
Dai, H
Dong, J
Ruiz‐Garcia, A
Sweeney, K
Cronenberger, C
author_sort Byon, W
collection PubMed
description This tutorial describes the development of a population pharmacokinetic (Pop PK) analysis guidance within Pfizer, which strives for improved consistency and efficiency, and a more systematic approach to model building. General recommendations from the Pfizer internal guidance and a suggested workflow for Pop PK model building are discussed. A description is also provided for mechanisms by which conflicting opinions were captured and resolved across the organization to arrive at the final guidance. CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e51; doi:10.1038/psp.2013.26; advance online publication 3 July 2013
format Online
Article
Text
id pubmed-6483270
institution National Center for Biotechnology Information
language English
publishDate 2013
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-64832702019-05-02 Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance Byon, W Smith, MK Chan, P Tortorici, MA Riley, S Dai, H Dong, J Ruiz‐Garcia, A Sweeney, K Cronenberger, C CPT Pharmacometrics Syst Pharmacol Tutorial This tutorial describes the development of a population pharmacokinetic (Pop PK) analysis guidance within Pfizer, which strives for improved consistency and efficiency, and a more systematic approach to model building. General recommendations from the Pfizer internal guidance and a suggested workflow for Pop PK model building are discussed. A description is also provided for mechanisms by which conflicting opinions were captured and resolved across the organization to arrive at the final guidance. CPT: Pharmacometrics & Systems Pharmacology (2013) 2, e51; doi:10.1038/psp.2013.26; advance online publication 3 July 2013 John Wiley and Sons Inc. 2013-07-03 2013-07 /pmc/articles/PMC6483270/ /pubmed/23836283 http://dx.doi.org/10.1038/psp.2013.26 Text en © 2013 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/3.0/ Licence, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Tutorial
Byon, W
Smith, MK
Chan, P
Tortorici, MA
Riley, S
Dai, H
Dong, J
Ruiz‐Garcia, A
Sweeney, K
Cronenberger, C
Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title_full Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title_fullStr Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title_full_unstemmed Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title_short Establishing Best Practices and Guidance in Population Modeling: An Experience With an Internal Population Pharmacokinetic Analysis Guidance
title_sort establishing best practices and guidance in population modeling: an experience with an internal population pharmacokinetic analysis guidance
topic Tutorial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6483270/
https://www.ncbi.nlm.nih.gov/pubmed/23836283
http://dx.doi.org/10.1038/psp.2013.26
work_keys_str_mv AT byonw establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT smithmk establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT chanp establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT tortoricima establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT rileys establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT daih establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT dongj establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT ruizgarciaa establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT sweeneyk establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance
AT cronenbergerc establishingbestpracticesandguidanceinpopulationmodelinganexperiencewithaninternalpopulationpharmacokineticanalysisguidance

Ejemplares similares