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Reporting guidelines for population pharmacokinetic analyses
The purpose of this work was to develop a consolidated set of guiding principles for reporting of population pharmacokinetic (PK) analyses based on input from a survey of practitioners as well as discussions between industry, consulting and regulatory scientists. The survey found that identification...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer US
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4432104/ https://www.ncbi.nlm.nih.gov/pubmed/25925797 http://dx.doi.org/10.1007/s10928-015-9417-1 |
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author | Dykstra, Kevin Mehrotra, Nitin Tornøe, Christoffer Wenzel Kastrissios, Helen Patel, Bela Al-Huniti, Nidal Jadhav, Pravin Wang, Yaning Byon, Wonkyung |
author_facet | Dykstra, Kevin Mehrotra, Nitin Tornøe, Christoffer Wenzel Kastrissios, Helen Patel, Bela Al-Huniti, Nidal Jadhav, Pravin Wang, Yaning Byon, Wonkyung |
author_sort | Dykstra, Kevin |
collection | PubMed |
description | The purpose of this work was to develop a consolidated set of guiding principles for reporting of population pharmacokinetic (PK) analyses based on input from a survey of practitioners as well as discussions between industry, consulting and regulatory scientists. The survey found that identification of population covariate effects on drug exposure and support for dose selection (where population PK frequently serves as preparatory analysis to exposure–response modeling) are the main areas of influence for population PK analysis. The proposed guidelines consider two main purposes of population PK reports (1) to present key analysis findings and their impact on drug development decisions, and (2) as documentation of the analysis methods for the dual purpose of enabling review of the analysis and facilitating future use of the models. This work also identified two main audiences for the reports: (1) a technically competent group responsible for in-depth review of the data, methodology, and results, and (2) a scientifically literate, but not technically adept group, whose main interest is in the implications of the analysis for the broader drug development program. We recommend a generalized question-based approach with six questions that need to be addressed throughout the report. We recommend eight sections (Synopsis, Introduction, Data, Methods, Results, Discussion, Conclusions, Appendix) with suggestions for the target audience and level of detail for each section. A section providing general expectations regarding population PK reporting from a regulatory perspective is also included. We consider this an important step towards industrialization of the field of pharmacometrics such that non-technical audience also understands the role of pharmacometrics analyses in decision making. Population PK reports were chosen as representative reports to derive these recommendations; however, the guiding principles presented here are applicable for all pharmacometric reports including PKPD and simulation reports. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10928-015-9417-1) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4432104 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-44321042015-05-19 Reporting guidelines for population pharmacokinetic analyses Dykstra, Kevin Mehrotra, Nitin Tornøe, Christoffer Wenzel Kastrissios, Helen Patel, Bela Al-Huniti, Nidal Jadhav, Pravin Wang, Yaning Byon, Wonkyung J Pharmacokinet Pharmacodyn Original Paper The purpose of this work was to develop a consolidated set of guiding principles for reporting of population pharmacokinetic (PK) analyses based on input from a survey of practitioners as well as discussions between industry, consulting and regulatory scientists. The survey found that identification of population covariate effects on drug exposure and support for dose selection (where population PK frequently serves as preparatory analysis to exposure–response modeling) are the main areas of influence for population PK analysis. The proposed guidelines consider two main purposes of population PK reports (1) to present key analysis findings and their impact on drug development decisions, and (2) as documentation of the analysis methods for the dual purpose of enabling review of the analysis and facilitating future use of the models. This work also identified two main audiences for the reports: (1) a technically competent group responsible for in-depth review of the data, methodology, and results, and (2) a scientifically literate, but not technically adept group, whose main interest is in the implications of the analysis for the broader drug development program. We recommend a generalized question-based approach with six questions that need to be addressed throughout the report. We recommend eight sections (Synopsis, Introduction, Data, Methods, Results, Discussion, Conclusions, Appendix) with suggestions for the target audience and level of detail for each section. A section providing general expectations regarding population PK reporting from a regulatory perspective is also included. We consider this an important step towards industrialization of the field of pharmacometrics such that non-technical audience also understands the role of pharmacometrics analyses in decision making. Population PK reports were chosen as representative reports to derive these recommendations; however, the guiding principles presented here are applicable for all pharmacometric reports including PKPD and simulation reports. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s10928-015-9417-1) contains supplementary material, which is available to authorized users. Springer US 2015-04-30 2015 /pmc/articles/PMC4432104/ /pubmed/25925797 http://dx.doi.org/10.1007/s10928-015-9417-1 Text en © The Author(s) 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Paper Dykstra, Kevin Mehrotra, Nitin Tornøe, Christoffer Wenzel Kastrissios, Helen Patel, Bela Al-Huniti, Nidal Jadhav, Pravin Wang, Yaning Byon, Wonkyung Reporting guidelines for population pharmacokinetic analyses |
title | Reporting guidelines for population pharmacokinetic analyses |
title_full | Reporting guidelines for population pharmacokinetic analyses |
title_fullStr | Reporting guidelines for population pharmacokinetic analyses |
title_full_unstemmed | Reporting guidelines for population pharmacokinetic analyses |
title_short | Reporting guidelines for population pharmacokinetic analyses |
title_sort | reporting guidelines for population pharmacokinetic analyses |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4432104/ https://www.ncbi.nlm.nih.gov/pubmed/25925797 http://dx.doi.org/10.1007/s10928-015-9417-1 |
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