Reporting guidelines for population pharmacokinetic analyses
| LEADER | caa a22 4500 | ||
|---|---|---|---|
| 001 | 605533903 | ||
| 003 | CHVBK | ||
| 005 | 20210128100840.0 | ||
| 007 | cr unu---uuuuu | ||
| 008 | 210128e20150601xx s 000 0 eng | ||
| 024 | 7 | 0 | |a 10.1007/s10928-015-9417-1 |2 doi |
| 035 | |a (NATIONALLICENCE)springer-10.1007/s10928-015-9417-1 | ||
| 245 | 0 | 0 | |a Reporting guidelines for population pharmacokinetic analyses |h [Elektronische Daten] |c [Kevin Dykstra, Nitin Mehrotra, Christoffer Tornøe, Helen Kastrissios, Bela Patel, Nidal Al-Huniti, Pravin Jadhav, Yaning Wang, Wonkyung Byon] |
| 520 | 3 | |a 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. | |
| 540 | |a The Author(s), 2015 | ||
| 690 | 7 | |a Pharmacometrics |2 nationallicence | |
| 690 | 7 | |a Population pharmacokinetics |2 nationallicence | |
| 690 | 7 | |a PK reporting |2 nationallicence | |
| 690 | 7 | |a Regulatory submission |2 nationallicence | |
| 690 | 7 | |a Best practices |2 nationallicence | |
| 700 | 1 | |a Dykstra |D Kevin |u qPharmetra LLC, Andover, MA, USA |4 aut | |
| 700 | 1 | |a Mehrotra |D Nitin |u Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | |
| 700 | 1 | |a Tornøe |D Christoffer |u Clinical Reporting, Novo Nordisk, Copenhagen, Denmark |4 aut | |
| 700 | 1 | |a Kastrissios |D Helen |u Pharsight Consulting Services, Certara, St. Louis, MO, USA |4 aut | |
| 700 | 1 | |a Patel |D Bela |u Clinical Pharmacology, Quantitative Sciences, GlaxoSmithKline, King of Prussia, PA, USA |4 aut | |
| 700 | 1 | |a Al-Huniti |D Nidal |u Quantitative Clinical Pharmacology, AstraZeneca, Waltham, MA, USA |4 aut | |
| 700 | 1 | |a Jadhav |D Pravin |u Quantitative Pharmacology and Pharmacometrics, Merck and Co., Whitehouse Station, NJ, USA |4 aut | |
| 700 | 1 | |a Wang |D Yaning |u Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | |
| 700 | 1 | |a Byon |D Wonkyung |u Global Innovative Pharma Business Clinical Pharmacology, Pfizer Inc., Groton, CT, USA |4 aut | |
| 773 | 0 | |t Journal of Pharmacokinetics and Pharmacodynamics |d Springer US; http://www.springer-ny.com |g 42/3(2015-06-01), 301-314 |x 1567-567X |q 42:3<301 |1 2015 |2 42 |o 10928 | |
| 856 | 4 | 0 | |u https://doi.org/10.1007/s10928-015-9417-1 |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/s10928-015-9417-1 |q text/html |z Onlinezugriff via DOI | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Dykstra |D Kevin |u qPharmetra LLC, Andover, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Mehrotra |D Nitin |u Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Tornøe |D Christoffer |u Clinical Reporting, Novo Nordisk, Copenhagen, Denmark |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Kastrissios |D Helen |u Pharsight Consulting Services, Certara, St. Louis, MO, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Patel |D Bela |u Clinical Pharmacology, Quantitative Sciences, GlaxoSmithKline, King of Prussia, PA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Al-Huniti |D Nidal |u Quantitative Clinical Pharmacology, AstraZeneca, Waltham, MA, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Jadhav |D Pravin |u Quantitative Pharmacology and Pharmacometrics, Merck and Co., Whitehouse Station, NJ, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Wang |D Yaning |u Division of Pharmacometrics, US Food and Drug Administration, Silver Spring, MD, USA |4 aut | ||
| 950 | |B NATIONALLICENCE |P 700 |E 1- |a Byon |D Wonkyung |u Global Innovative Pharma Business Clinical Pharmacology, Pfizer Inc., Groton, CT, USA |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), 301-314 |x 1567-567X |q 42:3<301 |1 2015 |2 42 |o 10928 | ||