The purpose of this work was to develop a\nconsolidated set of guiding principles for reporting of\npopulation pharmacokinetic (PK) analyses based on input\nfrom a survey of practitioners as well as discussions between\nindustry, consulting and regulatory scientists. The\nsurvey found that identification of population covariate\neffects on drug exposure and support for dose selection\n(where population PK frequently serves as preparatory\nanalysis to exposureââ?¬â??response modeling) are the main areas\nof influence for population PK analysis. The proposed\nguidelines consider two main purposes of population PK\nreports (1) to present key analysis findings and their impact\non drug development decisions, and (2) as documentation\nof the analysis methods for the dual purpose of enabling\nreview of the analysis and facilitating future use of the\nmodels. This work also identified two main audiences for\nthe reports: (1) a technically competent group responsible\nfor in-depth review of the data, methodology, and results,\nand (2) a scientifically literate, but not technically adept\ngroup, whose main interest is in the implications of the\nanalysis for the broader drug development program. We\nrecommend a generalized question-based approach with\nsix questions that need to be addressed throughout the report.\nWe recommend eight sections (Synopsis, Introduction,\nData, Methods, Results, Discussion, Conclusions,\nAppendix) with suggestions for the target audience and\nlevel of detail for each section. A section providing general\nexpectations regarding population PK reporting from a\nregulatory perspective is also included. We consider this an\nimportant step towards industrialization of the field of\npharmacometrics such that non-technical audience also\nunderstands the role of pharmacometrics analyses in decision\nmaking. Population PK reports were chosen as representative\nreports to derive these recommendations;\nhowever, the guiding principles presented here are applicable\nfor all pharmacometric reports including PKPD and\nsimulation reports.
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