Forensic Pharmacometrics: Part 2 – Deliverables for Regulatory Submission

Authors: Grasela TH, Fiedler-Kelly J, Ludwig E, Passarell JA, Hitchcock D
Conference: PAGE
Keywords: analysis-ready, assessment, compliance, critical path, data analysis plan, data assembly, dataset, decision-making, deliverables, documentation, drug development process, due diligence, EMEA. FDA, final technical reports, forensic pharmacometrics, gap analysis, NONMEM, PK/PD methodology, quality assurance, regulatory, standards, strategic, validation
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Abstract

Introduction: As modeling and simulation results become increasingly integral to critical development-related decision-making and program outcomes, the consequences of poor documentation of pharmacometric analyses can jeopardize the role of pharmacometrics in contributing to the transition to model-based drug development. While the EMEA and FDA Population PK Guidance documents recommend pharmacometric report content, forensic assessment of analysis inputs and outputs may enable the development of standards to define measures of acceptability and support the continued evolution of these methods.

Population Approach Group in Europe (PAGE), Berlin, Germany, June 2010

By Thaddeus H. Grasela, Jill Fiedler-Kelly, Elizabeth Ludwig, Julie Passarell, Darcy Hitchcock