FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective
Jane P. F. Bai, Brian J. Schmidt, Kapil Gadkar, Valeriu Damian, Justin Earp, Christina Friedrich, Piet H. van der Graaf, Rajanikanth Madabushi, Cynthia J. Musante, Kunal Naik, Mark Rogge, Hao Zhu
Topics & Concepts
CredibilityComputer scienceWorkflowFlexibility (engineering)Drug developmentRisk analysis (engineering)Scope (computer science)Process managementTraceabilityManagement scienceSoftware engineeringMedicineEngineeringDrugPharmacologyMathematicsDatabasePolitical scienceStatisticsLawProgramming languageStatistical Methods in Clinical TrialsHealth Systems, Economic Evaluations, Quality of LifeComputational Drug Discovery Methods