RESUMEN
The recently enacted Prescription Drug User Fee Act (PDUFA) VI includes in its performance goals "enhancing regulatory science and expediting drug development." The key elements in "enhancing regulatory decision tools to support drug development and review" include "advancing model-informed drug development (MIDD)." This paper describes (i) the US Food and Drug Administration (FDA) Office of Clinical Pharmacology's continuing efforts in developing quantitative clinical pharmacology models (disease, drug, and clinical trial models) to advance MIDD, (ii) how emerging novel tools, such as organ-on-a-chip technologies or microphysiological systems, can provide new insights into physiology and disease mechanisms, biomarker identification and evaluation, and elucidation of mechanisms of adverse drug reactions, and (iii) how the single organ or linked organ microphysiological systems can provide critical system parameters for improved physiologically-based pharmacokinetic and pharmacodynamic evaluations. Continuous public-private partnerships are critical to advance this field and in the application of these new technologies in drug development and regulatory review.
Asunto(s)
Evaluación Preclínica de Medicamentos/instrumentación , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Dispositivos Laboratorio en un Chip , Farmacología Clínica/instrumentación , Ingeniería de Tejidos , Humanos , Estados UnidosRESUMEN
The impact of robotics and automation on the pharmaceutical industry over the last two decades has been significant. In the last ten years, the emphasis of laboratory automation has shifted from the support of manufactured products and quality control of laboratory applications, to research and development. This shift has been the direct result of an increased emphasis on the identification, development and eventual marketing of innovative new products. In this article, we will briefly identify and discuss some of the current trends in laboratory automation in the pharmaceutical industry as they apply to research and development, including screening, sample management, combinatorial chemistry, ADME/Tox and pharmacokinetics.