SAN CARLOS, Calif., Feb. 2, 2016 /PRNewswire/ -- Rosa & Co. LLC, the leading commercial drug development advisory firm with expertise in Quantitative Systems Pharmacology (QSP)/PhysioPD™, today announced the publication by Dr. Christina Friedrich, "Model Qualification Method for Mechanistic Physiological QSP Models to Support Model-Informed Drug Development" in the CPT: Pharmacometrics & Systems Pharmacology Journal.
QSP is being used increasingly by innovative R&D organizations as a powerful research approach that combines available data with scientific knowledge and engineering approaches to facilitate better understanding of biological systems, to improve decision-making, and to reduce risk and increase efficiency in drug discovery and development. Dr. Friedrich's tutorial draws on years of experience to generate a rigorous, systematic, and broadly applicable Model Qualification Method (MQM) to ensure that QSP models are well-qualified and fit for their intended purposes. The MQM addresses questions of model relevance, scope, uncertainty, biological variability, and use of data, so that model-informed research can proceed with confidence. The article can be downloaded here.
"We are pleased to make this contribution to the evolution of QSP methodologies. We believe this tutorial will facilitate greater adoption and more confident use of QSP models in the pharmaceutical industry."
-Dr. Christina Friedrich, Chief Engineer, Rosa & Co. LLC
Rosa supports clients with their critical decisions – from preclinical through clinical development – by creating and using customized PhysioPD™ Research Platforms that connect mechanisms to outcomes. PhysioPD Platforms are used to simulate normal and disease physiology, drug action, patient variability, and trial outcomes. Rosa's clients are involved in Platform creation, testing, and biological simulation research. Clients retain the Platform as a program asset to support decisions and future research. Rosa's staff has unparalleled professional experience applying biological modeling and simulation research to accelerate drug development and has over 13 years of client engagements in virtually all therapeutic areas. Rosa is unique in its breadth and depth of disease area experience, including metabolic diseases, immuno-oncology, oncology, cardiovascular, inflammation, immune dysfunction, central nervous system disorders, dermatology, rare disease, and antibacterial/antiviral biology. For more information, visit http://www.rosaandco.com/news.html.
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