Absorption Systems Embarks On Research Collaboration With The FDA
Published: Sep 20, 2017
EXTON, Pa., Sept. 19, 2017 /PRNewswire/ -- Absorption Systems, a global leader in translational medicine and pharmacokinetic testing of drugs, announces a formal Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA). The goals are to improve the FDA's ability to predict canine oral drug product absorption characteristics and to help identify factors that influence canine oral drug product performance. And because the dog is a pre-clinical model used in human drug development, the results of this project will support the science of translational medicine, benefitting the development of human drugs as well. The parties expect that the results of the collaboration will eventually be made public in the form of published manuscripts, posters, and oral presentations.
Under the agreement, Absorption Systems will share available data on drug pharmacokinetics in dogs, as well as data from various specialized models used for predicting bioavailability, with the FDA's Center for Veterinary Medicine (CVM), the division of the agency that is tasked with approval of drugs for use in animals. Additionally, data from an in vivo model such as the Chronic Intestinal Access Port, which can be used for in vivo dissolution and to identify barriers to bioavailability, may be complemented with results generated with the patented In Vitro Dissolution and Absorption System (IDAS) apparatus to augment the understanding of canine drug absorption considerations.
FDA scientists, in turn, will incorporate the data into sophisticated computer models, which provide in silico simulations of the absorption, distribution, metabolism, and elimination of drugs in vivo. Because many of the tools that have been developed to model drug behavior in humans do not exist for dogs, the Absorption Systems data set will be particularly valuable in ongoing modeling and simulation projects. In fact, the expectation is that the ability to predict and confirm drug performance, as opposed to iterative evaluations for new drugs, will reduce the number of animals required in future testing.
Sid Bhoopathy, Chief Operating Officer, commented that, "This collaboration exemplifies many of the things that drive us every day: scientific exchange, regulatory science, translational medicine, and ultimately, the development of better, safer drugs. We're looking forward to seeing where this leads us, down the road."
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. IDAS2, a novel in vitro test system for simultaneous screening of drug absorption and dissolution, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry standard for formulation assessment. Absorption Systems, with facilities near Philadelphia, PA, in San Diego, CA, and in Panama, serves customers throughout the world. For information on the company's comprehensive contract services, applied research programs, and proprietary test systems, please visit www.absorption.com.
SOURCE Absorption Systems