EXTON, Pa., Oct. 15, 2015 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and safety testing of medical devices, announces the contribution of two of its scientists to a peer-reviewed paper in the highly respected journal Pharmaceutical Research. Chris Bode, Ph.D. (VP, Scientific and Corporate Communications) and Ismael Hidalgo, Ph.D. (Chief Scientist) collaborated with scientists from the Product Quality Research Institute (PQRI), a non-profit consortium representing the U.S. Food and Drug Administration (FDA), industry, and academia. In the paper, several commonly used excipients (inactive ingredients in drug products) were studied for their effects on the absorption of several model drugs.
The paper, "The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers," is available free of charge here: http://link.springer.com/article/10.1007/s11095-015-1773-4?wt_mc=internal.event.1.SEM.ArticleAuthorOnlineFirst. The Biopharmaceutics Classification System, or BCS, is a regulatory pathway enabling waivers of some clinical testing for some drugs under specific circumstances. Using two preclinical models, the authors found that the absorption of the four tested BCS Class III (high solubility, high permeability) drugs was not greatly affected by the tested excipients. The results may have wider implications in supporting biowaivers for BCS Class III drugs in general, which is now allowed per a recent (May 2015) FDA draft guidance.
Ismael Hidalgo, Chief Scientist of Absorption Systems, commented that "This work highlights the possibility of excipient substitution when developing biowaiver-eligible Class III drug products. Our research further demonstrates the utility of non-clinical permeation methods for assessing excipient effects on drug absorption. Incorporating these learnings during the development and review of generics, by manufacturers and regulators, respectively, will increase patients' access to quality interchangeable products."
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. The CellPort Technologies® platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems' commitment to innovation and is soon to be an industry standard for in vitro drug interaction 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 and applied research programs, please visit www.absorption.com.
SOURCE Absorption Systems