Absorption Systems and Provenir Scientists Address the Challenges of Developing Generic Complex Drug Products
New publications highlight nonclinical approaches to assessing the equivalence of locally acting complex drug products
EXTON, Pa., Jan. 28, 2015 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and safety testing of medical devices, and the expert consulting group Provenir Pharma, jointly announce two new publications on alternative approaches to assessing the equivalence of locally acting complex drug products. The articles are published today in The AAPS Newsmagazine and the AAPS Blog. AAPS is the American Association of Pharmaceutical Scientists.
It has often been difficult to demonstrate bioequivalence for locally acting complex drug products, for a variety of reasons, including lack of systemic distribution in many cases and the fact that the blood compartment is downstream from the therapeutic site, which combine to make it unfeasible and/or invalid to monitor exposure via blood sampling and analysis. This meant that large, expensive trials with clinical endpoints were required; the U.S. Food and Drug Administration (FDA) has acknowledged that this is the least accurate, sensitive, and reproducible approach for demonstrating equivalence.
In order to promote the development of generic versions of such drug products, the FDA has encouraged exploration of alternative methodologies, including nonclinical models, which are more accurate and sensitive. These techniques also offer advantages to innovator companies, during formulation development and to demonstrate equivalence between batches for scale-up and post-approval changes. These alternative nonclinical approaches are the focus of the current cover article in the February issue of The AAPS Newsmagazine and an accompanying post on the AAPS Blog.
Sid Bhoopathy, Chief Operating Officer of Absorption Systems and one of the authors, commented that "These types of studies are what we excel at. It's very gratifying to develop solutions that can benefit pharmaceutical companies and patients alike. A remaining challenge is to build a scientific framework that can extend this concept beyond product type- or mechanism-specific examples."
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.
Chris Bode
Absorption Systems
1-610-280-1451
[email protected]
www.absorption.com
SOURCE Absorption Systems
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