Absorption Systems Registers With FDA As A Generic Drug Facility Under GDUFA
Absorption Systems' activities related to GDUFA involve classification of drug active ingredients according to the BCS. Part of the FDA drug approval pathway since 2000, the BCS classifies drugs according to the solubility and permeability of their active pharmaceutical ingredients (APIs). Absorption Systems is the world leader in the measurement of drug permeability for BCS classification. Drugs that meet the criteria for BCS Class I (high permeability and solubility) are eligible for a biowaiver, which simplifies the process of drug development.
Patrick Dentinger, President and CEO of Absorption Systems, commented that "The world is gradually realizing what a unique and reliable approach to accelerating product approval the BCS is. Whereas GDUFA is expected to reduce the backlog of generic reviews, the BCS eliminates unnecessary human testing and dramatically reduces both the time and cost of product approval."
Collectively, these steps will benefit BCS adopters in the US and around the globe. The interest and growth in BCS applications have regulatory agencies around the world taking notice. With that in mind, Absorption Systems has expanded its support for the burgeoning pharmaceutical industry in Latin America by establishing its facility in Panama, in anticipation of increased demand for BCS-related studies.
About Absorption SystemsAbsorption 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 assay 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@example.com www.absorption.com SOURCE Absorption Systems
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