To conduct preclinical testing of locally-acting topical dermal and ophthalmic drug product formulations
EXTON, PA – October 09, 2019 – Absorption Systems, a global leader in translational medicine, pharmacokinetic testing of drugs, and cell and gene therapy, announces that it has been awarded a 5 year IDIQ (Indefinite Delivery Indefinite Quantity) contract, for a total amount of $3.5 million, by the U.S. Food and Drug Administration (FDA). The objective is to support FDA’s development and refinement of drug product approval standards for locally-acting topical dermal and ophthalmic drug product formulations.
Under the contract, Absorption Systems will develop and conduct appropriate in vitro release tests (IVRT) and in vitro permeability test (IVPT), in accordance with published FDA guidance documents. The company will also perform in vivo studies to evaluate the pharmacokinetics, distribution, and efficacy of topically administered drugs that act locally on the skin or in the eye. Ultimately, fulfillment of this contract will help ensure that safe, effective, and high-quality complex generic drugs are available to the public.
Locally acting complex drugs are particularly challenging for drug regulators to evaluate because they may not be absorbed or may be absorbed in such small amounts that it is not feasible to simply compare plasma levels to determine whether two products are bioequivalent, as can be done with orally administered drugs. This award recognizes the core strength of Absorption Systems as a developer of biopharmaceutics tools that can predict human outcomes. These next-generation technologies improve our fundamental understanding of how the critical quality attributes (CQAs) of formulations affect the local and/or systemic pharmacokinetics and pharmacodynamics of drugs. This, in turn, contributes to the establishment of in vitro-in vivo correlation (IVIVC) or in vitro-in vivo relationship (IVIVR) models to help ensure the bioequivalence of complex drug products.
Vatsala Naageshwaran, Senior Vice President of Operations of Absorption Systems, commented “As a testing facility we have focused on the increased utilization of biopharmaceutics principles, advances in non-clinical tools for guiding formulation strategy and predicting in-vivo performance, and demonstrating product equivalence without the need for clinical studies. The FDA has prioritized research to investigate reliable and reproducible scientific tools to help understand chemical and biological complexity and establish surrogate models that are predictive of clinical performance. Our goal is to support these efforts, to enable significant regulatory outcomes in categorizing appropriate paths for development and approval thereby enhancing patient access to generic ophthalmic and topical drug 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. 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 Medford, MA, 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.