Bioanalytical Systems, Inc. (NASDAQ:BASI) (“BASi” or the “Company”) today announced a multi-tiered strategy aimed at enhancing the company’s in vitro and in vivo bioequivalence capabilities.
Over the next several months, BASi will hire additional Principal Investigators and Research Analysts to support the company’s Bioanalytical and Pharm Analysis labs, and provide expanded cross training for current staff. Additionally, capital investments are being made for new and upgraded automated dissolution apparatus equipment for the company’s Pharm Analysis labs. These upgrades will not only provide improved data, a commitment at the heart of BASi’s pledge to its clients, but will increase capacity as well. The company will also increase its already extensive library of validated analytical methods applicable to in vivo bioequivalence studies.
BASi has extensive experience in performing in vitro bioequivalence studies as described in regulatory guidances, and demonstrated by successful regulatory audits of the company’s work. BASi is actively engaged in developing new methods to be utilized for recent, new guidances. Some of the products requiring in vitro bioequivalence testing include sevelamer carbonate and hydrochloride, lanthanum carbonate, cholestyramine powder, colesevelam hydrochloride, calcium carbonate, and colestipol.
“BASi’s goal is to be the go-to research organization for bioequivalence studies that provide timely, accurate and precise data for our clients’ regulatory filings,” said James Bourdage, Ph.D., Vice President of Bioanalytical Operations at BASi. “Exceptional leadership, a dedicated and focused scientific team, state-of-the-art equipment in our labs, and expanding our validated methods library will give us the competitive edge we need to reach that goal.”
Peter T. Kissinger, BASi Founder and Scientific Adviser added, “This activity has provided good momentum for BASi in supporting more generic drug applications (ANDAs). Both in animal models and the clinic, our expanded library of assays also facilitates drug-drug interaction (DDI) studies with yet to be approved novel therapeutics.”
About Bioanalytical Systems, Inc.
BASi is a pharmaceutical development company providing contract research services and monitoring instruments to the world’s leading drug development companies and medical research organizations. The Company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit www.BASinc.com for more information about BASi.
This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to changes in the market and demand for our products and services, the development, marketing and sales of products and services, changes in technology, industry standards and regulatory standards, and various market and operating risks detailed in the company’s filings with the Securities and Exchange Commission.