Brendan Technologies CTO To Make Presentation to Regulatory Organization on Drug Release Testing
Dr. John Dunn, founder and chief technical officer of Brendan Technologies, Inc. (BDTE.OB, www.brendan.com), an innovative analytical software company, has been invited by the United States Pharmacopeia (USP) to make a presentation at its USP Bioassay Workshop. The event will be held at the USP Headquarters in Rockville, Maryland, August 13 – 14, 2008.
The USP is the official public standards-setting authority for all prescription and over-the-counter medicines sold in the United States. Dr. Dunn’s presentation will focus on the three methods currently used by the industry for critical drug potency tests that are required for drug release testing. Dr. Dunn made a presentation on the same topic at the IBC Biological Assay Development and Validation conference in San Francisco in May 2008. He has also been working with members of the European Pharmacopeia on this topic.
Brendan has incorporated all three methods used under discussion in its new STATLIA Quantum software. Brendan developed one of the methods, which uses a powerful new statistical approach, to solve the limitations of the other methods. Dr. Dunn and Dr. Paul Gottschalk, Brendan’s product development director, published a paper on this method titled “Measuring Parallelism, Linearity, and Relative Potency in Bioassay and Immunoassay Data,” in the Journal of Biopharmaceutical Statistics in 2005. One of the top twenty pharmaceutical companies made a presentation on its use of this method during the Biological Assay conference. Both presentations are available on Brendan’s Web site, www.brendan.com.
Brendan has been an innovative leader in the computation and analysis of immunoassays and bioassays, developing and perfecting several new methodologies and analytical processes. STATLIA provides an advanced graphical presentation of the analysis and an automated design that saves time in the life science markets and drug development process by increasing productivity and improving assay performance through better accuracy and analysis.
Background on Immunoassay Testing
Immunoassays are highly sensitive and specific chemical tests used to detect and quantify extremely minute substances in blood, body fluid and other biological samples, using an immunological reaction. These tests measure the formation of antibody-antigen complexes and detect them via an indicator reaction. Their high specificity results from the use of antibodies and purified antigens as reagents. High sensitivity is achieved by using an indicator system that results in amplification of the measured product. Immunoassays may be qualitative (positive or negative) or quantitative (amount measured).
Immunoassays are one of the world’s largest and fastest growing testing technologies used to diagnose diseases, discover new chemical entities and biological products, provide vital data in the development of drugs in FDA clinical trials, and assist in quality control of drug manufacturing and drug screening. It is also one of the largest technologies used in environmental testing. Currently, $50 billion is spent globally on immunoassay testing, with approximately $1 billion of that being spent on immunoassay software.
About Brendan Technologies, Inc.
Brendan Technologies, a developer and marketer of innovative analytical software, is actively providing software solutions to improve the accuracy, quality control, workflow, and regulatory compliance of immunoassay and bioassay testing in laboratories in the biopharmaceutical, clinical, research, veterinarian and agricultural industries. The Company’s customers, many of whom are Fortune 1000 organizations, represent some of the largest corporations in their respective fields. Brendan Technologies is continually redesigning and expanding its product lineup to better capitalize on the growing demand of its target markets for more advanced software.