High-quality, cost-effective preclinical product development solutions

Smith, Maree (2009). High-quality, cost-effective preclinical product development solutions. In: BIO Korea 2009, Seoul, Korea, (). 16-18 September 2009.

Author Smith, Maree
Title of paper High-quality, cost-effective preclinical product development solutions
Conference name BIO Korea 2009
Conference location Seoul, Korea
Conference dates 16-18 September 2009
Place of Publication Seoul, Korea
Publisher BIO Korea 2009
Publication Year 2009
Sub-type Published abstract
Total pages 1
Language eng
Abstract/Summary In the global biopharmaceutical industry, it is increasingly recognized that small, nimble biotechnology companies are the major source of innovation in terms of new pharmaceuticals development. As many small biotechs are university spin-outs with only one or two employees, these companies, by necessity, conduct their new drug development activities using an outsourcing model. TetraQ is a GLP-accredited Queensland-based provider of high quality, cost-effective preclinical drug development services to biopharmaceutical companies located in Australia and internationally. At TetraQ, our great technical strength, wealth of experience and high quality science with no short cuts, enables us to add significant value in assisting early-stage biotechnology companies to take their lead molecules from the discovery laboratory through the key stages of non-clinical development. Our preclinical drug development services include efficacy assessment in validated animal models of human disease with specialist expertise in preclinical pain models, bioanalytical method development and validation to satisfy the rigorous requirements of the FDA, animal pharmacokinetic studies, in vitro metabolism studies using hepatocytes and microsomes as well as GLP toxicology studies. In the past four years, TetraQ has conducted > 300 preclinical R&D contracts for more than 70 clients. Our GLP-recognition from the National Association of Testing Authorities (NATA) in Australia for the provision of bioanalytical and toxicology services means that the data generated at TetraQ will be accepted for review by international regulatory agencies. Apart from conducting preclinical R&D studies, TetraQ also provides GLP bioanalysis and pharmacokinetic analysis services to support clinical trials including those undertaken by our strategic alliance partner, Q-Pharm Pty Ltd. At TetraQ, we have more than 130 fully validated bioanalytical methods on hand involving methodological approaches as diverse as HPLC-MS/MS, ELISA and Ha/Ha assays. We have considerable experience in the establishment and validation of animal efficacy models in response to client request thereby adding another dimension to our organisation. Case studies will be presented.
Q-Index Code EX
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Conference Paper
Collection: School of Pharmacy Publications
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Created: Fri, 05 Aug 2011, 16:49:54 EST by Mary-Anne Marrington on behalf of School of Pharmacy