In Vitro Drug Development Services
Quality outsourced services for fast, accurate results
CellzDirect offers a variety of in vitro development services at our state-of-the-art facilities located in Austin, Texas and Research Triangle Park, North Carolina.
Our clients use our in vitro metabolism and drug-drug interaction services to:
• interpret preclinical animal results
• help design clinical studies
• satisfy FDA requirements
• address post-market drug interaction findings
Superior templated and customized services
CellzDirect has exceptional experience in the design and implementation of in vitro studies, data analysis and interpretation. Our exclusive tissue procurement program coupled with our ability to consistently isolate high quality human hepatocytes and microsomes assures our clients of rapid turn-around and superior results. Due to our continuing collaborations with academic and industry partners and our relationship with the FDA, we are constantly refining our services and processes, incorporating the most advanced hepatic research.
CellzDirect offers standard templated study designs based on our experience and FDA requirements; however, our strength is in customizing studies to address our clients’ specific issues. Our staff excels at designing the most appropriate study based on a client’s questions and prior experiences. For information on FDA requirements for in vitro study designs, contact us, or visit these FDA websites:
*INITIAL FDA DDI GUIDANCE (1997) http://www.fda.gov/cder/Guidance/clin3.pdf
*CURRENT DRAFT FDA DDI GUIDANCE (2006) http://www.fda.gov/cder/guidance/6695dft.pdf
The Finest Scientific Minds at Work
Our team of scientists, headed by Chief Scientific Officer Dr. Edward LeCluyse, is highly trained in hepatic and metabolism-based research and has published dozens of papers focused on hepatocyte isolation and culture, metabolism-based drug-drug interactions, and related areas.
Committed to Good Laboratory Practices
Good Laboratory Practices (GLP) is an integral part of CellzDirect operations, which recognizes the importance of GLP as defined by FDA regulations 21 CFR 58. Having participated in more than 100 corporate audits over the past 13 years, CellzDirect’s scientists have established and refined our standard operating procedures to be unsurpassed in the industry. CellzDirect’s documentation and audit tracking provide seamless assurance that clients’ studies are conducted under the most rigorous scrutiny and to the highest standards.
