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In Vitro Evaluations per FDA Guidelines:
The mission of ImQuest is to provide solutions to complex drug discovery and development problems that will result in the rapid and efficient progression of therapeutic agents to human clinical trials.
The staff of ImQuest BioSciences has decades of experience with the efficient and cost-effective development of anti-infective therapeutics. Drugs, vaccines, immune modulators, proteins and peptides, small molecules, and other biologics have been discovered and developed in our laboratories. Our work begins with basic drug discovery screening programs and then follows a well defined and understood developmental pathway, guided by the Points To Consider documents of the Food and Drug Administration (FDA) (Points to Consider in the Preclinical Development of Antiviral Drugs for the Treatment of HIV Infection, Points to Consider in the Preparation of IND Applications for New Drugs Intended for the Treatment of HIV-Infected Individuals).
Our scientists have worked with academic, federal and commercial clients to successfully develop a wide variety of therapeutic agents. Our laboratory-generated data and technical project reports have been subjected to rigorous evaluation by the FDA, leading to the successful entrance of therapeutic agents into human clinical trials. ImQuest will join your research team to help support new or existing therapeutic development projects.
The successful development of an anti-infective compound requires the accumulation of high quality data from a wide variety of laboratory assays. ImQuest carefully monitors the FDA (and its worldwide counterparts) to be fully cognizant of the range and detail of scientific data that will be required to progress a therapeutic agent to a human clinical trial. At present, our diverse offerings allow us to evaluate the efficacy and toxicity of therapeutic agents in relevant human in vitro and in vivo infection models.
Our ability to evaluate the range of action of therapeutic candidates, to precisely define the mechanism of action of an agent, to comparatively evaluate the ability of agents to yield strains of virus resistant to therapy and to evaluate the potential advantages and disadvantages of the use of combination chemotherapy provide a wealth of required information that will facilitate the design and development of a human clinical trial. Further, ImQuest BioSciences's animal model capabilities and safety assessment programs will yield additional information required for your Investigational New Drug application (IND). |
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Efficacy and Toxicity |
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Range of Action |
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Mechanism of Action |
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Combination Assays |
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Resistance Selection and Characterization |
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| Copyright © 2006, ImQuest BioSciences. | | | |
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