AniClin specializes in preclinical drug development support for the pharmaceutical, biotech, and medical device industries. We are experts in pharmacology and the preclinical research necessary to support first in human clinical trials.
Following the discovery of a new chemical entity (NCE) the optimized lead compound is subjected to a development process that includes pharmacological studies of the NCE and its effects on pharmacodynamics, pharmacokinetics, toxicity, carcinogenicity, mutagenicity and reproductive development. The data is reviewed by the Food and Drug Administration for determination of safety and effectiveness of the NCE as a potential drug. The data is necessary for the Investigational New Drug (IND) submission and for clearing the NCE for first in human clinical studies.
AniClin offers a comprehensive scope of services that study these important development milestones for a NCE. AniClin Sponsors seeking preclinical testing can have all the necessary GLP studies completed to support their IND submission, by the diverse and experienced scientific staff at AniClin.
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