Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to determine a drug's pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Pre-clinical studies must adhere to Good Laboratory Practices (GLP) in ICH Guidelines to be acceptable for submission to regulatory agencies such as the Food & Drug Administration in the United States.
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