Pre-clinical development

Pre-Clinical Development

Pre-clinical development

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Pre-clinical development is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and safety (also known as Good Laboratory Practice or "GLP") data is collected.

The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to determine a product's ultimate safety profile. Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc. Each class of product may undergo different types of preclinical research. For instance, drugs may undergo pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Medical devices that do not have drug attached will not undergo these additional tests and may go directly to GLP testing for safety of the device and its components. Some medical devices will also undergo biocompatibility testing which helps to show whether a component of the device or all components are sustainable in a living model. Most 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.

Typically, both in vitro and in vivo tests will be performed. Studies of a drug's toxicity include which...
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