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Preclinical Data Requirements

Meaning

Preclinical data requirements refer to the essential body of scientific information and experimental results, primarily derived from in vitro studies and animal models, that must be collected and analyzed before a novel therapeutic compound, such as a peptide or hormone, can be ethically and legally tested in human subjects. These requirements mandate comprehensive studies on the compound’s toxicology, pharmacokinetics, pharmacodynamics, and efficacy to establish a preliminary safety profile and justify the rationale for human clinical trials. Satisfying these data requirements is a mandatory step in the regulatory process for drug development.