Regulatory requirements for preclinical studies are established by regulatory agencies such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory bodies. These requirements are designed to ensure that preclinical studies are conducted in a safe, ethical, and scientifically sound manner, and that the data generated are reliable and accurate.

The regulatory requirements for preclinical studies typically include the following:

1. Good laboratory practices (GLP): GLP is a set of regulations that govern the conduct of preclinical studies. GLP regulations cover all aspects of the study, including study design, data collection, record keeping, and reporting. GLP compliance ensures that the study is conducted according to established standards, and that the data generated are reliable and accurate.
2. Study design and protocol: Preclinical studies must be designed and conducted in accordance with established standards and protocols. The study design and protocol must be clearly defined and documented, and must be approved by an institutional animal care and use committee (IACUC) or similar regulatory body.
3. Animal welfare: The use of animals in preclinical studies must be conducted in accordance with established ethical standards and guidelines. The animals must be housed, fed, and cared for in a manner that ensures their welfare, and all procedures must be approved by an IACUC or similar regulatory body.
4. Safety evaluation: Preclinical studies must include a comprehensive safety evaluation of the substance being tested. The safety evaluation typically includes acute toxicity studies, sub-acute toxicity studies, and chronic toxicity studies, as well as genotoxicity and carcinogenicity studies.
5. Quality control and assurance: Preclinical studies must include robust quality control and assurance measures to ensure that the study is conducted according to established standards and that the data generated are reliable and accurate.
6. Reporting: Preclinical studies must be reported in a clear and transparent manner, with all methods, data, and results clearly documented. The results of the study must be interpreted in a scientifically sound manner, and the conclusions must be supported by the data.

Overall, regulatory requirements for preclinical studies are designed to ensure that the study is conducted in a safe, ethical, and scientifically sound manner, and that the data generated are reliable and accurate. These requirements include GLP compliance, study design and protocol, animal welfare, safety evaluation, quality control and assurance, and reporting.