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US 20080083041A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0083041 A1 (43) Pub. Date: Santino, JR. et al. (54) PRECLINICAL ANIMAL TESTING METHOD (75) Apr. 3, 2008

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What is pre-clinical animal testing method?

Pre-clinical animal testing is a methodology used in the evaluation of potential medical treatments or interventions before they are tested on humans. It involves testing on animals to determine the safety and efficacy of a particular drug or treatment.

Who is required to file pre-clinical animal testing method?

Pharmaceutical companies, research institutions, and other organizations involved in the development of new medical treatments are often required to file pre-clinical animal testing methods as part of the regulatory process.

How to fill out pre-clinical animal testing method?

The exact process for filling out pre-clinical animal testing methods may vary depending on the regulatory agency or country. Generally, it involves providing detailed information about the study design, animal species used, dosages administered, and observed effects or outcomes. It is advisable to consult the specific guidelines or regulations applicable to the jurisdiction in question.

What is the purpose of pre-clinical animal testing method?

The purpose of pre-clinical animal testing methods is to evaluate the safety and efficacy of potential medical treatments or interventions before they are tested on humans. This helps to identify any potential adverse effects and determine appropriate dosages for subsequent human clinical trials.

What information must be reported on pre-clinical animal testing method?

Pre-clinical animal testing methods typically require reporting of key information such as study design, animal species used, dosages administered, observed effects or outcomes, and any adverse reactions. Additional information may include the rationale for the study, ethical considerations, and statistical analysis methods.

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