Experimental Design

动物实验设计

我们的专家团队提供全面的临床前动物实验设计服务，注重科学严谨性和伦理考量。我们开发稳健的实验方案，优化实验程序，并为委托方提供量身定制的咨询服务。

Our expert team provides comprehensive pre-clinical animal experiment design services with a focus on scientific rigor and ethical considerations. We specialize in developing robust protocols, optimizing experimental procedures, and offering tailored consultations to sponsors.

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Safety and Efficacy Evaluation

安全与有效性评估

医疗器械安全性和有效性评估研究应采用科学、合理的方法，其中动物实验是不可或缺的环节。动物实验的主要目标是初步评估医疗器械的安全性、有效性和可行性，具有多重关键意义。

The main objectives of animal experiments are to preliminarily assess the safety, efficacy, and feasibility of medical devices, which have the following key significance:

Provide empirical support for product design optimization;
Offer scientific basis for medical devices to enter the clinical research phase, ensuring the safety of trial participants;
Provide important reference for deciding whether clinical trials can be exempted or for developing clinical trial protocols.

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3R Principle

对于需要进行动物实验的产品，应制定严谨的实验方案，遵循动物实验学的"3R原则"：替代（Replacement）、减少（Reduction）和优化（Refinement）。

For products requiring animal experiments, a rigorous experimental protocol should be established. During the design process, researchers need to follow the "3R Principle" of animal experimentation: Replacement, Reduction, and Refinement.

Select qualified animal experiment facilities to ensure they possess the necessary qualifications and a comprehensive quality management system.
Scientifically design the experimental protocol, with animal selection and assessment indicator settings based on sufficient scientific evidence.
Consider whether in vitro experiments are necessary based on product characteristics, and fully consider various precautions in acute and chronic experiments.

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