Non-clinical research, also known as non-clinical trials, refers to experimental studies of drugs or medical devices conducted outside the human body. The main purpose of such studies is to evaluate the safety, efficacy, pharmacokinetic and pharmacodynamic properties of a drug or medical device to provide a basis for subsequent clinical trials.
Nonclinical studies usually include animal testing, in vitro testing, and human sample analysis. Among them, animal testing is the most commonly used non-clinical research method, which evaluates the safety, efficacy and pharmacokinetic properties of a drug or medical device by testing it on animals.
In vitro testing, on the other hand, is the study of drugs or medical devices conducted under laboratory conditions, such as cell culture, tissue sectioning, etc. Human sample analysis, on the other hand, is the testing and analysis of drugs or medical devices in the human body to assess their safety and efficacy.
Nonclinical research plays a very important role in drug discovery and medical device development. First, non-clinical studies can provide a preliminary assessment of the safety and efficacy of a drug or medical device, providing a basis for subsequent clinical trials.
Second, non-clinical studies can assess the pharmacokinetic and pharmacodynamic properties of a drug or medical device, providing important information for drug design and optimization. In addition, non-clinical studies can support the registration application of a drug or medical device to ensure that it complies with relevant regulations and standards.
It is important to note
Non-clinical studies, while providing a preliminary assessment of the safety and efficacy of a drug or medical device, are not a complete substitute for clinical trials. Clinical trials are the most direct method of assessing the safety and efficacy of a drug or medical device in the human body, and therefore clinical trials are often required to further validate the safety and efficacy of a drug or medical device after a non-clinical study has been conducted.
In short, non-clinical studies are an important method of drug and medical device research and development, which evaluates the safety, efficacy, pharmacokinetics, and pharmacodynamics of a drug or medical device through tests and studies conducted outside the human body, and provides a basis for subsequent clinical trials. When conducting non-clinical studies, it is necessary to follow the relevant regulations and standards to ensure the scientific validity and reliability of the studies.