Before a drug or treatment can be tested on people, clinical researchers should ensure whether it can cause potential risks, side effects, or serious harms, also known as toxicity to the patients. Learn Clinical Research Courses. The two types of preclinical research include the following:
- In Vitro
- In Vivo
In the US, the FDA stipulates that researchers must use good laboratory practices (GLP), as defined in medical product development regulations for preclinical laboratory studies. The GLP regulations set the minimum basic requirements for:
- study conduct
- personnel
- facilities
- equipment
- written protocols
- operating procedures
- study reports
It also establishes a system of quality assurance for each preclinical study to ensure the safety and efficacy of products approved and regulated by the FDA. Generally, preclinical studies are not conducted on a very large scale. However, these studies must provide detailed information on dosing and toxicity levels. Clinical researchers review their results after preclinical testing.
Conclusion
Preclinical studies encompass various activities that serve as a link between drug discovery and preparation and the initiation of a clinical trial on humans. The laws regulating preclinical trial norms and requirements worldwide can package differences but generally have some common features. Rodent and non-rodent mammalian models are generally used to set forth general safety and identify toxicity patterns that reveal potential target organs likely to suffer the adverse effects. Take Clinical Research Training. Toxicology and safety studies also identify Therapeutic Index for deciding the initial starting doses in clinical trials. More than one or more species can be used for determining the drug's mean residence time in the body. The mean residence time of a drug in the body depends on inherent absorption, distribution, metabolism, and excretion properties.
