Preclinical research is one of the stages of development of a new drug. They are drug trials on animals. They are carried out in order to eliminate or minimize adverse effects when using the drug by people. Preclinical studies of drugs allow early filtering out of drugs that are too toxic and unsafe.
Conducting pre-clinical studies of drugs is a time-consuming process. But it is necessary to calculate the starting dose to study the properties of the drug in humans. Preclinical studies of drugs should give positive results for the subsequent initiation of clinical trials. An important difference in the preparation of these two stages is that pre-clinical studies do not require the approval of the ethics Committee, which in the case of clinical trials considers all the issues of ethics and morality of the project and protects the rights of its participants. The ethics Committee is not directly interested in the study and independently evaluates all past test materials and medical records of the planned study. Placebo-controlled studies are considered to be the most difficult examinations for the ethical Committee.
Clinical and preclinical studies of drugs are an important element in the development of the pharmaceutical industry. Their conduct is strictly regulated by the requirements of regulatory authorities.
According to statistics, only 2.5% of candidate projects are at the stage of preclinical studies. Organization of preclinical studies can be carried out by CRO.
Preclinical and clinical studies of drugs should be conducted in accordance with all regulatory requirements. The ultimate goal of the research is to launch it on the market. To do this, the drug must be registered. Multiple studies within the same phase may be required for registration. The number of patients or healthy volunteers for each study is determined by the biostatistics who calculate the required sample size. The number of patients to be recruited to participate in the study affects the number of research centers involved and, accordingly, the cost of the study.
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