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Preclinical CRO-The Safety Evaluation is the Main Sector

2021-03-02
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The safety evaluation is the main sector, and the certification qualification and the area of the laboratory are hard indicators

Pre-clinical research services include safety evaluation research, pharmacokinetics, pharmacology and toxicology, animal models, etc. This stage is mainly to conduct laboratory research and live animal research on lead compounds under laboratory conditions to observe their effects. The biological activity of the target disease, and the evaluation of drug safety and drug toxicology. In addition, pre-clinical CRO companies also provide chemical synthesis outsourcing production services in addition to R&D to meet the needs of a large number of drugs for clinical trials, including drug synthesis technology, separation and purification, dosage form selection, prescription screening, inspection methods, etc. In 2019, the global and Chinese preclinical CRO market scales were 9.1 billion U.S. dollars and 1.8 billion U.S. dollars, respectively, and the 2015-2019 CAGR was 7.9% and 20.3%, respectively.

safety evaluation
Safety Evaluation

Non-clinical safety evaluation research is the largest market segment in the pre-clinical CRO market, which includes safety pharmacology tests, single-dose toxicity tests, repeated-dose toxicity tests, toxicokinetics tests, reproductive toxicity tests, and genotoxicity tests , Carcinogenic test, local toxicity test, immunogenicity test and other evaluation tests.

Among them, the toxicity experiment program obtains the toxicity characteristics of the tested drug by observing the reaction of the experimental animal to the drug over a long period of time, testing the samples collected during the experiment, and pathological examination of the animal specimen.

The pharmacokinetic experimental process plan is to administer the drug to the test animal one or more times, and then collect blood samples of the test animal at a series of time points, detect the drug concentration in the blood sample, and calculate the test results to determine the recipient. The pharmacokinetic characteristics of the test drug.

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