Preclinical research includes product API development, process, dosage form and animal toxicity testing. The ultimate goal of the drug is to prove effective in the patient, but to be on the safe side, the animal must prove its efficacy and safety. To this end, a number of tests have to be completed before human clinical trials can be submitted to health authorities for investigational new drugs (INDs), which are audited and then run on clinical trials. The following is a brief description of the research and development projects required by IND.
Chemical Manufacture and Control (CMC): Massive manufacturing of compounds, purity analysis, physico-chemical properties, stability testing, formulation design, and more.
Pharmacokinetics (PK): Understanding how drugs are absorbed, distributed, metabolized, and excreted in the body provides information on the route of administration for future clinical trials (eg, oral, injection, inhalation, etc.).
Safety Pharmacology: In order to assess the effects beyond the efficacy, animal safety pharmacological tests are required to understand possible side effects, especially cardiovascular, respiratory, central nervous, and the like.
Toxicology: Toxicology quite a wide range of types, including: acute toxicity, subacute toxicity, chronic toxicity, reproductive toxicity, carcinogenicity, mutagenicity and so on. In order to speed up the early detection of new drugs have a curative effect, some time-consuming and costly toxicology experiments (such as carcinogenicity, reproductive toxicity) is allowed to perform in the first and second phase of clinical trials.
For these preclinical work, Vivasolis Biotech will be commissioned by Contract Research Organization (CRO), a commissioned research institute or company with this specialized facility and experience, to save as much research agency funding as possible and to maintain our business flexibility. When the pre-clinical trial is completed, all the entrusted units can collect the experimental results, literature and other information to apply to the drug agency IND, the information usually includes: drug source composition, manufacturing methods and specifications, pharmacology and toxicology of various animal experiments , Pharmacokinetics, clinical trial program book and executor.