Preclinical studies on a medical device, drugs, biologically active additives – studies which are carried out on animals to get a positive result regarding the use of one or another medical device, drug or a biologically active additive. All preclinical studies of drugs are based on such research aspects as:
— acute toxicity;
— chronic toxicity;
— local irritance;
— pharmacological activity.
Less frequently:
— subacute toxicity;
— carcinogenicity;
— fertility.
After completion of successful preclinical studies, as a rule, clinical studies are started, and efficacy is already examined. Specialists of our company may also help you in arrangement and conduct of clinical studies (See Clinical studies of a medical device, drugs, biologically active additives).
Aim of preclinical studies on biologically active additives, drugs, medical devices — to confirm safety of a study product. Schemes of drug studies may be various and depend on the composition and therapeutic indications. Our specialists will help you to determine a more economic but an effective study.
As well, specialists of our company will help you in further product registration, see more details in section: Drug registration, Registration of medical devices, Registration of biologically active additives.