Non-clinical studies

InfoLex provides full list of services in organization and performance of nonclinical studies of generics. They include:

• search and selection of study center;
• preparation of protocol, consultations with leading experts on agreement of necessary study size and choice of experimental model;
• organization of experiment and statistical data processing;
• presentation of documents;
• expert evaluation of the results obtained.

In case of studies of generics, nonclinical studies include determination of general toxic properties (acute and subacute (subchronic) toxicity.

The following parameters should be studied for original products and biosimilars:

• specific types of toxicity (mutagenicity, reproductive toxicity, carcinogenicity, allergenic effect, immunotoxic effect);
• pharmacological safety;
• specific pharmacological activity;
• pharmacokinetics.

InfoLex closely cooperates with leading research centers and has wide practical experience. We propose you honest business, successful performance of work within the shortest periods and optimal prices.