Preclinical Studies

Preclinical studies (PCS) are the foundation of drug safety and quality. Preclinical studies are the first and, at the same time, the most important stage in bringing a new pharmaceutical product to market. The quality and scope of the tests performed directly affect the subsequent drug registration process and ensure the safety of people involved in later clinical studies.

From the moment the idea to create a new drug is formed, its development is inseparable from screening preclinical studies. Such studies make it possible to assess the efficacy of a substance or combination and to choose the most suitable composition of the future drug. Once the drug’s composition is approved, preclinical safety and efficacy studies are performed.

Preclinical safety studies of drugs aim to reveal the possible harmful effects of a drug and to evaluate the safety of its use. Such studies are conventionally divided into two large blocks:

1. General toxicity studies, which include the assessment of acute, subchronic and chronic toxicity. At this stage toxic doses are identified and the main organs and systems susceptible to the damaging effect of the pharmacological agent are revealed.
2. Specific toxicity studies, which aim to detect reproductive toxicity (embryotoxicity, teratogenicity, effects on the generative function), allergenicity, immunotoxicity, mutagenicity and carcinogenicity of the pharmacological agent.

Preclinical efficacy studies of drugs assess the pharmacological activity of a candidate drug in the treatment of a specific disease, as well as the drug’s pharmacodynamic properties. This type of study is performed in animal disease models and is the basis for developing the indications and the design of subsequent clinical studies.

To select doses and dosing regimens, pharmacokinetic preclinical studies are performed, including studies of absorption, distribution, metabolism and elimination of the drug. These preclinical studies are also an indispensable part of the bioequivalence assessment of a generic drug.

Today, research centers have a considerable arsenal of methods to assess toxicity and pharmacological activity. Regardless of the scope of a preclinical study, reliable and reproducible data are guaranteed by observing GLP and GCP principles.

Granconsult offers a full range of services for organizing GLP preclinical studies of original and generic drugs and pharmaceutical substances:

• Selection of the site for preclinical studies;
• Drafting the preclinical study statement of work. Agreement of the model and study scope with the research-center specialists;
• Development of the preclinical study protocol;
• Monitoring and quality assurance;
• Statistical processing of the study results;
• Preparation of study reports.

Our company works closely with test centers, which allows us to optimize and reduce preclinical-study timelines and costs. Detailed cost estimates and timelines make every study transparent and clear for you.