Nonclinical studies are conducted to characterize the pharmacological activity, pharmacokinetic properties, and potential safety risks of a medicinal product before its administration to humans. The scope of the nonclinical development program is determined on a case-by-case basis, taking into account the characteristics of the active substance, pharmaceutical dosage form, route of administration, therapeutic indication, and available scientific data.

What Does a Nonclinical Development Program Include?Depending on the characteristics of the medicinal product, the nonclinical program may include:
·       pharmacodynamic and pharmacological studies;
·       pharmacokinetic and toxicokinetic studies;
·       general toxicity studies, including single-dose and repeated-dose toxicity studies, as applicable;
·       genotoxicity studies;
·       reproductive and developmental toxicity studies;
·       safety pharmacology studies;
·       local tolerance studies;
·       carcinogenicity studies and other specialized nonclinical investigations, where scientifically and/or regulatorily justified.

Studies intended to support regulatory submissions are conducted in accordance with applicable quality requirements and, where required, the principles of Good Laboratory Practice (GLP).

Originator and Generic Medicinal ProductsFor originator medicinal products, a comprehensive nonclinical development program is established to characterize the pharmacological properties and safety profile of a new medicinal product and to provide the scientific basis for subsequent clinical development.
For generic medicinal products, the required scope of nonclinical studies is determined individually, taking into consideration the properties of the active substance, qualitative and quantitative composition, pharmaceutical dosage form, manufacturing technology, available scientific and regulatory data, and the requirements of the applicable regulatory pathway.

Accordingly, there is no universal set of nonclinical studies applicable to all medicinal products. The scope and design of the nonclinical program should be scientifically justified and tailored to the specific product and its intended regulatory pathway.
How Do We Organize Nonclinical Studies?We provide comprehensive support throughout the nonclinical development process, including:
·       development of the nonclinical study program and overall development strategy;
·       review and assessment of available scientific, toxicological, pharmacological, and regulatory data;
·       selection of qualified contract research organizations (CROs) and testing facilities;
·       coordination of pharmacological, pharmacokinetic, and toxicological studies;
·       oversight of study conduct, project timelines, and deliverables;
·       scientific analysis and expert interpretation of study results;
·       preparation and review of final study reports;
·       preparation of nonclinical documentation for the regulatory submission dossier;
·       scientific and regulatory support for subsequent clinical development.

DeliverablesUpon completion of the project, the client receives a comprehensive package of documentation related to the studies performed, an expert scientific assessment of the results, and the materials required to support the further development and regulatory registration of the medicinal product.

A scientifically justified and appropriately designed nonclinical development program enables the timely identification and characterization of potential safety risks, provides robust data on the pharmacological and toxicological profile of the medicinal product, and establishes a sound scientific basis for progression to first-in-human and subsequent clinical studies.