Foundations of Non-Clinical Development

During (early) drug development, non-clinical studies (or pre-clinical studies) are performed to assess the safety and efficacy of drug candidates. The aim of these studies is to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties for dosing strategies and toxicity (including geno-, repro- and immunotoxicity) and toxicokinetics (TK).

The non-clinical development process will determine whether a drug candidate is viable. This process involves multiple steps, including determining PK parameters, Distribution, Absorption, Metabolism, and Elimination (ADME). Furthermore, the safety of the drug candidate and its tolerability in different animal systems will be assessed. Certain studies must be performed in compliance with Good Laboratory Practice (GLP), which are required prior to the subsmission of the Clinical Trial Application (CTA) or Investigational New Drug (IND) application. Following general toxicity studies and clinical trial approval, further research is required to assess reproductive toxicity, chronic toxicity, carcinogenicity, and genotoxicity. These studies are performed during the clinical phase.

Non-clinical study programs are designed in accordance with general regulatory guidelines. In addition, specific drug candidates or specific indications may require tailored study designs. The non-clinical study plan should be optimized to support each phase of clinical development, from first-in-man to late-stage clinical studies and module four of the CTD of your MAA or NDA/BLA.

There are several guidelines for non-clinical testing of medicinal products that support the preparation of an application for marketing authorization. They provide insights to meeting quality, safety, and efficacy requirements of drug candidates.

Expert Support in Non-Clinical Studies

Progress has seasoned experts who are familiar with current (if applicable) GLP standards and applicable regulations and guidelines for non-clinical development. We offer expertise and services (including consultancy, project management and temporary staffing) in the field of non-clinical studies:

• Consultancy for PK/TK, safety pharmacological and toxicological studies
• GAP analysis and technical due diligence of third-party non-clinical programs, e.g., for in-licensing opportunities
• Preparing non-clinical drug development plans
• Project management of (outsourced) non-clinical development programs
• Writing non-clinical documents for regulatory submissions