During (early) drug development non-clinical studies (often also referred to as pre-clinical studies) are performed to assess the safety and efficacy of drug candidates. The objective of these studies is to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties for dosing strategies and toxicity (incl. geno-, repro-, and immunotoxicity) and toxicokinetics (TK).
Non-clinical study programs are designed in accordance with general regulatory guidelines. In addition, specific drug candidates or specific indications may require tailor-made study designs. The non-clinical study plan must be optimized to support each phase of clinical development, from first-in-man to late stage clinical studies and module 4 of the CTD of your MAA or NDA/BLA.
Progress-PME provides expertise and services in the field of non-clinical studies:
- Consultancy for PK/TK, safety pharmacology and toxicology studies
- GAP analyses and technical due diligences 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 of non-clinical documents for regulatory submissions