Preclinical Studies

A Marketing Authorization Application (MAA) for new drugs must contain all preclinical data encompassing product specification and quality, bioavailability and metabolism, toxicology and safety pharmacology as well as efficacy and pharmacodynamics. Results from preclinical testing must be provided to the regulatory agencies in order to obtain permission to initiate clinical testing in humans. Regulatory agencies review the specific tests and documentation that are required to proceed to the next stage of development.

The appropriate schedule for preclinical testing of new drugs strongly depends on the nature of the compound as well as its intended clinical use and, therefore, can therefore not be generalized. The testing strategy must be justified to the regulatory authorities.  It is best to contact the authorities prior to initiation of any study to ensure that their expectations are met.

The preclinical data must convince the authorities of the quality, safety, and efficacy of a new drug compound. Seeking advice and arrangement with the regulatory agencies about the testing program as well as designing studies in close accordance with the issued regulatory guidelines and directives is a prerequisite for any preclinical program.

You can obtain more and complete information by downloading

Recommendations for the Conduction of Preclinical Toxicological Tests for new drugs or drug compounds

To give you an overview over our activities you may download a comprehensive list of selected studies we provided for our customers.