In pharmaceutical research (at universities but also in industrial research), a specific search for potentially suitable candidate substances for different intended uses is performed (e.g. new active ingredient, compounds, galenic forms, etc.). These substances must be tested in prescribed pre-clinical and clinical studies for quality, harmlessness and efficacy. Then the Medicines Regulatory Agency can approve their marketing.
The pre-clinical research is first and foremost concerned with searching for active ingredients and testing them.
The search for active ingredients is at the start of each innovative drug. At the same time it is important to identify a suitable control structure in a systematic, multi-level and iterative process, which can be further developed and optimised.
In order to be able to understand disease processes better, the body's own target molecules to which a drug can bind, are identified. Such targets may be receptors, transporter, enzymes or ion channels. With the interaction of the target molecules with the targets it is possible to get diagnostic information which later forms a basis for therapeutic preparation.
At the start of every pre-clinical test are different in-vitro procedures which should already give an in-depth look into the possible behaviour of the active ingredient towards the organism (pharmacokinetics and pharmacodynamics).These methods range from binding studies (affinity, selectivity and specificity, metabolism (stability) through to the information whether the pharmaceutical can reach the target at all (e.g. Blood-brain-barriers mobility).
Another important step in the pre-clinic tests (and the last step before use on humans) are the in- vivo-experiments. In this process efficacy and compliance of the substance under investigation are tested on the living organism. The behaviour of the animal organism to the pharmaceutical provides important information for the following clinical phase (human studies). These specialised trials on laboratory animals, which are necessary and prescribed (registration and approval pursuant to the valid animal protection law) call for a species-appropriate opinion but also proven expertise from the staff. The methods used range across the different diagnosis procedures (Ultrasound, µCT, µMRT, µPET und hybrid imaging).