Preclinical Studies

Preclinical studies are an indispensable component of drug development. Before an active substance can be tested in humans, its safety, efficacy, and tolerability must be evaluated under laboratory conditions. These studies provide crucial data for the approval and further development of pharmaceutical products.

The preclinical testing procedures encompass a broad spectrum of analytical and biological investigations.

Pharmacodynamic Test Methods

To determine the biological effect of an active substance, we conduct a variety of pharmacodynamic tests, including:

• Receptor Binding Assays, which investigate the selectivity and strength with which an active substance binds to its target receptors.
• Enzyme Inhibition Assays, to measure whether and to what extent an active substance blocks enzymes – crucial for, e.g., anti-inflammatory or antimicrobial substances.
• Immunological Response Tests, which assess the potential stimulation or suppression of the immune system (e.g., cytokine release, antibody formation).

Pharmacokinetic Studies (ADME)

In this phase, we analyze the absorption, distribution, metabolism, and excretion of the active substance within the body. The results aid in determining the correct dosage, avoiding interactions, and estimating the duration of a drug's effect.

Analyses of Pharmaceutical Water

For the manufacturing and analysis of pharmaceutical products, the quality of the water used is essential. Our laboratories offer the following water analyses in accordance with Ph. Eur.:

• Purified Water (Aqua purificata) – Ph. Eur. 04/2018:0008
• Water for Extract Preparation – Ph. Eur. 04/2012:2249
• Water for Injections (Aqua ad iniectabilia) – Ph. Eur. 04/2017:0169

Our Process

Our preclinical studies are conducted in compliance with international guidelines such as ICH, OECD, and GLP. We offer comprehensive analytical support in the following areas:

• Pharmacodynamic Tests: Receptor binding, enzyme inhibition, immunological response
• Pharmacokinetic Studies: ADME profiles and biological half-life
• Water Analysis according to European Pharmacopoeia Standards
• Toxicological Pre-investigations for Clinical Phases
• Our expertise ensures that your product transitions into the next development phase with scientific rigor and regulatory compliance.