In vivo testing of pharmaceutical products: Evaluation of safety and efficacy in living systems
In vivo testing of pharmaceutical products performed exclusively under laboratory conditions is not sufficient to ensure the safe and effective use of pharmaceutical products in humans. In order to understand how a product behaves in a real biological environment, in vivo tests of pharmaceutical, i.e. tests on living organisms, are required.
In vivo studies conducted under GLP (Good Laboratory Practice) ensure scientific accuracy, traceability and ethical compatibility. In our laboratory, we offer in vivo testing services in accordance with national and international regulations, in particular the OECD testing guidelines.
What are in vivo tests?
In vivo tests of pharmaceutical drugs are studies that are used to investigate the effect of drugs on a living organism (usually laboratory animals). These tests are used to determine the following properties of pharmaceutical products:
- Toxicological profile
- Pharmacokinetic properties (absorption, distribution, metabolism, excretion)
- Bioavailability and bioequivalence
- Efficacy and dose-response relationship
Safety pharmacological studies
These studies will investigate the potential negative pharmacodynamic effects of drug candidates on basic physiological systems, particularly the cardiovascular, respiratory, and central nervous systems. These studies are carried out in accordance with international standards and are based on the ICH guidelines S7A and S7B. In the preclinical phase in particular, safety pharmacology studies are carried out before the start of human trials in order to minimise risks.
Acute toxicity studies: Acute toxicity studies are carried out to determine the toxic effects of a chemical or pharmaceutical substance within a short period of time after a single exposure. These studies are conducted using different routes of administration (oral, dermal, inhaled, intravenous, etc.) to understand the dosage at which the substance can produce harmful effects.
OECD Test Guidelines 420 and 423 set international standards for oral, 402 for dermal and 403 for inhaled administration.
Repeated dose toxicity studies: Repeated dose toxicity studies are carried out to determine the potential harm that a drug or chemical substance can cause to the organism in the event of prolonged or repeated exposure. These studies will evaluate target organ toxicity, dose-response relationship, and cumulative effects. OECD guidelines 407 and 408 include oral studies, 410 dermal studies and 409 and 411 inhalation studies. These studies are usually conducted over a period of 28 or 90 days and are particularly important for determining chronic toxicity and limits for safe use.
Genotoxicity studies: Genotoxicity studies are carried out to determine whether drugs or chemicals have harmful effects on the genetic material. These tests reveal DNA damage, chromosomal abnormalities and the risk of genetic mutations. The studies are carried out both in vitro (in cell cultures) and in vivo (in living organisms).
In particular, the OECD 474 Micronucleus Test and the OECD 475 Chromosome Aberration Test are used to detect chromosomal damage in bone marrow cells.
Reproductive and developmental toxicity studies: Reproductive and developmental toxicity studies are of great importance to investigate the potential effects of newly developed drugs on reproductive capacity and embryonic/fetal development. In this context, the OECD 414 Prenatal Developmental Toxicity Study assesses the risks during pregnancy and examines the negative effects on reproductive capacity and the development of offspring over one and two generations in accordance with OECD 415 and 416 guidelines. Thanks to these studies, the safety profile of medicines in terms of fertility, embryonic development and the health of future generations can be determined in detail.
Local compatibility studies: Local tolerability studies are carried out to identify local reactions that drugs can produce at the sites of application (injection site, topical site, etc.). These studies allow the evaluation of negative local effects such as redness, edema, irritation or necrosis. These tests are mandatory in particular for parenteral, dermal or mucosally administered products and contribute to the protection of human health as well as to increasing product safety.