In vivo Tests of Pharmaceutical Products: Assessment of Safety and Efficacy in Living Systems
In vivo tests of pharmaceuticals conducted exclusively under laboratory conditions are insufficient to ensure the safe and effective application of pharmaceutical products in humans. To comprehend how a product behaves within a real biological environment, in vivo tests of pharmaceuticals, i.e., tests on living organisms, are essential.
In-vivo studies conducted under GLP (Good Laboratory Practice) ensure scientific accuracy, traceability, and ethical compliance. In our laboratory, we offer in-vivo testing services in accordance with national and international regulations, particularly the OECD Test Guidelines.
What are in-vivo tests?
In vivo tests of pharmaceuticals are studies that investigate the effects of medicinal products on a living organism (typically laboratory animals). These tests serve 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 Pharmacology Studies
These studies investigate the potential negative pharmacodynamic effects of drug candidates on fundamental physiological systems, particularly the cardiovascular, respiratory, and central nervous systems. These studies are conducted in accordance with international standards and are based on ICH Guidelines S7A and S7B. Specifically, in the preclinical phase, safety pharmacology studies are performed before human trials commence to minimize risks.
Acute Toxicity Studies: Acute toxicity studies are conducted to determine the toxic effects of a chemical or pharmaceutical substance after a single exposure within a short period. These studies are performed using various routes of administration (oral, dermal, inhalation, intravenous, etc.) to understand at what dosage the substance can induce harmful effects.
OECD Test Guidelines 420 and 423 establish international standards for oral administration, 402 for dermal, and 403 for inhalation administration.
Repeated Dose Toxicity Studies: Repeated dose toxicity studies are conducted to identify the potential harm that a drug or chemical substance may cause in an organism upon prolonged or repeated exposure. These studies assess target organ toxicity, dose-response relationships, and cumulative effects. OECD Guidelines 407 and 408 cover oral administration studies, 410 for dermal, and 409 and 411 for inhalation administration. These studies are typically conducted over a period of 28 or 90 days and are particularly important for determining chronic toxicity and safe use limits.
Genotoxicity Studies: Genotoxicity studies are conducted to determine whether drugs or chemical substances have harmful effects on genetic material. These tests reveal DNA damage, chromosomal aberrations, and the risk of genetic mutations. The studies are performed both in vitro (in cell cultures) and in vivo (in living organisms).
Specifically, the OECD 474 Micronucleus Test and the OECD 475 Chromosomal 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 for investigating 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 risks during pregnancy, and in accordance with OECD 415 and 416 guidelines, the adverse effects on reproductive capacity and offspring development over one and two generations are investigated. Thanks to these studies, the safety profile of drugs regarding fertility, embryonic development, and the health of future generations can be determined in detail.
Local Tolerance Studies: Local tolerance studies are conducted to identify local reactions that medicinal products may cause at application sites (injection site, topical application site, etc.). These studies allow for the assessment of adverse local effects such as erythema, edema, irritation, or necrosis. These tests are particularly mandatory for parenterally, dermally, or mucosally administered products and contribute both to the protection of human health and to enhancing product safety.