Preclinical Toxicological Studies in Pharmacological Products

Preclinical Safety Assessment of Pharmacological Products

Preclinical Toxicological Studies in Pharmacological Products: Safety Assessment

Preclinical toxicology studies aim to determine the potential toxic effects of a drug or vaccine, which organs it targets, dose dependency, and whether the effects are reversible. Additionally, they investigate whether the drug or vaccine candidate affects genetic material and increases the risk of cancer. These studies are classified based on exposure duration (acute, subacute, subchronic, and chronic) and conducted using animal models. International Conference on Harmonization (ICH) guidelines, particularly ICH M3(R2), aim to standardize the design, conduct, and reporting of these studies. This provides a solid foundation for safety before human clinical trials begin.

Preclinical Safety Evaluation of Pharmacological Products

Pharmaceutical products such as drugs and vaccines are of great importance for human health. However, their safety and efficacy must be rigorously evaluated before they are marketed. An important part of this evaluation process is preclinical toxicology studies. OECD GLP (Good Laboratory Practice) principles ensure that these studies are conducted in a reliable and standardized manner. Preclinical toxicology studies are conducted to identify the potential toxic effects of a drug or vaccine and to assess its suitability for use in humans. These studies are performed using animal models and are classified according to different exposure times. Additionally, the International Conference on Harmonization (ICH) guidelines aim to harmonize regulatory expectations for preclinical studies.

What Information Can Be Obtained from Preclinical Toxicology Studies?

Preclinical toxicology studies evaluate a drug or vaccine for:

• Acute (single dose): Evaluates the effects of a single dose.
• Subacute (14-28 days): Examines the effects of short-term repeated doses.
• Subchronic (90 days): Investigates the effects of repeated doses over a medium-term period.
• Chronic (180 days, rodents; 270 days, non-rodents): Evaluates the effects of repeated doses over a long-term period.

These studies help determine factors such as the toxic effects that a drug or vaccine may cause, target organs, dose dependency, and potential reversibility. The data obtained are used to establish a safe starting dose and dose range for human trials, monitor potential side effects, and inform the labeling of the drug. It evaluates the potential toxic effects of the vaccine or drug, its effects on reproduction and development, whether it causes changes in genetic material, and its cancer risk. In the drug development process, preclinical toxicology studies provide information about the safety of a new drug candidate. These studies are generally required by regulatory agencies worldwide. The ICH M3(R2) guideline addresses the design, conduct, and reporting of non-clinical safety studies. This guideline provides guidance on which studies should be conducted before initiating human clinical trials, study durations, animal models, and evaluation criteria.

As Nanolab Laboratories Group, we are a GLP-compliant laboratory specializing in basic toxicology testing. Our current focus areas include:

• Acute toxicity tests
• Subacute toxicity tests
• Subchronic toxicity tests
• Chronic toxicity tests

Additionally, we evaluate requests for specific toxicology studies such as genotoxicity and carcinogenicity and offer customized solutions. If you are seeking a reliable partner for your drug development process,

Nanolab Laboratories Group, as a GLP-certified laboratory, conducts preclinical toxicology studies for your pharmaceutical products in accordance with OECD GLP principles. We provide services with our expert team and state-of-the-art equipment to ensure reliable and accurate results. We are here to support you in your drug and vaccine development process and ensure the safety of your products.