Toxicological Risk Assessment

Non-clinical safety studies on candidate drugs are needed to be performed during the development of new pharmaceutical products. Typically these safety studies involve the assessment of general toxicology, safety pharmacology and genetic toxicity test batteries. Drug toxicology is to study the toxic reactions and toxic effects caused by the various harmful substances in drug. The toxicology assessment of drugs is equally important as efficacy assessment, as they both are related to the health of patients. The toxicity of substances used in products is a primary concern to today's customers, they require reassurance that products will not damage their health. Nowadays, more and more companies have focused on the toxicological issues and assessment of potential hazard, to ensure product quality, brand integrity, a business's position in the marketplace and economic profit.

Toxicological Risk Assessment (TRA) is to assess the toxicological characterization of each component in drug product like API, leachable impurities, contaminants, or other residues, and to evaluate the potential health risks associated with the exposure of product in the actual use process. The risk assessment is also to make a determination regarding whether the release of chemicals during the use of drug may show a toxicological risk that is unacceptable from a regulatory perspective. Through performing TRA, you can determine if the product is safe for its intended use or if any product changes or further evaluations are needed. TRA is regarded as an alternative to animal testing, and has the advantages of high efficiency and low cost.

Toxicological risk assessment of pharmaceuticals is a highly specialized process. Alfa Chemistry has professional knowledge in pharmaceutical toxicology, and has evaluated over hundreds of thousands products involving prescription medications, drugs of abuse, vaccines. Our team of experienced toxicology professionals can conduct high quality toxicological risk assessments. By performing the most appropriate assessments and tests, we can ensure your products are safe enough to help maintain your brand integrity and achieve their best in the marketplace. Our services involve the toxicological assessment of the actives (and their metabolites), excipients, impurities, contaminants, degradants and extractables/leachables.

Our Toxicology Risk Assessment (TRA) Services include:

• Actives- hazard assessments of active substances for due diligence purposes and marketing authorisation applications;

• Excipients- hazard and health risk assessment of substances with a specific technological function included in pharmaceutical products;

• Impurities/Contaminants/Degradants- health risk assessment of substances inducted during product manufacture and/or storage; 

• Extractables/Leachables- health risk assessment of substances (contaminating pharmaceutical products) leaching from processing equipment or containers/closures during production, storage or use.

TRA is a research-based evaluation, based on a substance chemical characterization, published information from the toxicological literature and tolerable exposure limits. It can be used from published guidelines or derived from existing toxicological data. The methods for toxicological risk assessment are described in some Regulatory Guidance.

• ISO 10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process

• ISO 10993-17: Biological Evaluation of Medical Devices-Part 17: Establishment of Allowable Limits for Leachable Substances

• ICH M7. 2015: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, Guidance for Industry

For more information about our toxicological risk assessment services, please contact us.