Comprehensive Toxicology Services
From Discovery / Non-Clinical - Strategy and Consulting
Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data into the right context of patient exposure (dose) it informs whether patient safety is unlikely to be compromised and therefore the likelihood of regulatory acceptance. This is the foundation of toxicological risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualifications and experience.
Be it a drug, medical device, cosmetic, consumer p...
Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market. We achieve this by fully leveraging the data existing in the literature by way of a comprehensive literature search that covers a wide variety of medical and toxicological databases. When the available data is inadequate, we apply computational toxicology or quantitative structure-activity (QSAR) tools (also called in silico tools), and by fully leveraging the data available for structurally and pharmacologically similar chemical (read-across approach). New experiments are recommended only when it is absolutely necessary. When we design those studies, we follow the ‘lean study design’ concept that gives maximum safety/toxicity information and we keep the end in mind such that they generated data is useful in addressing the issue at hand. This helps our clients save money and time and is in line with the 3R principles of animal welfare (Reduction, Replacement, and Refinement). All through the process, we keep the regulatory expectations in mind so that the assessment reports are accepted in the first place without having to answer follow-up regulatory queries.
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