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Testing Service Category: Biotech

Toxicological Risk Assessment

Understanding Risk Assessment The pathway to regulatory approval for medical products can be lengthy and expensive. Based on the FDA Biocompatibility Guidelines, it is essential to conduct your safety testing […]

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Stability Testing

Understanding Stability Testing Services Leachables studies want to follow the migration behavior of any material impurity being introduced into the drug product as a result of the interaction with the […]

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Pathology Testing Services

Understanding Pathology Testing Services Toxikon’s pathologist’s skills and expertise in comparing morphologic changes with biological phenomena puts us at the forefront of assisting sponsors in tissue assessment. These groups are […]

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Ocular Studies

Understanding Customized Ocular Studies for Targeted Therapeutics Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. Our experienced study directors will provide you with […]

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Microbiology Testing

Understanding Microbiology Testing Services Microbiological characterization of medical devices typically accompany regulatory submissions and bioburden, endotoxin, and tests for sterility are common requirements. These tests are performed according to USP […]

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Extractables & Leachables Testing

Related services USP Compendial Testing | Biocompatibility Testing | Toxicological Assessments | Chemical Characterization Understanding Extractables Extractables are compounds that migrate from the contact surface under more aggressive conditions, such as elevated temperature, […]

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Drug Safety Studies

Understanding Drug Safety Studies Drug safety studies may include pharmacokinetics, acute toxicity, repeat dose toxicity, genotoxicity, carcinogenesis, tumorigenicity, and developmental and reproductive toxicology testing. Testing Capabilities Study design Dose route […]

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Drug Development & Research

Understanding Drug Development and Research The drug development process has five distinct phases: Discovery and Development Preclinical Testing Clinical Testing Regulatory Review and Approval Post-Market Monitoring During discovery, researchers identify […]

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Chemical Characterization

Understanding Chemical Characterization Testing The purpose of this testing is to determine a baseline to the extractable amount of chemical compounds present in and on a medical device and utilize […]

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Analytical Chemistry

Understanding Analytical Chemistry Assessing the properties of a product, whether it is an unknown material or raw materials, is crucial when it comes to developing or quality- auditing a product. […]

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