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Testing Service Category: Combination

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 within a risk management context; this may be advantageous in reducing your time-to-market without compromising on safety. The right consulting partner can help you evaluate […]

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Surgical Research

Uniquely Equipped to Assist in the Development of Tomorrow’s Lifesaving Medical Devices and Drugs Toxikon’s Department of Efficacy and Surgical Research Services is uniquely equipped to assist in the development of tomorrow’s lifesaving medical devices and drugs. Our experts are well-versed in comparative medicine as well as special surgical approaches, delivery methods, various imaging modalities, […]

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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 materials of construct during the intended use. The conditions of “intended use” for leachable studies often refer to the storage conditions, selected for the stability […]

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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 responsible for establishing criteria for the interpretation for a wide variety of studies and animal models. We are dedicated to providing sound research programs that […]

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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 the expertise in ophthalmology models and endpoints for your ocular drug and device programs. Ophthalmic drug discovery Ophthalmic device and implantation Ophthalmic safety and toxicity […]

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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 and AAMI guidance. Combination devices that contain antimicrobial agents or antibiotics require evidence that the device possesses antimicrobial properties under simulated use and worst-case testing […]

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Medical Device Cleaning Validation

Validating the Efficacy of SOPs and IFUs for Reusable Medical Devices Medical devices in this category must have adequate labeling and directions for use (21 CFR Part 801) related to the Instructions for Use (IFU) and reprocessing. These studies apply worst-case challenge conditions and are required to ensure a reusable device is appropriately prepared in […]

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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, extended contact time, or aggressive solvent system. Any component that is added to or pulled from the device or the materials used to make the […]

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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 determination Clinical pathology evaluation Necropsy Histology Pathology / histopathology Testing Categories Pharmacokinetic Studies Single Dose Pharmacokinetic Study in Rodent Models Single Dose Pharmacokinetic Study in […]

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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 a new drug candidate that shows promise through research, experimentation, or sometimes accident. Thousands of compounds may be considered; only a select number may show […]

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