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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 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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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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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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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 extraction conditions similar to those utilized in biocompatibility determination of similar devices. Chemical Characterization Techniques Gas Chromatography/Mass Spectrometry (GC/MS): Analyzes the extract samples for Volatile […]

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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. To help ensure product quality, consistency and safety, we offer a comprehensive range of analytical chemistry testing services. Analytical Chemistry Services Method development and validation […]

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