{"id":3324,"date":"2021-07-16T05:42:29","date_gmt":"2021-07-16T05:42:29","guid":{"rendered":"http:\/\/deepfda.com\/?page_id=3324"},"modified":"2024-11-11T22:17:53","modified_gmt":"2024-11-11T22:17:53","slug":"%e6%af%92%e7%90%86%e5%ad%a6%e7%a0%94%e7%a9%b6","status":"publish","type":"page","link":"https:\/\/deepfda.com\/us\/%e6%af%92%e7%90%86%e5%ad%a6%e7%a0%94%e7%a9%b6\/","title":{"rendered":"Toxicology Research"},"content":{"rendered":"

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Toxicology Studies<\/span><\/span><\/h2>
We provide compliant toxicology studies to support candidate drugs in meeting regulatory agency requirements<\/div><\/header>
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Data on in vitro metabolism and plasma protein binding in animals and humans, as well as repeated-dose toxicity study data (ICH S3A), should typically be evaluated before initiating human clinical trials. Before exposing a large number of human subjects or conducting long-term treatments (usually prior to Phase I), more information regarding the pharmacokinetics (PK) of the test species (such as absorption, distribution, metabolism, and excretion) should be obtained, along with in vitro biochemical information related to potential drug interactions. This data can be used to compare metabolites between humans and animals and to determine whether any additional testing is necessary.<\/p>\n

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We provide acute and chronic toxicity study services, including:<\/p>\n

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  • Respiratory Rate, Tidal Volume, and Minute Volume.<\/li>\n
  • Maximum Tolerated Dose (MTD)<\/li>\n
  • Dose Range Finding Study (DRF)<\/li>\n
  • Acute, Subchronic, and Chronic Toxicity Studies<\/li>\n
  • Repeated Dose Toxicity Studies<\/li>\n
  • Reproductive Toxicology<\/li>\n
  • Carcinogenicity Studies<\/li>\n
  • 2-Year and 6-Month Transgenic Studies<\/li>\n<\/ul>\n

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    Biosafety Level 3 (BSL-3) and Safety Pharmacology Studies<\/span>Under Biosafety Level 3 (BSL-3) conditions

    \nSafety Pharmacology Studies<\/span><\/span><\/h3>
    Provide emergency priority access to candidate drug services in a biosafety level laboratory. <\/div><\/header>
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    Conduct research and efficacy testing of Medical Countermeasures (MCM) for biological and chemical defense in collaboration with global partners. This includes the use of all exposure routes for preventive, therapeutic, and diagnostic products in both large and small models. Utilize BSL-3 (P3) resources to complete toxicology studies for preventive, therapeutic, and diagnostic products.<\/p>\n

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    Biosafety Laboratory<\/span><\/span><\/h3>
    Collaboration with Biosafety BSL-2 (P2) and BSL-3 (P3) laboratories to provide GLP-compliant efficacy studies and ABSL-3+ (P3+) animal biosafety experimental services.<\/div><\/header>
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    Research Testing for Clinical Trials<\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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    Validation and Beta Testing<\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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    Safety Advisory Services<\/span><\/span><\/h5><\/header><\/div><\/div><\/div><\/div>
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    Contact Us<\/span>Access More Service Information<\/span><\/span><\/h3><\/header>
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