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SAFETY TESTS

The General  Safety Tests are primarily utilized in the testing of biological products intended for direct administration to humans or animals.  These tests are conducted for the detection of non-specific, extraneous toxic contaminants that may be present in the final filling of each lot of licensed product, such as antitoxins, antivenins, blood, blood derivatives, immune serums, immunologic diagnostic aids, toxoids, or vaccines.

These methods may also be applied to the testing of individual device types or materials as recommended by an appropriate testing guidance, monograph or regulatory body.

Generally, these tests are short duration, single application tests to evaluate overt toxicity.  A defined amount of material is introduced into the test system and subsequently evaluated over a few days for gross evidence of toxicity, such as survival and/or body weight loss. 

General Safety Tests

  • CFR Safety Test (for Biologics)
  • JP Systemic Test
  • USP Systemic Injection Tests
  • Abnormal Toxicity Test (for vaccines/immunosera)
  • USP Iron Dextran

 
 
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