Antibody and Protein Toxicology

Pre-clinical toxicology is a study of the toxic effects of drugs in development based on statistical and quantitative analysis. Our antibody and protein toxicology service portfolio provides you with a complete workflow to reduce the risk of your early drug discovery or later development programs.

At Creative Biolabs, toxicological studies are available in rodent and non-rodent species in accordance with national and international guidelines, including:

For the above toxicology studies, we perform diverse testings to address clients needs' including acute, subchronic, and chronic toxicity tests. The length of the study (e.g., acute, subchronic, chronic) varies depending on the length of administration in the clinical trials it supports and the stage of development of the test article (IND, NDA, BLA, etc.).

  • Acute toxicological studies focus on the toxicological effects of a single large dose of the target substance.
  • Subchronic toxicological studies include repeated small doses of test substance over a period of up to 90 days.
  • Chronic toxicology research focuses on the long-term effects of test substances.

Toxicological Studies Capabilities

Acute Toxicity

  • To determine the median lethal dose (LD50) after a single dose is administered by one or more routes, one of which is the intended route of administration for humans.
  • To determine the maximum tolerated dose (MTD) and no observable level.
  • To identify potential toxic target organs and determine reversibility of toxicity and parameters for clinical monitoring.

Sub-Chronic Toxicity

  • To establish an "unobservable level of influence" (NOEL).
  • To characterize the dose-response relationship after repeated doses.
  • To identify and characterize specific organs affected after repeated dosing.
  • To help select the dose for repeated dose toxicity testing.

Chronic Toxicity

  • To characterize the dose-response relationship after repeated administration.
  • To identify and characterize specific organs affected after repeated dosing.
  • To assess the cumulative toxicity of chemicals.
  • To assess the possibility of carcinogenesis.

Reproductive Toxicity

To determine the potential adverse effects of test materials on mammalian gametogenesis, fetal organogenesis, childbirth, lactation, neonatal survival, vitality and development.

Additional Details

Type of Sample

  • Small molecules
  • Biologics
  • Antibody and Protein
  • Vaccines

Species

  • Rodents
  • Canines
  • NHPs
  • Swine

Routes of Administration

  • Oral
  • Subcutaneous
  • Intraperitoneal
  • Intramuscular
  • Intravenous

Pathological Capabilities

  • Pathological Capabilities
  • Clinical pathology
  • Histology
  • Immuno- histopathology
  • others

Feel free to contact us for project quotations and more detailed information.

For lab research only, cannot be used for any clinical use.

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