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IN VIVO PHARMACOLOGY: TOXICOLOGY STUDIES

Preclinical / Nonclinical In Vivo Toxicology

Pharmacology studies such as In vivo toxicology studies are intended to assess the onset, severity, and duration of toxic effects, their dose dependency and degree of reversibility (or irreversibility). At Pacific BioLabs, a preclinical research CRO, GLP toxicology studies can encompass dosing regimens from acute (single dose) to chronic (multiple doses). Several routes of exposure (e.g., oral, intravenous, intramuscular, topical, etc) can be accommodated and multiple species (e.g., rodents, rabbits, guinea pigs and dogs) are available. A full complement of toxicology evaluations is available, either through in-house resources or through strategic partnerships with external vendors. These evaluations include clinical chemistry, hematology, urinalysis, histopathology, ophthalmology, bioanalysis and toxicokinetics.

At Pacific BioLabs, study designs are flexible and are developed to meet the specific needs of individual development programs. All testing complies with applicable Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations as needed. Our animal facility is AAALAC accredited and USDA and OLAW compliant.

Purpose of GLP Toxicology Studies

Nonclincal (or preclinical) toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans, and to extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.). Nonclinical studies may be conducted in a nonGLP fashion for preliminary investigations; however, it is expected that studies used for direct extrapolation to human safety will be conducted according to GLP. Nonclinical toxicology studies vary in length (e.g., acute, subchronic, chronic) depending on the length of dosing in the clinical trial they are supporting and the stage of development of the test article (IND, NDA, BLA, etc). The reader is directed to the ICH M3(R2) guidance for information on the scope of the nonclinical support expected at various stages of drug development:

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

In vivo toxicology studies are also required to establish the toxicological profiles of materials that may pose a significant human health risk via environmental exposure. These studies may be conducted in a nonGLP fashion for preliminary investigations; however, it is expected that studies used for direct extrapolation to human safety will be conducted according to GLP. The reader is directed to the EPA guidance website for information on the conduct of these studies:

http://www.epa.gov/lawsregs/policy/sgd/bytopic.html

Want to learn more about preclinical toxicology? Visit our Learning Center section on the drug development process.

Test Categories

  • Acute Toxicity
  • Subacute Toxicity
  • Subchronic Toxicity

Available species

  • Mouse
  • Rat
  • Rabbit
  • Guinea Pig
  • Dog

Routes of administration

  • Oral
  • Intravenous
  • Intraperitoneal
  • Topical
 
 
 
Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.
   
   

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