Preclinical / Nonclinical In Vivo Toxicology

Pharmacology studies such as In vivo preclinical 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 in the Bay Area, 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 and guinea pigs) 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. IND enabling studies 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:

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.

In Vivo Toxicology Test Categories

  • Acute Toxicity
  • Subacute Toxicity
  • Subchronic Toxicity
  • IND Enabling Studies
  • Dose Escalation Studies

Available Species

  • Mouse
  • Rat
  • Rabbit
  • Guinea Pig

In Vivo Toxicology Routes of Administration

  • Oral
  • Subcutaneous
  • Intravenous
  • Intramuscular
  • Intraperitoneal
  • Topical

Read More About In Vivo Preclinical Toxicology

FDA Biomarker Qualification Program

PBL Learning Center – Stages of Drug Development

PBL Learning Center – Preclinical Tests Timeline

PBL’s Preclinical Toxicology Booklet
Download the free booklet

 

Scroll Up