Pre-clinical / Non-clinical In Vivo Toxicology
Pharmacology studies such as in vivo preclinical toxicology studies are intended to assess the onset, severity, and duration of toxic effects, dose-dependency, and degree of reversibility (or irreversibility).
At Pacific BioLabs, a preclinical CRO in the Bay Area, GLP, and non-GLP toxicology studies can encompass dosing regimens from acute to chronic (single or repeat dose). Several routes of exposure (e.g., oral, intravenous, intraperitoneal, intramuscular, subcutaneous, topical, etc.) can be accommodated, and multiple species (e.g., rats, mice, rabbits, guinea pigs, and hamsters) 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 ophthalmology, clinical chemistry, hematology, urinalysis, histopathology, bioanalysis, statistical analyses, and toxicokinetics.
At Pacific BioLabs, study designs are flexible and developed to meet individual development programs’ specific needs. All testing can be conducted in compliance with applicable Good Laboratory Practice (GLP) regulations or non-regulatory as needed. Our animal facility is AAALAC accredited and USDA and OLAW compliant.
Purpose of GLP Toxicology Studies
Non-clinical (or preclinical) toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans and extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.). Non-clinical studies may be conducted in a non-GLP fashion for preliminary investigations; however, it is expected that studies used for direct extrapolation to human safety will be conducted according to GLP.
Non-clinical toxicology studies vary in length (e.g., acute, subchronic, chronic) depending on the length of exposure in the clinical trial they are supporting and the stage of development of the test article (IND, NDA, BLA, PMA, etc.). The reader is directed to the ICH M3(R2) guidance for information on the scope of the non-clinical 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 non-GLP 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 Systemic Toxicity (3 to 14 days)
- Subacute Toxicity (14 to 30 days)
- Subchronic Toxicity (longer than 30 days)
- IND Enabling Studies
- Dose Escalation Studies
- Guinea Pig
In Vivo Toxicology Routes of Administration
Read More About In Vivo Pre-clinical Toxicology
- PBL Clients in the News – Targeting Toxins in Snake Venom
- 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