Pre-clinical / Non-clinical In Vivo Toxicology
Pharmacology studies such as in vivo pre-clinical 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 pre-clinical CRO in the Bay Area, GLP and non-GLP toxicology studies can encompass dosing regimens from acute (single dose) to chronic (multiple doses). Several routes of exposure (e.g., oral, intravenous, intraperitoneal, intramuscular, 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 opthalmology, clinical chemistry, hematology, urinalysis, histopathology, bioanalysis, statistical analyses and toxicokinetics.
At Pacific BioLabs, study designs are flexible and are developed to meet the specific needs of individual development programs. All testing can be conducted in compliance with applicable Good Manufacturing Practice (GMP) and 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 pre-clinical) 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.). 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 dosing 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 7 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’s Preclinical Toxicology Booklet
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