Preclinical Toxicology Studies

Bio-Quant's state-of-the-art facility specializes in contract performance of toxicology studies. Non-GLP toxicology studies are intended to provide preliminary assessment of a drug's safety. GLP toxicology studies are required as a prerequisite for filing an IND package, prior to Phase I clinical trials.

Non-GLP toxicology studies can be performed on research grade materials to reduce costs and promote study design flexibility. These early stage studies can be performed prior to committing to the substantial costs in time and financial resources required to producing GMP grade material.

GLP toxicology studies are required as part of the IND package and are normally performed only on GMP produced material. GLP-compliant regulatory tests are mandated for marketing approval.


In Vivo Cardiocytotixicity Screen™

In the past few years, much attention has been focused on drugs that prolong the QT interval, potentially leading to malignant cardiac rhythm disturbances, such as torsade de pointes. Several drugs were withdrawn from the market (e.g., terfenadine, astemizole, cisapride, and grepafloxacin) because they either directly caused electrocardiographic abnormality or resulted in drug-drug interactions that led to unacceptable rates of cardiotoxicity. Hence, the need to assess the cardio-safety of drugs at an early stage of development.

Services Offered:

Bio-Quant is the only CRO on the west coast that offer non invasive surface telemetry in freely roaming dogs that assess:

  •    ECG, QT prolongation, Heart rate
       Animal activity
       Temperature

Bio-Quant surface telemetry allows the recording of the animals sign continuously for up to 72 hours without interruption.

In addition to the direct heart function monitoring, we offer a cardiac blood panel to quantify the levels of:

  •    LDH
       SGOT
       CPK
       Myoglobin
       Troponin I
       C-reactive protein

Toxicology Study Types

  •    Maximum tolerated dose (MTD)
       Subchronic Toxicity
       Single dose range-finding and acute toxicity studies
       Repeated Dose
       Sensitization
       Irritation

Routes of Administration

All standard routes of administration are offered. Our strength is accommodating specialized client needs for treatment regimens.

  •    Subcutaneous
       Intraperitoneal
       Intravenous
       Intramuscular
       Topical
       Oral
       Controlled release pumps

Species

Bio-Quant offers all standard test species.
The following species can be housed at Bio-Quant 's vivarium.

  •    Mouse
       Rat
       Hamster
       Guinea Pig
       Rabbit
       Dogs
       Gerbils
       Pig (Mini, Micro, Domestic)
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