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 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 Several drugs were withdrawn from the market (e.g., terfenadine, astemizole, cisapride, and grepafloxacin) because they either directly caused electrocardiographic abnormality or resulted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
- Maximum tolerated dose (MTD)
- Acute Toxicity
- Subchronic Toxicity
- Single dose range-finding and acute toxicity studies
- Repeated Dose
- Sensitization
- Irritation
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
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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)
