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Toxicology
Absorption Systems has added toxicology to our ADME capabilities.
Absorption Systems offers a full spectrum of IND- and NDA-enabling non-GLP and GLP toxicology studies conducted in our AAALAC-accredited facility in San Diego. Combined with our already extensive portfolio of preclinical in vitro and in vivo ADME services and GLP bioanalysis, the addition of toxicology means that Absorption Systems provides everything necessary to advance a compound to the IND stage. Furthermore, longer-term drug safety studies support NDA submissions.
Board-certified toxicologists, veterinarians, and experienced technicians are on staff, supported by formulation development and GLP bioanalysis of toxicokinetic samples, for in-depth investigation of drug safety.
According to Thomas Darcy, Executive VP and CFO of Tocagen, “Absorption Systems performed our GLP toxicology study in a highly professional and efficient manner. Moreover, we were very impressed with how quickly they mobilized their staff during the holiday season to help us respond to a new FDA request, thereby avoiding a possible significant regulatory delay.”
Wide range of toxicology study types:
- Maximum tolerated dose (MTD)
- Acute, subchronic, chronic toxicology
- Dose range finding
- Repeated dose
- Sensitization
- Irritancy
- Dermal
- Mouse
- Rat
- Guinea pig
- Hamster
- Rabbit
- Ferret
- Dog
- Goat
- Mini-pig
- Pig
- Sheep
- Oral gavage
- Capsule
- Dietary admixture
- Dermal
- Intravenous
- Subcutaneous
- Intradermal
- Intramuscular
Related Literature
This study design is used to determine the maximum tolerated dose (a dose that does not produce mortality or overt clinical signs of toxicity) of a test article in male and female rats after single and repeat dosing (non-GLP).
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This GLP study design is used to determine the toxicity of a test article in male and female rats after repeat dosing for 14 days followed by a 7 day recovery period.
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This study design is used to determine the maximum tolerated dose (a dose that does not produce mortality, more than a 10% decrease in body weight or overt clinical signs of toxicity) of a test article in male and female dogs after single and repeat dosing (non-GLP).
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Brochures
The general toxicology services offered at our AAALAC-accredited facility
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