July 08, 2016
Repeated dose toxicity studies
The main goals are to
- identify the toxicological targets,
- characterize the toxicological profile of the substance,
- define the NOAEL,
- assess the MTD,
- define the dose, plasma, or tissue levels at which toxicological effects are to be observed,
- assess the toxicokinetics,
- understand basic mechanisms of identified toxicities.
Species:
- Mammalian species including non-rodents
- In-house historical database for a wide range of rodent and non-rodent species (Mouse, Rat, Syrian Hamster, Guinea Pig, Rabbit, Beagle Dog, GöttingenMinipig)available at Aurigon
Design:
- 14 days, 28 days, 90 days or 6/9 month duration of the treatment phase
- Designs customized to test item class, test item characteristics and intended clinical use:
- Duration of recovery period after treatment phase
- Administration schedule and route
- Specific monitoring parameters (clinical observation, body weight, food/water consumption, ophthalmology, ECG, clinical pathology)
- Complete necropsy (with organ weight measurement) and histopathology (more than 42 organs and tissues)
- Control group and 3 dose groups
- Formulation analysis if necessary (see Formulation analysis of dose formulations in toxicity studies)
- TK profiling in satellite animals with either 2 or 3 profiles in rodents
- TK profiling in animals of main groups in non-rodents
- Immunotoxicity screening if required
- Standard administration routes including long term i.v. infusion available at Aurigon
- Non-standard administration routes: intranasal, intranodular, intraspinal available at Aurigon
- Special design for ATMPs, CBMPs, biologics, vaccines, medical devices
Special comments:
Outcome:
- Determination of target toxicity organs
- MTD, NOAEL
- Dose-response relationship
- Toxicokinetic evaluation
Contact: Aurigon
Phone: +49 (0)89 780 7200 10
E-Mail: info(at)aurigon.de
