July 08, 2016
Single dose toxicity study / Extended single dose toxicity
The test item is administered in one or more doses during a period not exceeding 24 hours.
The aim of this study type to
- choose doses for repeat-dose toxicity studies
- provide preliminary identification of target organs of toxicity, and, occasionally, revealing delayed toxicity
- assess dose-response relationships and toxicokinetic data,
- aid the selection of starting doses for Phase 1 human studies
- provide information relevant to acute overdosing in humans.
Species:
- Mammalian species including non-rodents
- At Aurigon a in-house historical database for a wide range of rodent and non-rodent species (Mouse, Rat, Syrian Hamster, Guinea Pig, Rabbit, Beagle Dog, Göttingen Minipig) is available
Design:
Designs are customized to test item class, test item characteristics and intended clinical use:
- Intended clinical administration route
- 14 days of recovery after administration
- Specific monitoring parameters (mortalities, clinical observation, body weight, food/water consumption, ophthalmology, ECG, clinical pathology)
- Complete necropsy (with organ weight measurement) and optional histopathology (more than 42 organs and tissues)
- Formulation analysis if necessary (see Formulation analysis of dose formulations in toxicity studies)
- Optional TK profiling in satellite animals in rodents
- Optional 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, vaccines, medical devices
Special comments:
Outcome:
- Determination of target toxicity organs
- MTD, NOAEL
- Dose-response relationship
- Optional toxicokinetic evaluation
Contact: Aurigon
Phone: +49 (0)89 780 7200 10
E-Mail: info(at)aurigon.de
