Mammalian Toxicity

RDDT Toxicity Studies determine:

• the dose (exposure) which produces toxic effects in animals
• the dose (exposure) that does not produce toxic effects in animals
• the relevant animals models for predicting human toxicity?
• the signs and duration of toxic responses
• the differences in toxicities following single or multiple dosing
• if the toxic responses are reversible in a satellite group which undergo a drug-free recovery period
• the target organs or systems affected
• if the toxicity is expected for the chemical class
• if toxic metabolites are produced
• the plasma drug levels in the toxicology studies (toxicokinetic analysis)
• if adaptation to the toxic effects are observed.

Guidelines

Studies are performed to:

• Guidelines of the International Conference for Harmonization (ICH)
• National Guidelines, such as those of the USA (FDA) or EU (CPMP)
• OECD Chemical Testing Guidelines.