Experiments performed in the laboratory and in animals to study a drug before it is tested in humans.
Studies that test a drug on animals and other nonhuman test systems. They must comply with FDA's good laboratory practices. Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies). Also, because animals have a much shorter lifespan than humans, valuable information can be gained about a drug's possible toxic effects over an animal's life cycle and on offspring.
Tests of new medical products or drugs in laboratory experiments and animal studies. These occur before experiments on humans begin.
studies that test a compound on animal or other nonhuman models, which provide data on the agent's activity and safety.
studies that test a drug on animals and nonhuman test systems. Safety information from such studies is used to support an investigational new drug application (IND).
Preclinical studies provide information about a treatment's harmful side effects and safety at different doses in animals. These studies are normally performed in animals.
Tests performed after a treatment has been shown in laboratory studies to have a desirable effect. Preclinical studies provide information about a treatment's harmful side effects and safety at different doses in animals.
studies conducted in vivo, i.e. in non-human animal models, in order to assess the efficacy and safety of gene transfer. These studies are indispensable and precede clinical trials in humans.