Regulatory Objectives

In order to help ensure the safety and efficacy of human pharmaceuticals, pharmacologists and toxicologists evaluate results of drug testing in animals (in vivo) and culture systems (in vitro).  They relate the effects observed nonclinically (i.e. in animals) to potential pharmacologic and toxicologic effects in humans.   There are several types of nonclinical studies in Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submitted to the Center for Drug Evaluation and Research (CDER) to support drug use in humans.  These include: 

• Studies on the pharmacological actions of the drug in relation to its proposed therapeutic indication; 

• Studies that define the pharmacologic properties of the drug or are pertinent to possible adverse effects; 

• Studies on the toxicological effects of the drug as they relate to the drug's intended clinical uses, including studies assessing the drug's acute, subacute, and chronic toxicity, and carcinogenicity.  Studies of toxicities related to the drug's particular mode of administration or conditions of use;

• Studies of the effects of the drug on reproduction and on developing fetuses;

• Studies of the absorption, distribution, metabolism, and excretion of the drug in animals.

This site contains our current recommendations on the conduct and submission of nonclinical data to support the safety and efficacy of drugs for human use, as well as additional relevant information.  

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FDA/Center for Drug Evaluation and Research
Last Updated: January 14, 2004
Originator: OTCOM/DLIS
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