ABSTRACT
Toxicology and safety assessment studies conducted in support of a regulatory submissions for pharmaceuticals, food and feed ingredients, medical devices, pesticides, tobacco products, chemicals, and some consumer products may follow many regulations and guidelines to be acceptable to regulatory bodies. This chapter focuses on the needs of the United States Food and Drug Administration. All laboratory personnel must have a safe working environment and must be educated of the potential hazards associated with their jobs. Most of the studies that are performed for nonclinical toxicology assessments have little or no history of safety in humans. Therefore, precautions need to be taken to limit or eliminate the exposure to the chemicals. Drugs evaluated for efficacy under the Animal Rule should be evaluated for safety under the existing requirements for establishing the safety of new drugs. Animals need to be taken care of, including being provided with fresh food and water, shelter, environmental enrichment, and veterinary care when needed.
