임상시험에 앞서 동물을 대상으로 한 안전성 유효성 평가를 위한 연구로 Good Laboratory Practice (GLP)에 따라 수행되어야 함.

Animal studies that support Phase I safety and tolerance studies and must comply with good laboratory practice (GLP). Data about a drug’s activities and effects in animals help establish boundaries for safe use of drug in subsequent human testing (clinical studies or trials).