Overview of Drugs Approved Under the Animal Rule and Animal Efficacy Studies / 中国药学杂志

ABSTRACT

OBJECTIVE To provide reference for the industry, introduce the experimental design of animal efficacy studies and human dosage extrapolating strategy about drugs and biological products (including vaccines) approved by FDA under animal rule. METHODS This article provides an overview catalogued by the indications of drugs (including vaccines), on experimental grouping, dosage regimen, critical efficacy endpoints and other elements in the adequate and well-controlled animal efficacy studies, and further analyses the strategy of extrapolating animals efficacy data. RESULTS The regulations commonly known as the animal rule allow for the licensure of drugs and biological products developed to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substances, when human efficacy studies are not ethical and field trials to study the effectiveness of drugs or biological products are not feasible. CONCLUSION Under the animal rule, drug efficacy can be established based on adequate and well-controlled studies in animal models and the human dosing regimens can be extrapolated based on the animal data.