Good Laboratory Practice (GLP) Requirements for Preclinical Animal Studies

Abstract

There are persistent efforts to discover newer drugs to address huge unmet needs in the treatment of various disease conditions. The process of drug discovery and development involves both the preclinical and clinical studies which are very challenging and have huge commercial interests. Following the scientific malpractice in the pharmaceutical industries and contract research laboratories in the USA, the “good laboratory practice (GLP)” regulations were enforced in the arena of preclinical drug testing in the late 1970s. In 1981, the Organization for Economic Cooperation and Development (OECD) also developed its GLP principles which are internationally accepted. Given the public health and environmental safety concerns, various regulations and guidelines emphasize the compliance for GLP in the preclinical or nonclinical health and environmental safety studies. GLP assures the regulatory authority that the nonclinical safety data they receive from the sponsors are of high quality and accuracy that can be relied on in the risk assessment process for the product registration. The accreditation and compliance for GLP are voluntary for the test facilities and are required in the case of the regulatory submission. The present chapter covers the overview of the principles of GLP with the primary focus on requirements related to the test system in preclinical animal studies during the new drug development.