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Many nonclinical and clinical studies are conducted to submit new drug applications for chemical entities. Nonclinical studies cover pharmacology, pharmacokinetic, and toxicology aspects and provide pharmacologic evidence as well as kinetic and toxicologic profiles of the compounds. The risks and benefits of compounds are evaluated based on these nonclinical studies, especially before initiation of the first human trials. Therefore, using adequate procedures, highly controlled, quality nonclinical data should be obtained. This section shares and discusses items required of good laboratory practice (GLP)-compliant organizations and management systems in GLP facilities in the pharmaceutical industry as well as those required for GLP inspections by the Japanese Pharmaceuticals and Medical Devices Agency. In addition, it explains standard operating procedures for conducting quality, non-GLP, pharmacology, and pharmacokinetic studies.

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Conducting Assured Nonclinical Studies in the Pharmaceutical Industry: Good Laboratory Practice (GLP) Study, GLP Inspection, and Standards for Assurance