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Good Laboratory Practices (GLPs) are standards for nonclinical research studies. These standards must be met before the research data can be accepted and reviewed by a regulatory agency. A nonclinical study involves experiments to determine the safety of a product. But not in people! Nonclinical studies are performed before they are ever tested in people. Examples might be laboratory-based research, preclinical trials using animal models, toxicology assessments, or even environmental studies. Only after the Read More…

Drug companies must follow a detailed process to build and submit their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). You can read more about NDAs in an earlier PrepRARE article here. But did you know that the FDA has its own set of rules to Read More…