FDA Good Laboratory and Clinical Practices

Catalog description

Credits 3. 3 Lecture Hours. Implementation of Good Laboratory Practices (GLP) for the submission of preclinical studies and use of Good Clinical Practices (GCP) in clinical trials in accordance with Food and Drug Administration (FDA) regulations; includes similarities and differences in GLP and GCP critical for the introduction of new drugs and medical devices. Prerequisites: BMEN 253 ; junior or senior classification.