An extensive overview of drug safety evaluation and the pharmaceutical development process, beginning with the historical role of synthetic chemistry in drug discovery, followed by the continuing importance of natural products. It thoroughly details the regulatory landscape in the United States, including the role of the FDA and key legislation like the FD&C Act and the Kefauver-Harris Amendment, which established requirements for safety and efficacy testing through Investigational New Drug Applications (INDAs) and New Drug Applications (NDAs). A significant portion of the text addresses the nonclinical safety assessment of drugs, covering topics such as genotoxicity, immunotoxicity, developmental and reproductive toxicity, and carcinogenicity studies, frequently referencing ICH guidelines and the use of various animal models (rodent and nonrodent species). Finally, the source touches upon the challenges and procedures in clinical trials, including adverse drug reaction (ADR) reporting and the evolving role of in vitro techniques in toxicology assessment.
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