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The approval process of a vaccine is a highly regulated and systematic procedure designed to ensure that the vaccine is both safe and effective before being introduced for public use. It involves several scientific, clinical, and regulatory stages, each guided by strict protocols under the fields of anatomy, physiology, and pharmaceutical chemistry. Since vaccines interact directly with the immune system to produce protective immunity, their development must carefully consider human biological systems and chemical composition. The process begins with preclinical studies, progresses through phased clinical trials, and concludes with regulatory approval and post-marketing surveillance. The first step is preclinical testing, where the ____ __________ ____ _______ __________.
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