Understanding Preclinical Research: The Key to Successful Innovative Drug Development
Understanding Preclinical Research: The Key to Successful Innovative Drug Development The first challenge in drug development is preclinical research of new drugs, which refers to chemical synthesis or natural product purification studies, drug analysis studies, pharmacodynamics, pharmacokinetics, toxicology, and pharmacology studies performed before a drug enters clinical studies. Preclinical studies of new medicines escort the development of innovative drugs. To New drug registration, it's vital to conduct preclinical research, including studies on the synthesis process, extraction method, physicochemical properties and purity, dosage form selection, prescription screening, preparation process, testing method, quality standard, stability, pharmacology, toxicology, animal pharmacokinetics, etc. Chinese medicine preparation also includes the original herbs' source, processing, and concoction. Biologics has quality standards, preservation conditions, genetic stability, an...