IntroductiontoDrugsandPharmacy.ppt

New Drug Development and Approval Process Contents Drug discovery and drug design Biological characterization Early formulation studies The investigational New Drug (IND) Application(研究性新药申请） The New Drug Application (NDA) The Federal Food, Drug, and Cosmetic Act,as regulated through Title 21 of the U.S. Code of Federal Regulations, requires a new drug to be approved by the Food and Drug Administration(FDA) before it may be legally introduced in interstate commerce To gain approval for marketing, a drug’s sponsor (e.g., a pharmaceutical company) must demonstrate, through supporting scientific evidence, that the new drug or drug product is safe and effective for its proposed use. The sponsor must also demonstrate that the various processes and controls used in producing the drug substance and in manufacturing, packaging, and labeling are properly controlled and validated to ensure that the product meets established standards The process and time course from drug discovery to approval for marketing can be divided into following process: New Chemical Entity (synthesis) Prefomulation studies-define the physical and chemical properties Formulation studies-develop the initial features of the proposed pharmaceutical product or dosage form Investigational new drug application(IND)-for initial testing in humans Preclinical and Clinical studies Phase I-initial testing in humans Phase II, Phase III -progressive humanTrials New drug application (NDA)-seeking approval to market the new product. Content of a product’s approved labeling-essential chemistry, pharmacology, toxicology, indications and contraindication for use, adverse effects, formulation composition, dosage, and storage requirements. Treatment IND, Orphan drug Supplemental new drug application (SNDA) Abbreviated new drug application(简化新药申请) to gain approved to market a duplicate Antibiotic drug; biologics; Medical devices 1. Drug Discovery and Drug Design Sources of new dru