New Drug development and Approval Process
New Drug Development and Approval Process
Contents 1. Drug discovery and drug design 2. Biological characterization 3. Early formulation studies 4. The investigational New Drug(IND) Application(研究性新药申请) 5. The New Drug Application( NDA
Contents 1. Drug discovery and drug design 2. Biological characterization 3. Early formulation studies 4. The investigational New Drug (IND) Application(研究性新药申请） 5. 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
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 drugs sponsor(e.g a pharmaceutical company) must demonstrate, through supporting scientific evidence hat 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 at the product meets established standards
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) Preformulation 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 [-initial testing in humans Phase ll, phase lll -progressive human trials New drug application(NDA)-seeking approval t the new product
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