山东大学：《药剂学 Pharmaceutics》课程教学资源（PPT课件讲稿，双语）02 New Drug Development and Approval Process 新药开发和批准流程

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 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

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 (ND)-for initial testing in humans Preclinical and Clinical studies Phase l-initial testing in humans Phase Il, Phase Il -progressive human Trials New drug application(NDA)-seeking approval 吗 gt 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

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

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

New Chemical Entity Molecular modification Isolation from plants eclinical Stud Biological Pharmacology ADME Toxicology -Preformulation e investigational Now Sug Applicetion (IND) FDA Revio ClinicalTrials Preclinical Studies (continued) ase 1l term animal toxicity Phase Ill Manufacturing and controls New DI n ( NDA FDA Review -Proapproval plant inspection Postmarketing tudi ies Clinical pharmacology dditional indications 尸 roduct line extension

Preclinical Clinical NDA Review Postmarketing Research and Research and development Surveillance development Initial synthesis Adverse and reaction characterization Phase 1 reporting Phase 2 Surveys/sampling Phase 3 testing Animal testing Short-term Long-term Inspections Average 62 years Average 7 years Average 12years FDA 30-day safety review NDA submitted NDA approval

1. Drug Discovery and drug Design 1 Sources of new drugs 2)A goal drug 3)Methods of drug discovery 4 )A lead compound 5)Prodrugs

1. Drug Discovery and Drug Design 1) Sources of new drugs 2) A goal drug 3) Methods of drug discovery 4) A lead compound 5) Prodrugs

1) Sources of new drugs New drugs may be discovered from a variety of natural sources or synthesized in the la boratory Plant materials have served as a reservoir of potential new drugs

1) Sources of new drugs • New drugs may be discovered from a variety of natural sources or synthesized in the laboratory. • Plant materials have served as a reservoir of potential new drugs