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