Content of a products approved labeling-essentia 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
Now Chemical Entity Organic synthesis lecular modificat lation from plants clinical Studie Physical Proporties y ADME 7 e Preformulation InvestigationaI N。w Drug Application (IND Submission FDA Revio ClinicalTrials Preclinical Studies (contirued) e Phas Long-term animal toxicity Phase Ill Product formulati Manufacturing and c Package and label design N plicate。n(NDA) FDA Revie Proapproval plant inspection DA actio Postmarketing studio Clinical pharmacology ology Additional indications Adverse reaction reporting Product defect reporting duct line extension
Preclinical Clinical NDA Review Postmarketing Research and Research and development Surveillance development Initial synthesis Adverse and reaction characterization reporting Phase 1 Phase 2 Surveys sampling Phase 3 testin Animal testing Short-term Long-term Inspections Average62years Average 7 years Average 12years FDA 30-day safety review NDA submitted IDA approval +Average of approx 15 years from initial synthesis to approval of NDA-+l
1. Drug Discovery and Drug Design 1) Sources of new drugs 2)a goal drug 3)Methods of drug discovery 4)Alead 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 laboratory. 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