NDA vs ANDA Comparison
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It describes the NDA and ANDA repuirements for FDA approval and differences between them
![New Drug Application(NDA) Vs Abbreviated new drug application (ANDA) ,[object Object],[object Object],[object Object],[object Object],Name: Sneya Priya Year : M.Pharm( Pharmaceutics) College: Manipal college of Pharmaceutical Scieces(MCOPS), Manipal Email id: snehpriya123@gmail.com](https://image.slidesharecdn.com/newdrugapplicationndavsabbreviatednewdrugapplicationanda-12647240246271-phpapp01/85/new-drug-applicationnda-vs-abbreviated-new-drug-application-anda-1-320.jpg)
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NDA vs ANDA Comparison
- 5. New Drug Development and Review Process Steps from Test Tube to New Drug Application Review
- 6. Phases of clinical testing Phase Number of patients Length Purpose Percent successfully completing Phase1 20-100 Several months Mainly safety 67 Phase2 Up to several hundred Several months to two years Some short-term safety but mainly effectiveness 45 Phase3 Several hundred to several thousand 1-4 years Safety, effectiveness, dosage 5-10
- 30. CONCLUSION NDA ANDA Applicable for new drug Applicable for generic drug Take longer time ( 12-15 years) Compare to NAD less time taken(1-2 years) More expenditure of money Comparatively less Cost of drugs are more Cost of drugs are less Nonclinical studies and clinical investigations are essential Nonclinical studies and clinical investigations are nonessential except bioavailability and bioequivalence