Thursday, 24 July 2014

Brand Name Drus Filing Requirements Vs Generic Drugs Filing Requirements

(NDA)                                       Vs                        (ANDA)


1. Chemistry                                                 1. Chemistry

2. Manufacturing                                          2.Manufacturing

3.Testing                                                      3.Testing

4.Labeling                                                    4.Labeling

5.Inspections                                                5.Inspections

6.Animal Studies                                         6.Bioequivalence

7.Clinical Studies

8.Bioavailability


Generic drugs are less expensive because it isn’t necessary to repeat: 
 
Discovery
Pre-clinical studies
Clinical studies (repeating would be unethical)

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