Saturday 8 October 2011

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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1 comment:

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