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)  
Posted by at

1 comment:

  1. RK CLOTHING DESIGNS1 March 2012 at 12:36

    Good stuff. Thank you so so much for sharing your knowledge with world through the Internet. Wonderful blog and post you got here
    paroxetine

    ReplyDelete

Subscribe to: Post Comments (Atom)