Bioequivalence and Bioavailability Forum • Parallel BE

Parallel BE [Power / Sample Size]

posted by drcampos – Brazil, 2012-04-10 23:03 (5185 d 12:35 ago) – Posting: # 8403
Views: 9,040

Dear Helmut,

Thank you again for your assistance. Your commentary about the results of the BE report could clarify some of my doubts about parallel design of BE studies. It was almost like a lecture to me!!!!

The results of the BE study (2002) presented in my last message are from this link: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076553_S000_Medroxyprogesterone_BIOPHARMR.pdf (The FDA report presented many deficiencies about this study!)

best regards from Brazil, Daniel

Complete thread:

Parallel BE drcampos 2012-04-10 16:11
- Parallel BE Helmut 2012-04-10 17:20
  - Parallel BEdrcampos 2012-04-10 21:03
    - FDA’s review Helmut 2012-04-11 02:22
      - A reviewer which doesn't review isn't a good reviewer d_labes 2012-04-11 09:57
        
        14 months for 1st review Helmut 2012-04-11 13:51
        
        Guidelines - nonbinding, Scientific advice - nonbinding … d_labes 2012-04-11 15:50
        
        Grumpy ol’ men Helmut 2012-04-11 16:22
        
        Grumpy ol’ men - OT d_labes 2012-04-11 17:04
        
        GDR - OT Helmut 2012-04-11 17:47