Bioequivalence and Bioavailability Forum

BE using non RLD [Regulatives / Guidelines]

posted by luvblooms  – India, 2013-08-05 07:57 (4709 d 05:45 ago) – Posting: # 11195
Views: 6,387
(edited on 2013-08-05 08:21)

Dear John


Done that (submitted an ANDA with a BE on non RLD lower strength) for a highly variable statin and also got approval (along with bio-waiver for all the proportional lower strengths).

Never got a query from FDA asking about why RLD has not been dosed.

It could be one of its kind case but such things happen!!!

Complete thread:

• BE using non RLD zheng791 2013-08-03 21:45 
  • BE using non RLD ElMaestro 2013-08-03 22:17
    • BE using non RLD jag009 2013-08-03 22:51
      • BE using non RLD zheng791 2013-08-03 23:55
        • BE using non RLD jag009 2013-08-04 20:20
          • BE using non RLDluvblooms 2013-08-05 05:57
            • BE using non RLD ElMaestro 2013-08-05 10:44
              • BE using non RLD luvblooms 2013-08-05 13:46
                • BE using non RLD ElMaestro 2013-08-05 13:59
                  • BE using non RLD luvblooms 2013-08-05 14:31
                    • BE using non RLD ElMaestro 2013-08-05 15:04
                    • Very strange! jag009 2013-08-05 16:02
                      • Very strange! Helmut 2013-08-05 16:37
                        • Very strange! jag009 2013-08-05 16:45
                      • Very strange! luvblooms 2013-08-05 17:30
                        • Very strange! jag009 2013-08-05 17:52