Bioequivalence and Bioavailability Forum

drugs of long half life [Design Issues]

posted by Ken Peh – Malaysia, 2013-03-31 08:43 (4466 d 14:23 ago) – Posting: # 10316
Views: 9,542

Dear All,

I have learned from this forum (previous postings) that parallel design is recommended for drug of long half life. I have a request from sponsor to carry out BE on flunarizine. The comparator product (Sibelium, JANSSEN-CILAG S.P.A., Italy) reported in their product insert an elimination half-life of 18 days. To fulfill the washout period of 5 half-life, the washout period will be about 90 days. Does it make sense to run a 2-way cross-over BE study with washout period of 90 days ? No problem with sampling time as there is guideline on the use of truncated AUC0-72hr.

If parallel design is used, intrasubject CV, period effect, etc can not be estimated.

Your comments are highly appreciated especially those who have experience with this drug.

Thank you.

Regards,
Ken

Complete thread:

• drugs of long half lifeKen Peh 2013-03-31 06:43 [Design Issues] 
  • drugs of long half life jag009 2013-04-02 15:17
    • drugs of long half life Helmut 2013-04-02 15:34
      • drugs of long half life jag009 2013-04-02 16:01
        • drugs of long half life Helmut 2013-04-02 16:40
          • parallel FDA d_labes 2013-04-04 08:33
            • parallel FDA jag009 2013-04-05 18:01
            • parallel FDA jag009 2013-04-05 21:10
              • random repeated parallel FDA d_labes 2013-04-08 08:29
                • Proc Mixed: random repeated parallel FDA jag009 2013-04-08 15:36
                  • Proc Mixed: parallel groups with different variabilities d_labes 2013-04-08 16:41
                    • Proc Mixed: parallel groups with different variabilities jag009 2013-04-08 20:22
    • drugs of long half life Ken Peh 2013-04-04 15:03
      • drugs of long half life jag009 2013-04-05 17:45