Bioequivalence and Bioavailability Forum

Evaluation of Reference variability [Design Issues]

posted by Nirali – India, 2009-04-17 09:38 (6284 d 15:26 ago) – Posting: # 3551
Views: 5,776

Thank you friends.

Actually, we got the proposal to evaluate reference variability using below design:
"2-period replicate design to assess the intra-subject variability of reference drug, in which reference drug given in both the periods".

Shall it be appropriate design to evaluate reference variability for EU regulatory?

Regards,
NIRALI

Complete thread:

• Evaluation of Reference variability Nirali 2009-04-13 11:53 [Design Issues] 
  • Evaluation of Reference variability KR 2009-04-13 14:39
  • Evaluation of Reference variability Ravi 2009-04-14 06:25
    • Evaluation of Reference variabilityNirali 2009-04-17 07:38
      • Evaluation of Reference variability Ohlbe 2009-04-17 10:04
      • Evaluation of Reference variability Helmut 2009-04-17 13:44
        • Evaluation of Reference variability Nirali 2009-04-18 09:04
          • Evaluation of Reference variability Helmut 2009-04-18 12:31
            • Evaluation of Reference variability Nirali 2009-04-18 19:34
        • Evaluation of Reference variability Marcel 2010-03-16 13:10
          • Evaluation of Reference variability Helmut 2010-03-16 16:01
            • Evaluation of Reference variability ElMaestro 2010-03-16 17:13
              • Some desultory thoughts Helmut 2010-03-16 18:59
            • Evaluation of Reference variability Marcel 2010-03-17 12:47