Bioequivalence and Bioavailability Forum • OROS residence time

OROS residence time [Design Issues]

posted by drsinghs – India, 2012-10-05 14:14 (5013 d 06:36 ago) – Posting: # 9314
Views: 6,807

❝ Even if an effect on motility is not described as an effect or adverse event of your drug, I really doubt any regulator would accept such an exclusion.

Dear Ohlbe,

Before I ask anything Can I request you to have a look on below link and request your comment?

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075289.PDF

Thanks & regards,
drsinghs

Complete thread:

OROS residence time ABE1580 2012-09-13 09:55
- OROS residence time Helmut 2012-09-13 14:28
- OROS residence time jag009 2012-09-13 17:34
  - OROS residence time Helmut 2012-09-13 17:45
    - OROS residence time jag009 2012-09-13 19:45
      - OROS residence time ABE1580 2012-09-14 07:56
        
        OROS residence time ABE1580 2012-09-14 11:14
        
        OROS residence time Helmut 2012-09-14 13:58
        
        OROS residence time jag009 2012-09-17 16:47
        
        OROS residence time Helmut 2012-09-17 16:56
    - OROS residence time jag009 2012-09-18 17:11
    - OROS residence time drsinghs 2012-10-05 06:04
      - OROS residence time Ohlbe 2012-10-05 10:40
        
        OROS residence timedrsinghs 2012-10-05 12:14
        
        And where? Helmut 2012-10-05 13:34
        
        And where? drsinghs 2012-10-05 14:16
        
        And where? Ohlbe 2012-10-05 16:00
        
        And where? jag009 2012-10-12 23:05