Bioequivalence and Bioavailability Forum • Smoking

Smoking [Design Issues]

posted by ElMaestro – Denmark, 2014-12-18 15:10 (4205 d 10:34 ago) – Posting: # 14110
Views: 15,782

Hi Mahesh M,

❝ Why only Non smokers subjects are required to conduct BE on OIPs or MDI prodcts ?

It is sometimes a good idea to use nonsmokers since smoking directly affects lung function and the ability to inhale and have an API absorbed through the lung mucosa.
The outcome could thus depend a lot on whether the pt. smoked "20 mins ago" or "120 mins ago", figuratively speaking. Smoking can thus play tricks with the intra-subject and between-subject variabilities regardless of whether we talk PK or PD.
Of course there might be compelling scientific arguments for including smokers somehow. If you come up with any, please tell me, I am curious and eager to learn about it.

—
Pass or fail!
ElMaestro

Complete thread:

BE study inclusion & exclusion criteria cher0424 2014-12-16 01:30
- BE study inclusion & exclusion criteria Helmut 2014-12-16 14:53
  - BE study inclusion & exclusion criteria Ohlbe 2014-12-16 17:29
    - BE study inclusion & exclusion criteria cher0424 2014-12-17 02:19
      - Drugs of abuse Helmut 2014-12-17 14:42
        
        Drugs of abuse cher0424 2014-12-18 04:54
        
        Stick to the protocol, but… Helmut 2014-12-18 14:02
    - BE study inclusion & exclusion criteria Helmut 2014-12-17 13:33
  - BE study inclusion & exclusion criteria cher0424 2014-12-17 02:02
    - BE study inclusion & exclusion criteria Helmut 2014-12-17 14:24
- BE study inclusion & exclusion criteria Ohlbe 2014-12-17 17:35
  - Smoking Helmut 2014-12-17 17:48
    - Thanks for solving out cher0424 2014-12-18 02:08
    - Smoking d_labes 2014-12-18 08:08
    - Smoking Mahesh M 2014-12-18 13:50
      - SmokingElMaestro 2014-12-18 14:10
        
        Smoking Mahesh M 2014-12-19 07:14
        
        Smoking ElMaestro 2014-12-19 11:35