Bioequivalence and Bioavailability Forum • Subject selection

Subject selection [Design Issues]

posted by ele2008 – Korea, 2014-10-23 18:47 (4261 d 19:31 ago) – Posting: # 13776
Views: 28,027

Thank you Helmut for the editing.

I just read this article titled "Gender Differences in Drug Bioequivalence: Time to Rethink Practices"¹

Apparently, intra-individual variability is dependent on many factors (so far genetics and gender have been confirmed, I assume age and health condition are such factors as well).

It seems impossible for any BE study to balance all the influencing factors in a study design, unless they use a huge sample size. therefore I am now more convinced by the viewpoint from the EMA. I read again what you posted:

"We are trying to determine if two dosage forms of the same drug behave similarly. Therefore we want to keep any other variability not due to the dosage forms at a minimum. We choose the least variable “test tube”, that is, a healthy volunteer."

In the end of article,the author says "Before the twentieth century, men used to perform women’s roles in theater, as a reflection of sexual puritanism. Until recently, women were not allowed to vote in many countries, and this reality continues today in some jurisdictions. It was assumed that men knew what was “good for women.” In the case of regulatory reality, the current approach is clearly not good for women, as the science shows."

Really, is women not being included into BE studies a sign of sex discrimination? I did not know that. (Speaking as a woman myself)

1. Koren G, Nordeng H, MacLeod S
Gender differences in drug bioequivalence: time to rethink practices.
Clin Pharmacol Ther. 2013 Mar;93(3):260-2.
doi 10.1038/clpt.2012.233. Epub 2012 Dec 3.

Complete thread:

Subject selection ele2008 2014-10-16 05:06
- Genotyping in BE Helmut 2014-10-16 15:04
  - Genotyping in BE ele2008 2014-10-16 16:18
    - Genotyping in BE nobody 2014-10-16 17:43
      - Genotyping in BE Helmut 2014-10-16 18:13
        
        Genotyping in BE nobody 2014-10-16 18:24
        
        Any experiences? Helmut 2014-10-17 19:30
        
        Any experiences? nobody 2014-10-17 20:04
        
        Any experiences? Helmut 2014-10-18 15:04
        
        Any experiences? nobody 2014-10-20 08:06
        
        Any experiences? Helmut 2014-10-20 13:00
        
        Any experiences? nobody 2014-10-20 14:21
- Subject selection ele2008 2014-10-23 05:25
  - Subject selectionele2008 2014-10-23 16:47
    - Subject selection ElMaestro 2014-10-23 17:25
      - Subject selection nobody 2014-10-23 17:53
    - Editing posts Helmut 2014-10-23 17:54
    - ♀ on a mission? Helmut 2014-10-23 19:50