Bioequivalence and Bioavailability Forum • IRB reserves

IRB reserves [Design Issues]

posted by xtianbadillo – Mexico, 2018-01-18 09:32 (2288 d 22:17 ago) – Posting: # 18199
Views: 6,644

❝ Is the drug screening mandatory??

In Mexico for BE you have to perform abuse test by law
"8.7.14 Qualitative evidence of drug abuse and pregnancy must be performed during the selection process and prior to admission in each study period" NOM-177-SSA1-2013.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Document linked. [Helmut]

Complete thread:

IRB reserves Norah 2018-01-16 08:31
- Screening for illicit drugs Helmut 2018-01-16 11:18
  - Screening for illicit drugs Norah 2018-01-16 11:54
    - Screening for illicit drugs ElMaestro 2018-01-16 12:44
      - Screening for illicit drugs Norah 2018-01-16 13:57
- IRB reserves Relaxation 2018-01-16 18:18
  - IRB reserves ElMaestro 2018-01-16 22:16
    - IRB reserves Norah 2018-01-17 15:08
    - Recreational use ≠ abuse; definition of health Helmut 2018-01-17 15:31
- IRB reservesxtianbadillo 2018-01-18 08:32
  - IRB reserves Norah 2018-01-18 08:35
  - Norma = Ley? Helmut 2018-01-18 10:01
    - Norma = Ley? xtianbadillo 2018-01-18 19:51
      - Norma Oficial Mexicana (NOM): Mandatory Helmut 2018-01-19 00:21