Bioequivalence and Bioavailability Forum • Norma = Ley?

Norma = Ley? [Design Issues]

posted by xtianbadillo – Mexico, 2018-01-18 20:51 (3078 d 19:47 ago) – Posting: # 18218
Views: 9,516

❝ ❝ In Mexico for BE you have to perform abuse test by law […]

Maybe I made a lost in translation.
NOM, The Official Mexican Standards are the latest mandatory observation techniques issued by the competent agencies, according to the purposes established in Article 40 of the Federal Law on Metrology and Standardization.

❝ Can you confirm that it is a Ley (law) and not – what I assumed and is stated as such in the document – just a Norma (rule/guideline)?

In Mexico we have to Normas
Norma Oficial Mexicana: Mandatory, like NOM-SSA1-177-2013
Norma Mexicana: they are of voluntary application, like NMX-AA-115-SCFI-2015
Normas can be differentiated by their nomenclature: NOM vs NMX

❝ My Spanish is practically nonexistent. Does “deben realizar” rather mean “should be performed” than “must be performed”?

"Las pruebas cualitativas de abuso de drogas y de embarazo se deben realizar durante el proceso de selección y previo al ingreso en cada periodo del estudio"

My humble opinion is that mean must; other opinions are welcome

Debe = implies that something is to do, it is imminent, mandatory; must be performed
Debe de = ideally, should be performed

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 reserves xtianbadillo 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