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I'm reading a WHO guidance, and I am not sure what it means:

6.3.4.1 General considerations 20

Comparative safety data should normally be collected pre-authorization. The extent of collection 21 depends on the type and severity of safety issues known for the reference product. The SBP study 22 population should be followed to provide information on safety events of interest according to the 23 experiences with the reference mAb. Care should be given to compare the nature, severity and 24 frequency of the adverse events between the mAb SBP and the reference product in clinical trials 25 that enrolled a sufficient number of patients treated for an acceptable period of time. Clinical 26 safety issues should be captured throughout clinical development during initial PK and/or PD 27 evaluations and also in the primary clinical study establishing comparability.WHO Guideline

Here, what does "should be collected pre-authorization" mean?

Please help me.

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"pre-authorization" is word that could be replaced with "before authorization." To my ears "pre" sounds like it is being used as a preposition even though it is just a prefix.

"Pre-authorization" specifically is the phase of a trial/experiment one is in before authorization is given. It is technically being used as a temporal noun (I think that is the right label) - a noun used as a adverb to tell when a verb occurs.

This use is similar to:

The oranges should be bought tomorrow


In response to if "pre-" is commonly used as a preposition. In formal settings - no. In the context you give it is not being used as a preposition it just sounds like one when I say the sentence out loud.

However, in casual conversations I would say "pre-" is used in a similar manner to construct new slangy temporal nouns, but this is not very common:

"I loved my life before I had kids" --> I loved my life pre-kids

"Before the internet, kids played outside more" --> Pre-internet, kids played outside more

There was less talk of white nationalism before Trump was elected --> There ws less talk of white nationalism pre-Trump

  • Thanks. Is this usage common? And I changed my question’s subject so that others can search easily. – Mango Gummy Jun 18 at 1:24
  • updated with more info – katatahito Jun 18 at 1:33
  • Thank you very much – Mango Gummy Jun 18 at 1:48

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