Sensitization test [Regulatives / Guidelines]

posted by Kelen – Brazil, 2023-06-30 15:13 (354 d 03:05 ago) – Posting: # 23639
Views: 1,169

I would like to ask help to understand the difference between "subjects potencially sensitized" and "subjects sensitized" that are mentioned in this part of the FDA guidance - Assessing the irritation and sensitization potential of transdermal and topical delivery systems for ANDAs.

Applicants should provide descriptive statistics comparing both the number and the proportion of subjects potencially sensitized to each TDS unit and both the number and the proportion of subjects sensitized to each TDS unit.

Thanks a lot in advance!

Edit: Guidance linked. [Helmut]

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