Multiple choice general knowledge

Name the phase which is an exploratory, first-in-human trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies

  1. phase 1

  2. phase 2a

  3. phase 2b

  4. phase 3

  5. phase 4

  6. phase 0
Reveal answer Fill a bubble to check yourself
F Correct answer
Explanation

Phase 0 (exploratory IND) is a first-in-human trial conducted under limited human exposure, with no therapeutic intent. It's used to gather preliminary pharmacokinetic and pharmacodynamic data before traditional Phase I trials. The FDA issued specific guidance on these studies in 2006.

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