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Suppose a new antibiotic in an iv formulation exists and has been approved When you want to test the oral formulation and phase 3 comes you should test it against what? A placebo or the iv formulation of the same drug? And what comparison would be more useful in that case?

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    This might vary from one country to another, so you should edit your question to clarify which you're asking about. – Carey Gregory Jul 11 '19 at 19:46
  • Edited for clarity – Alberto Andrade Jul 12 '19 at 12:03
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    This is a completely different question from what you originally asked, and now it's not so clear what you're asking. The title also asks a different question than the body. What do you mean by what should be done regardless of regulations? "Should be done" according to who? Following regulations is the only path to having the drug approved. – Carey Gregory Jul 12 '19 at 13:58
  • Going to reformulate everything – Alberto Andrade Jul 12 '19 at 19:00

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