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A comparative Human factor study of PF708 and Forteo

Trial Profile

A comparative Human factor study of PF708 and Forteo

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Teriparatide (Primary)
  • Indications Osteoporosis
  • Focus Therapeutic Use
  • Most Recent Events

    • 13 Aug 2020 New trial record
    • 06 Aug 2020 According to a Pfenex media release, Alvogen has recently provided the FDA with an updated CUHF protocol having taken the totality of feedback into account, including a General Advice Letter dated July 2020 and the company intend to commence the study after the FDA's review of the protocol.
    • 06 Aug 2020 According to a Pfenex media release, Following the FDA's April General Advice Letter and as part of an active and on-going dialogue, the FDA has provided additional direction around the methodology to be used in this study focused on a larger group of Forteo experienced users in order to support a therapeutic equivalence evaluation.
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