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Ebook: Development of Successful Phase 2 Analgesic Protocols

eBook“Careful consideration of the points examined in this article will facilitate the crafting of a Phase 2 analgesia protocol design that, if executed properly, will yield supportive data for a successful development program while also alerting the reader to avoid missteps and pitfalls commonly encountered in clinical development.”

Phase 2 is a critical make-or-break phase of product development.This ebook includes key points to consider for Phase 2 Analgesia protocol design, including:

  • A discussion of FDAs comprehensive guidance “Analgesic Indications:    Developing Drug and Biological Products”
  • Defining objectives and clinical endpoints to demonstrate proof of concept
  • Determining dosage to progress to Phase 3
  • Guidelines for optimizing inclusion/exclusion criteria
  • Developing effective Statistical Analysis Plans