Types of clinical studies

Lewis J. Smith*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

4 Scopus citations

Abstract

To obtain approval from the Food and Drug Administration (FDA) or an equivalent agency outside the United States to market and sell a new drug or biologic product for use in humans, a series of clinical studies must be performed. These clinical studies exist in four phases. Each phase has specific and differing requirements for patient types, goals, inclusion/exclusion criteria, design features, and expected outcomes. Combined, they build the patient care database for safety and efficacy that hopefully will lead to product approval.

Original languageEnglish (US)
Title of host publicationDrug and Biological Development
Subtitle of host publicationFrom Molecule to Product and Beyond
PublisherSpringer US
Pages107-122
Number of pages16
ISBN (Print)9780387329789
DOIs
StatePublished - Dec 1 2007

ASJC Scopus subject areas

  • Medicine(all)
  • Agricultural and Biological Sciences(all)

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