Types of clinical studies

Lewis J. Smith

doi:10.1007/978-0-387-69094-0_5

Types of clinical studies

Lewis J. Smith^*

^*Corresponding author for this work

Medicine, Pulmonary Division

Research output: Chapter in Book/Report/Conference proceeding › Chapter

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 language	English (US)
Title of host publication	Drug and Biological Development
Subtitle of host publication	From Molecule to Product and Beyond
Publisher	Springer US
Pages	107-122
Number of pages	16
ISBN (Print)	9780387329789
DOIs	https://doi.org/10.1007/978-0-387-69094-0_5
State	Published - Dec 1 2007

ASJC Scopus subject areas

General Medicine
General Agricultural and Biological Sciences

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10.1007/978-0-387-69094-0_5

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Types of clinical studies

Abstract

ASJC Scopus subject areas

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