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Vaccines: A review of immune‐based interventions to prevent and treat disease
Author(s) -
Alemayehu Demissie,
Utt Eric,
Knirsch Charles
Publication year - 2015
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.397
Subject(s) - psychological intervention , clinical trial , disease , intensive care medicine , medicine , infectious disease (medical specialty) , productivity , public health , risk analysis (engineering) , business , economic growth , economics , psychiatry , nursing , pathology
The enormous gains made in public health during the 20th century, through the prevention and treatment of infectious disease, have contributed to dramatic improvements in the quality and length of the human lifespan. Continued advances in medicine are dependent on addressing several challenges including the increase in existing and new resistance to antibiotics, the decrease in productivity of the research and development (R&D) ecosystem, uncertain regulatory pathways, and an economic environment that rewards innovation for developing therapeutics that involve long cycle times from idea to a product. In this article, we consider important issues pertaining to the development of vaccines with particular emphasis on preclinical requirements, optimal dose selection, design, execution, and reporting of clinical trials for regulatory submission, planning and implementation of post‐approval life‐cycle programs, and emerging themes in therapeutic vaccines.