The vaccine Development Pathway

David W C Beasley

doi:10.1002/9781118638033.ch2

The vaccine Development Pathway

David W C Beasley

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

2 Scopus citations

Abstract

The decision to develop a vaccine is based on analysis of need and, in most cases, potential returns on the significant investment of time and resources required to move a candidate product from initial development through to licensure. The vaccine development pathway encompasses a series of highly regulated milestones designed to assess the safety and efficacy of a candidate vaccine via nonclinical testing, using animal models and in vitro assays, and in phased clinical trials in humans. Regulatory oversight also aims to ensure the consistency of its manufacture during the investigational phases and following its approval and licensure.

Original language	English (US)
Title of host publication	Vaccinology
Subtitle of host publication	An Essential Guide
Publisher	Wiley-Blackwell
Pages	33-42
Number of pages	10
ISBN (Electronic)	9781118638033
ISBN (Print)	9780470656167
DOIs	https://doi.org/10.1002/9781118638033.ch2
State	Published - Dec 9 2014

Keywords

Biologics license application
Clinical trials
Investigational new drug
National regulatory authority
Nonclinical testing

ASJC Scopus subject areas

General Medicine

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10.1002/9781118638033.ch2

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title = "The vaccine Development Pathway",

abstract = "The decision to develop a vaccine is based on analysis of need and, in most cases, potential returns on the significant investment of time and resources required to move a candidate product from initial development through to licensure. The vaccine development pathway encompasses a series of highly regulated milestones designed to assess the safety and efficacy of a candidate vaccine via nonclinical testing, using animal models and in vitro assays, and in phased clinical trials in humans. Regulatory oversight also aims to ensure the consistency of its manufacture during the investigational phases and following its approval and licensure.",

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AB - The decision to develop a vaccine is based on analysis of need and, in most cases, potential returns on the significant investment of time and resources required to move a candidate product from initial development through to licensure. The vaccine development pathway encompasses a series of highly regulated milestones designed to assess the safety and efficacy of a candidate vaccine via nonclinical testing, using animal models and in vitro assays, and in phased clinical trials in humans. Regulatory oversight also aims to ensure the consistency of its manufacture during the investigational phases and following its approval and licensure.

KW - Biologics license application

KW - Clinical trials

KW - Investigational new drug

KW - National regulatory authority

KW - Nonclinical testing

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EP - 42

BT - Vaccinology

PB - Wiley-Blackwell

ER -

The vaccine Development Pathway

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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