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Microbiology and Infectious Diseases Resources—Vaccines

Discovery and IND-Enabling Activities


Develop targets

Assess in vitro efficacy

Assess activity in vivo (pathogens, all types)

Assess in vivo efficacy

Develop preclinical planning and evaluation

Develop lead candidates

Develop Assays

Assess immunogenicity

Evaluate toxicology

Refine animal models

Process development

Formulate and produce pilot lots

cGMP manufacturing

Obtain regulatory support for compiling documentation necessary for submission of an Investigational New Drug (IND) application and/or Master Files to the Food and Drug Administration (FDA).

Last Updated September 12, 2012