The IND application is the primary means through which the FDA allows the testing of new drugs and biologics in humans. The path to a successful IND can be long and resource intensive. The first key to success is understanding the IND process and how to best support your clinical program. Clinical Pharmacology Modeling and Simulation (CPMS) provides expert advice and strategy for preclinical and clinical pharmacology and pharmacokinetics (PK), including authorship of these sections in briefing packages, IND modules, clinical protocols and investigator brochures. We offer subject matter expert representation at Pre-IND meetings to address agency questions and concerns to begin clinical development.
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