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Critical Components Of The Preclinical Stage Of FDA Drug Approval

Last time, I published a post that posed the question: why are prescription drugs in the U.S. so expensive? Today’s post is the first in a brief series that will attempt to provide an answer by looking each stage of the FDA drug approval process, starting with preclinical. Below are the key components of the preclinical stage.

Compound Development

The sponsor, defined as the person or organization that takes responsibility for and initiates a clinical investigation, develops a new drug compound and seeks to have it approved by the FDA for sale in the United States.

Animal Testing

The sponsor tests the compound on animals for toxicity. (Animal testing is required.) Multiple species are used to gather basic information on the safety of the compound being investigated and researched.

Investigational New Drug (IND) Application

Based on the results from the initial testing, the sponsor submits an investigational new drug (IND) application to the FDA. The IND also includes a plan for testing the drug on humans. The FDA reviews the IND to ensure that the proposed studies/clinical trials do not place human subjects at unreasonable risk of harm. The FDA also verifies that there is adequate informed consent and human subject protection.

Following successful completion of the preclinical stage, the new drug advances to the next stage. Stay tuned to learn more about what happens in the clinical stage. In the meantime, check out our latest guide by filling out the form below.

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Marin Richeson

Marin joined the life sciences industry in 2001. Over the course of her tenure, she has held roles in clinical finance, IT, quality assurance, and validation. The diversity of her experience provides her with a unique perspective on the interconnectedness of this complex, multi-faceted industry. Marin Richeson is a lead business consultant in Perficient's life sciences practice.

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