Summary
Small molecule drugs are typically composed of 20 to 100 atoms, while large biologics, such as antibodies, are typically composed of 5000 to 50,000 atoms.
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Pharmaceutical companies have a renewed interest in developing small-molecule compounds, which have shown promise in fighting cancer, polyomaviruses, and major depressive disorder.
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The regulatory process for small-molecule compounds resembles those for large-molecule compounds.
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Summary
Pharmaceutical companies have a renewed interest in developing small-molecule compounds in recent years, as they have shown promise in fighting cancer, polyomaviruses, and major depressive disorder. The regulatory process for small-molecule compounds resembles those for large-molecule compounds, and companies should understand common issues that can occur during the development process. An FDA Compliance Consultancy can help companies navigate the regulatory process for small-molecule compounds, and they can provide free whitepapers to help companies understand the benefits of working with an FDA Compliance Consulting Firm.
A Brief Guide to Small-Molecule Compounds and FDA Regulations
thefdagroup.com
