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What is long term toxicology and why is it important in drug development?

Long term toxicology are studies on the toxic effects of a compound when it is administered over an extended period of time. Long term toxicology studies usually use at least two animal species and three different dose levels. The duration of the study is proportional to the expected clinical use. Testing includes behavioral observations and basic physical examinations. To learn more about long term toxicology and why it is important for drug development, click on the links below.

• NCRR and Indiana University: Pharmacology & Toxicology – The Basics

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FDA Guidance

• FDA: Guidance on Pharm / Tox Studies
• FDA: Guidance for Industry – Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

Partnership Opportunities

• Therapies for Rare and Neglected Diseases, NIH: About the TRND Program
• Therapies for Rare and Neglected Diseases, NIH: Apply to TRND