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What is ‘dose’ and why is it important in drug development?

‘Dose’ refers to the quantity or concentration of drug that is administered. During pre-clinical research, data is collected on the safety and efficacy at different doses. This data is used to select the dose or doses that will maximize the therapeutic benefits and keep harmful side effects at a minimum. To learn more about dosing and why it is important for drug development, click on the links below.

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Partnership Opportunities

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

FDA Guidance

• FDA: Guidance for Industry – Single Dose Acute Toxicology Testing for Pharmaceuticals