Definition:
A medicine that combines two or more active drugs in a single dosage form such as tablet or capsule.
Fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance.
More information:
Guideline on clinical development of fixed combination medicinal products (EMA, 2017)
Codevelopment of two or more new investigational drugs for use in combination (FDA, 2013)
REVIVE Webinar: ‘Test tube to patient: PK/PD of fixed dose beta-lactam/beta-lactamase inhibitor combinations’ by Vincent H. Tam (GARDP, 2020)
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