Fixed dose drug combinations (FDCs): rational or irrational: a view point.

摘要

Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form. The Food and Drug Administration, USA defines a combination product as 'a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product' . It is widely accepted that most drugs should be formulated as single compounds. Fixed ratio combina-tion 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.