Under this CFR part it addresses fixed-combination prescription drugs for humans. It states that "Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug." It further explains that special cases of this general rule are where a component is added (i) to enhance the safety or effectiveness of the principal active component and (ii) to minimize the potential for abuse of the principal active ingredient.
Related to 21 CFR 300.50 from a clinical pharmacology and biopharmaceutics perspective, specifically for the scenario where the new combination product is to be administered as an alternative to giving two or more currently marketed, single ingredient products, one is referred to 21 CFR 320.25 (g) as identified above. Here it indicates that an in vivo bioavailability study is needed to determine if the rate and extent of absorption of each active drug ingredient or therapeutic moiety of the combination product is equivalent to the rate and extent of absorption of each active drug ingredient or therapeutic moiety administered concurrently in separate single-ingredient preparations. Information to address drug-drug interaction implications for the two or more drugs in a combination product is also usually needed.
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