What are Pharmaceutical Alternatives ?

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Lakshmana Pramod's picture

Answer: 
Drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety, but are different salts, esters, or complexes of that moiety, or are different dosage forms or strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs. quinidine sulfate, 200mg capsules). Data are generally not available for FDA to make the determination of tablet to capsule bioequivalence. Different dosage forms and strengths within a product line by a single manufacturer are thus pharmaceutical alternatives, as are extended-release products when compared with immediate-release or standard-release formulations of the same active ingredient.

G.L.Pramod, B.Pharmacy, MS.c(Ph.Regulatory Affairs), Executive, EU Regulatoty Affairs, ELC, Ahemdabad.

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