Abstract
The development of combination drugs, which integrate two or more active ingredients into a single dosage form, has gained significant traction due to their potential to enhance therapeutic efficacy and improve patient compliance. However, the approval and commercialization of combination drugs face a series of regulatory challenges, including complex clinical trials, safety concerns, and the need for comprehensive manufacturing protocols. This paper explores the key regulatory hurdles in the development of combination drugs, focusing on the requirements from both the pharmaceutical industry and regulatory bodies. Key challenges include the identification of appropriate dosage forms, ensuring consistent drug stability, addressing drug-drug interactions, and navigating the regulatory approval process. Additionally, the paper highlights the evolving regulatory guidelines in regions like the US, Europe, and Asia, which aim to streamline the development of combination therapies while ensuring patient safety.
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