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Key Pharmacokinetic Essentials of Fixed-Dosed Combination Products: Case Studies and Perspectives

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Abstract

Fixed-dose combinations are gaining popularity because they provide convenience while enhancing patient compliance. Literature examples suggest that many fixed-dose combinations are being rationalized and investigated for their potential utility in therapy. This article provides an introspection into the pharmacokinetic essentials that need to be considered prior to implementing a fixed-dose combination strategy. While the drug–drug interaction potential is an important question for the two drugs in a fixed-dose combination, the occurrence of a drug–drug interaction in itself is not a negative outcome for the proposed fixed-dose combination. However, the magnitude of a drug–drug interaction may require a re-assessment of the doses of the two drugs in a fixed-dose combination. Several case studies are provided and discussed to provide a broad perspective on the topic along with a representative framework and strategy on the development of fixed-dose combinations using key pharmacokinetic parameters.

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Authors and Affiliations

  1. Johns Hopkins Drug Discovery Program, Johns Hopkins University, Baltimore, MD, USA

    Ranjeet Prasad Dash & Rana Rais

  2. Department of Neurology, Johns Hopkins University, Baltimore, MD, USA

    Ranjeet Prasad Dash & Rana Rais

  3. Zydus Research Centre, Moraiya, Ahmedabad, Gujarat, 382210, India

    Nuggehally R. Srinivas

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  1. Ranjeet Prasad Dash
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Correspondence to Nuggehally R. Srinivas.

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Ranjeet Prasad Dash, Rana Rais, and Nuggehally R. Srinivas have no conflicts of interest or competing interests directly relevant to the contents of this article.

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Dash, R.P., Rais, R. & Srinivas, N.R. Key Pharmacokinetic Essentials of Fixed-Dosed Combination Products: Case Studies and Perspectives. Clin Pharmacokinet 57, 419–426 (2018). https://doi.org/10.1007/s40262-017-0589-2

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