TY - JOUR
T1 - Key Pharmacokinetic Essentials of Fixed-Dosed Combination Products
T2 - Case Studies and Perspectives
AU - Dash, Ranjeet Prasad
AU - Rais, Rana
AU - Srinivas, Nuggehally R.
PY - 2017/8/8
Y1 - 2017/8/8
N2 - 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.
AB - 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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U2 - 10.1007/s40262-017-0589-2
DO - 10.1007/s40262-017-0589-2
M3 - Article
C2 - 28791593
AN - SCOPUS:85027018759
SP - 1
EP - 8
JO - Clinical Pharmacokinetics
JF - Clinical Pharmacokinetics
SN - 0312-5963
ER -