薬物動態試験の添付文書への反映

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  • Reflection of Pharmacokinetic study on Package Insert.

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Pharmacokinetics is no longer considered to be a stand-alone discipline, but rather has become an integral factor contributing to assessment of the efficacy, interaction, and adverse reaction of drugs at clinical practice. Accordingly, it is important for the health care professionals, such as physicians and pharmacists, to get the sufficient pharmacokinetic data concerning the prescribed drugs for rational pharmacotherapy. Although the most basic tool for getting information on drugs is package inserts, many health care professionals has lack information on pharmacokinetics from it. It was suggested that more information on pharmacokinetics should be available in package inserts. The following are important pharmacokinetic parameters of drugs that must be expected from pharmacokinetic studies and listed in package inserts: (1) mass balance, (2) pharmacokinetics of active compound, (3) elimination rate and pathways (including data on metabolism, renal excretion and bilary excretion), (4) metabolic organ and enzyme (including data on metabolic interaction), (5) bioavailability (including data on absorption, first-pass effect and food effect), (6) time of half elimination and clearance, (7) single and repeated dose pharmacokinetics (including data on accumulation and linialyty), (8) plasma protein binding, (9) distribution to effective and toxic tissue, (10) pharmacokinetics under special conditions (including data on young, elderly, pregnant, renal disease, and hepatic disease).

収録刊行物

  • 薬物動態

    薬物動態 15 (5), 467-471, 2000

    日本薬物動態学会

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