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Therapeutic monitoring of sirolimus: its contribution to optimal prescription.

Abstract：

:It is now common practice to measure immunosuppressive drugs in blood as a guide to therapy. The immunosuppressive drug sirolimus, recently approved for use following kidney transplantation, was developed in the context of this clinical approach. Throughout the early clinical studies, validated analytical techniques based on chromatographic techniques were used to measure the drug. After a brief period in which an immunoassay was available, routine measurements are again being performed by chromatographic assays. In this article the use of blood concentration measurements in the assessment of the early and pivotal clinical trials of the drug is documented. Then, the rationale for the routine monitoring of the drug in clinical practice, a regulatory requirement in some countries, is set out. It is concluded that the development of this compound has benefited from experience gained during the pharmacokinetic assessment of other immunosuppressive drugs. The pharmacokinetic data accumulated on sirolimus have been a key element in formulating guidelines on dosing with this drug, both when used in combination with cyclosporine and when used after cyclosporine withdrawal.

journal_name

Transplant Proc

journal_title

Transplantation proceedings

authors

Holt DW,Denny K,Lee TD,Johnston A

doi

10.1016/s0041-1345(03)00214-8

subject

Has Abstract

pub_date

2003-05-01 00:00:00

pages

157S-161S

issue

3 Suppl

eissn

0041-1345

issn

1873-2623

pii

S0041134503002148

journal_volume

35

pub_type

杂志文章,评审

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