Simple bioequivalence criteria: Are they relevant to critical dose drugs? Experience gained from cyclosporine

被引：42

作者：

Johnston, A

Keown, PA

Holt, DW

机构：

[1] UNIV BRITISH COLUMBIA,IMMUNOL LAB,VANCOUVER HOSP & HLTH SCI CTR,VANCOUVER,BC V5Z 1M9,CANADA

[2] UNIV LONDON ST GEORGES HOSP,SCH MED,ANALYT UNIT,LONDON SW17 0RE,ENGLAND

来源：

THERAPEUTIC DRUG MONITORING | 1997年 / 19卷 / 04期

关键词：

bioequivalence; therapeutic equivalence; critical dose drugs; clinical trials; cyclosporine;

D O I：

10.1097/00007691-199708000-00002

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

A critique of the current bioequivalence regulations is presented with reference to critical dose drugs. Using the development of a new cyclosporine formulation as an example, the deficiencies in current bioequivalence testing guidelines are examined and discussed. Based on the experience gained with cyclosporine, recommendations are made on how therapeutic equivalence, rather than just bioequivalence, should be established.

引用

页码：375 / 381

页数：7

共 64 条

[1] PHARMACOKINETIC STUDIES OF SANDIMMUNE NEORAL VS SANDIMMUNE IN LIVER-TRANSPLANT RECIPIENTS [J].