SURROGATE BIOCHEMICAL MARKERS - PRECISE MEASUREMENT FOR STRATEGIC DRUG AND BIOLOGICS DEVELOPMENT

被引:23
作者
LEE, JW [1 ]
HULSE, JD [1 ]
COLBURN, WA [1 ]
机构
[1] HARRIS LABS INC,PHOENIX,AZ 85040
关键词
D O I
10.1002/j.1552-4604.1995.tb04089.x
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
More efficient drug and biologics development is necessary for future success of pharmaceutical and biotechnology companies. One way to achieve this objective is to use rationally selected surrogate markers to improve the early decision-making process. Using typical clinical chemistry methods to measure biochemical markers may not ensure adequate precision and reproducibility. In contrast, using analytical methods that meet good laboratory practices along with rational selection and validation of biochemical markers con give those who use them a competitive advantage over those who do not by providing meaningful data for earlier decision making.
引用
收藏
页码:464 / 470
页数:7
相关论文
共 24 条
[1]  
APPLE FS, 1994, J CLIN IMMUNOASSAY, V17, P6
[2]   CORONARY ANGIOGRAPHIC CHANGES WITH LOVASTATIN THERAPY - THE MONITORED ATHEROSCLEROSIS REGRESSION STUDY (MARS) [J].
BLANKENHORN, DH ;
AZEN, SP ;
KRAMSCH, DM ;
MACK, WJ ;
CASHINHEMPHILL, L ;
HODIS, HN ;
DEBOER, LWV ;
MAHRER, PR ;
MASTELLER, MJ ;
VAILAS, LI ;
ALAUPOVIC, P ;
HIRSCH, LJ .
ANNALS OF INTERNAL MEDICINE, 1993, 119 (10) :969-976
[3]   THE ATRIAL PEPTIDE SYSTEM IN CARDIAC DISEASE [J].
BURNETT, JC .
AMERICAN JOURNAL OF HYPERTENSION, 1988, 1 (04) :S410-S420
[4]   SIMULTANEOUS PHARMACOKINETIC AND PHARMACODYNAMIC MODELING [J].
COLBURN, WA .
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1981, 9 (03) :367-388
[5]  
COLBURN WA, 1992, APPL CLIN TRIALS, V1, P42
[6]  
COLBURN WA, 1992, IN VIVO STUDY DRUG A, P17
[7]   COST OF INNOVATION IN THE PHARMACEUTICAL-INDUSTRY [J].
DIMASI, JA ;
HANSEN, RW ;
GRABOWSKI, HG ;
LASAGNA, L .
JOURNAL OF HEALTH ECONOMICS, 1991, 10 (02) :107-142
[8]  
DZAU VJ, 1992, J HYPERTENS, V10, pS3
[9]   ANGIOTENSIN-II RECEPTOR BLOCKADE - AN INNOVATIVE APPROACH TO CARDIOVASCULAR PHARMACOTHERAPY [J].
EBERHARDT, RT ;
KEVAK, RM ;
KANG, PM ;
FRISHMAN, WH .
JOURNAL OF CLINICAL PHARMACOLOGY, 1993, 33 (11) :1023-1038
[10]  
FELDMAN PL, 1993, CHEM ENG NEWS, P26