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Surrogate Biochemical Markers: Precise Measurement for Strategic Drug and Biologics Development
Author(s) -
Lee Jean W.,
Hulse James D.,
Colburn Wayne A.
Publication year - 1995
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1995.tb04089.x
Subject(s) - drug development , risk analysis (engineering) , surrogate endpoint , biochemical engineering , computer science , drug , process (computing) , selection (genetic algorithm) , contrast (vision) , computational biology , management science , medicine , microbiology and biotechnology , machine learning , pharmacology , engineering , artificial intelligence , biology , operating system
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 can give those who use them a competitive advantage over those who do not by providing meaningful data for earlier decision making.