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Drug development surrogate markers

Step 4 for those involved in the process is to discuss and decide on the measures of quality pertinent to the drug being evaluated. These become the criteria for drug use. They are developed by the clinicians using the medications and are often based on both evidence from the literature as well as local experience. Often, surrogate markers of disease or outcome, or both, must be used if more clinically relevant data are not readily available in computerized records or in the patient s actual chart. [Pg.199]

Wagner JA. Overview of biomarkers and surrogate endpoints in drug development. Dis Markers. 2002 18 41-46. [Pg.311]

Surrogate Markers in Different Stages of Drug Development Processes... [Pg.42]

Today it appears that future trends in drug development and industrial pharmacokinetics will be driven by three factors the emergence of genomics, advances in bioanalytical technology, and the need for rapid proof of concept and better surrogate markers for drug efficacy. [Pg.93]

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See also in sourсe #XX -- [ Pg.406 ]



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