Biomarkers and Surrogate Endpoints: How and When might They Impact Drug Development? | Zendy

Chetan Lathia | Zendy

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Biomarkers and Surrogate Endpoints: How and When might They Impact Drug Development?

Author(s) -

Chetan Lathia

Publication year - 2002

Publication title -

disease markers

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.912

H-Index - 66

eISSN - 1875-8630

pISSN - 0278-0240

DOI - 10.1155/2002/438745

Subject(s) - drug development , drug , pharmaceutical industry , drug discovery , biomarker discovery , medicine , surrogate endpoint , intensive care medicine , computational biology , risk analysis (engineering) , bioinformatics , pharmacology , biology , pathology , proteomics , genetics , gene

As the pharmaceutical industry starts developing novel molecules developed based on molecular biology principles and a better understanding of the human genome, it becomes increasingly important to develop early indicators of activity and/or toxicity. Biomarkers are measurements based on molecular pharmacology and/or pathophysiology of the disease being evaluated that may assist with decision-making in various phases of drug development. The utility of biomarkers in the development of drugs is described in this review. Additionally, the utility of pharmacokinetic data in drug development is described. Development of biomarkers may help reduce the cost of drug development by allowing key decisions earlier in the drug development process. Additionally, biomarkers may be used to select patients who have a high likelihood of benefit or they could be used by clinicians to evaluate the potential for efficacy after start of treatment.

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