+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

A strategic view on the use of pharmacodynamic biomarkers in early clinical drug development



A strategic view on the use of pharmacodynamic biomarkers in early clinical drug development



Idrugs 9(12): 849-853



Early-phase clinical trials have traditionally focused on the safety, tolerability and pharmacokinetic properties of a therapeutic candidate, while questions regarding efficacy have been left unanswered until phase II clinical development. Although an understanding of all of these parameters is unarguably essential to the successful development of a drug candidate, this information is insufficient. Biomarkers are increasingly being used in early drug development to allow for the exploration of pharmacodynamic effects of targeted therapeutics before clinical signs and symptoms are evaluated. The trend of using pharmacodynamic biomarkers will continue and, ultimately, may enable these biomarkers to be used routinely to demonstrate the impact of a compound on the treatment of a disease, and to aid in the selection of therapeutic doses and regimens based on accurate measures of human physiological responses. Biomarkers are also beginning to be used to determine those patients who are most likely to respond to a therapeutic, and thereby improve treatment outcomes while avoiding the administration of a drug to individuals who are unlikely to benefit. This article describes a strategy that is being used to achieve these aims for biomarkers, and discusses how biomarkers can be used to identify information that can be applied back into to the drug discovery process.

Please choose payment method:






(PDF emailed within 1 workday: $29.90)

Accession: 048121685

Download citation: RISBibTeXText

PMID: 17139572


Related references

Pharmacokinetics and pharmacodynamic biomarkers in early oncology drug development. European Journal of Cancer 45(Suppl. 1): 436-438, 2009

Impact of pharmacokinetic-pharmacodynamic modelling in early clinical drug development. European Journal of Pharmaceutical Sciences 109s: S53-S58, 2017

Beyond biomarkers: an opportunity to address the 'pharmacodynamic gap' in pediatric drug development. Biomarkers in Medicine 4(6): 783-786, 2010

Pharmacodynamic Biomarkers in Model-Based Drug Development in Oncology. Current Clinical Pharmacology 6(1): 30-40, 2011

Pharmacodynamic biomarkers in model-based drug development in oncology. Current Clinical Pharmacology 6(1): 30-40, 2011

Strategic approach to fit-for-purpose biomarkers in drug development. Annual Review of Pharmacology and Toxicology 48: 631-651, 2007

Use of pharmacokinetic/pharmacodynamic biomarkers to support rational cancer drug development. Biomarkers in Medicine 1(3): 399-417, 2007

COPD biomarkers as tools for decision making in early clinical drug development. Biomarkers in Medicine 10(5): 513-524, 2016

Urinary kidney biomarkers for early detection of nephrotoxicity in clinical drug development. British Journal of Clinical Pharmacology 77(6): 947-957, 2014

Biomarkers and biomeasures: key enablers for pharmacokinetic-pharmacodynamic modeling in drug discovery and development. Bioanalysis 4(10): 1143-1145, 2012

Imaging and other biomarkers in early clinical studies: one step at a time or re-engineering drug development?. Journal of Clinical Oncology 23(24): 5417-5419, 2005

Biomarkers for early detection of non-alcoholic steatohepatitis: implications for drug development and clinical trials. Current Drug Targets 14(11): 1357-1366, 2013

The applications of biomarkers in early clinical drug development to improve decision-making processes. Ernst Schering Research Foundation Workshop 2007(59): 29-45, 2007

Genomic biomarkers for a binary clinical outcome in early drug development microarray experiments. Journal of Biopharmaceutical Statistics 22(1): 72-92, 2012

Use of translational pharmacodynamic biomarkers in early-phase clinical studies for schizophrenia. Biomarkers in Medicine 8(1): 29-49, 2014