Abstract
Over the past 30 years, much has been learned about the impact of development on drug disposition (i.e., pharmacokinetics). This is not true concerning drug action (i.e., pharmacodynamics). As a consequence, in clinical therapeutics and the drug development process, assumptions are often times made that a specific systemic drug exposure that is associated with desired drug action in adults will produce the same response in children. A review of the literature would suggest that this assumption may, in some cases, be an errant one. The relative paucity of information concerning developmental pharmacodynamics is associated with the challenge of assessing and quantitating drug response in vivo in infants and children. An approach to overcome these difficulties has been the evolution of biomarkers that are functional in nature in that they are capable of measuring drug response in both a time and age dependent fashion. The purpose of this review is to illustrate how functional biomarkers capable of assessing drug response/ effect in the developing child are developed and being evaluated for their clinical utility.
Keywords: Biomarkers, development, pharmacokinetics, pharmacodynamics.
Current Pharmaceutical Design
Title:Functional Biomarkers: an Approach to Bridge Pharmacokinetics and Pharmacodynamics in Pediatric Clinical Trials
Volume: 21 Issue: 39
Author(s): Gregory L. Kearns and Michael Artman
Affiliation:
Keywords: Biomarkers, development, pharmacokinetics, pharmacodynamics.
Abstract: Over the past 30 years, much has been learned about the impact of development on drug disposition (i.e., pharmacokinetics). This is not true concerning drug action (i.e., pharmacodynamics). As a consequence, in clinical therapeutics and the drug development process, assumptions are often times made that a specific systemic drug exposure that is associated with desired drug action in adults will produce the same response in children. A review of the literature would suggest that this assumption may, in some cases, be an errant one. The relative paucity of information concerning developmental pharmacodynamics is associated with the challenge of assessing and quantitating drug response in vivo in infants and children. An approach to overcome these difficulties has been the evolution of biomarkers that are functional in nature in that they are capable of measuring drug response in both a time and age dependent fashion. The purpose of this review is to illustrate how functional biomarkers capable of assessing drug response/ effect in the developing child are developed and being evaluated for their clinical utility.
Export Options
About this article
Cite this article as:
Kearns L. Gregory and Artman Michael, Functional Biomarkers: an Approach to Bridge Pharmacokinetics and Pharmacodynamics in Pediatric Clinical Trials, Current Pharmaceutical Design 2015; 21 (39) . https://dx.doi.org/10.2174/1381612821666150901105337
DOI https://dx.doi.org/10.2174/1381612821666150901105337 |
Print ISSN 1381-6128 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4286 |
Call for Papers in Thematic Issues
"Tuberculosis Prevention, Diagnosis and Drug Discovery"
The Nobel Prize-winning discoveries of Mycobacterium tuberculosis and streptomycin have enabled an appropriate diagnosis and an effective treatment of tuberculosis (TB). Since then, many newer diagnosis methods and drugs have been saving millions of lives. Despite advances in the past, TB is still a leading cause of infectious disease mortality ...read more
Current Pharmaceutical challenges in the treatment and diagnosis of neurological dysfunctions
Neurological dysfunctions (MND, ALS, MS, PD, AD, HD, ALS, Autism, OCD etc..) present significant challenges in both diagnosis and treatment, often necessitating innovative approaches and therapeutic interventions. This thematic issue aims to explore the current pharmaceutical landscape surrounding neurological disorders, shedding light on the challenges faced by researchers, clinicians, and ...read more
Emerging and re-emerging diseases
Faced with a possible endemic situation of COVID-19, the world has experienced two important phenomena, the emergence of new infectious diseases and/or the resurgence of previously eradicated infectious diseases. Furthermore, the geographic distribution of such diseases has also undergone changes. This context, in turn, may have a strong relationship with ...read more
Melanoma and Non-Melanoma Skin Cancer Treatment: Standard of Care and Recent Advances
In this thematic issue, we aim to provide a standard of care of the diagnosis and treatment of melanoma and non-melanoma skin cancer. The editor will invite authors from different countries who will write review articles of melanoma and non-melanoma skin cancers. The Diagnosis, Staging, Surgical Treatment, Non-Surgical Treatment all ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Presynaptic Cell Dependent Modulation of Inhibition in Cortical Regions
Current Neuropharmacology MicroRNA Involvement in the Pathogenesis of Neuroblastoma: Potential for MicroRNA Mediated Therapeutics
Current Pharmaceutical Design Targeted Toxins for Glioblastoma Multiforme: Pre-Clinical Studies and Clinical Implementation
Anti-Cancer Agents in Medicinal Chemistry Oxidation Chemistry of Catecholamines and Neuronal Degeneration: An Update
Current Medicinal Chemistry FoxO Transcription Factors and Regenerative Pathways in Diabetes Mellitus
Current Neurovascular Research From the Oxygen to the Organ Protection: Erythropoietin as Protagonist in Internal Medicine
Cardiovascular & Hematological Agents in Medicinal Chemistry Beyond the Selective Inhibition of Histone Deacetylase 6
Mini-Reviews in Medicinal Chemistry Mechanisms of Tau Self-Aggregation and Neurotoxicity
Current Alzheimer Research An Expanding Appreciation of the Role Chemokine Receptors Play in Cancer Progression
Current Pharmaceutical Design A Proteomic Analysis of Mitochondrial Complex III Inhibition in SH-SY5Y Human Neuroblastoma Cell Line
Current Proteomics A Common Biological Mechanism in Cancer and Alzheimers Disease?
Current Alzheimer Research The Sigma Receptor: Evolution of the Concept in Neuropsychopharmacology
Current Neuropharmacology Phenolic Acids Exert Anticholinesterase and Cognition-Improving Effects
Current Alzheimer Research Threes Company: Regulation of Cell Fate by Statins
Current Drug Targets - Cardiovascular & Hematological Disorders Cannabinoid Receptors as Therapeutic Targets
Current Pharmaceutical Design The Mitochondrial Dynamics of Alzheimers Disease and Parkinsons Disease Offer Important Opportunities for Therapeutic Intervention
Current Pharmaceutical Design Alzheimer’s Disease and Molecular Chaperones: Current Knowledge and the Future of Chaperonotherapy
Current Pharmaceutical Design Electrochemical Study of Ellipticine Interaction with Single and Double Stranded Oligonucleotides
Anti-Cancer Agents in Medicinal Chemistry Antioxidant Agents in Alzheimers Disease
Central Nervous System Agents in Medicinal Chemistry Dynamic Expression of MicroRNAs (183, 135a, 125b, 128, 30c and 27a) in the Rat Pilocarpine Model and Temporal Lobe Epilepsy Patients
CNS & Neurological Disorders - Drug Targets