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
-
Extracellular Targeting of Synthetic Therapeutic Nucleic Acid Formulations
Current Gene Therapy MDM2-p53 Interaction in Paediatric Solid Tumours: Preclinical Rationale, Biomarkers and Resistance
Current Drug Targets Possible Involvement of Programmed Cell Death Pathways in the Neuroprotective Action of Polyphenols
Current Alzheimer Research Anti-Apoptotic Actions of Insulin-Like Growth Factors: Lessons from Development and Implications in Neoplastic Cell Transformation
Current Pharmaceutical Design An Overview of the Chemistry and Pharmacological Potentials of Furanones Skeletons
Current Organic Chemistry Anti-Proliferative Activity of Standardized Methanol Extract of Coscinium fenestratum and Its Major Constituent, Berberine, Against Nasopharyngeal Carcinoma Cells
The Natural Products Journal Mitochondrial Respiration in the Platelets of Patients with Alzheimer’s Disease
Current Alzheimer Research Management of the Menopausal Disturbances and Oxidative Stress
Current Pharmaceutical Design MicroRNAs in the Pathobiology of Multiple Myeloma
Current Cancer Drug Targets Viral Vectors in Cancer Immunotherapy: Which Vector for Which Strategy?
Current Gene Therapy On the Interaction of β-Amyloid Peptides and α7-Nicotinic Acetylcholine Receptors in Alzheimer’s Disease
Current Alzheimer Research The Problem of Amino Acid Complementarity and Antisense Peptides
Current Protein & Peptide Science 1, 2-Benzisoxazole: A Privileged Structure with a Potential for Polypharmacology
Current Pharmaceutical Design Vasorelaxation Caused by Cannabinoids: Mechanisms in Different Vascular Beds
Current Vascular Pharmacology Bioinformatics Approach to BDNF and BDNF-Related Disorders
Current Neuropharmacology Gas1 is a Pleiotropic Regulator of Cellular Functions: from Embryonic Development to Molecular Actions in Cancer Gene Therapy
Mini-Reviews in Medicinal Chemistry Microdissection and the Study of Cancer Pathways
Current Molecular Medicine Agonists of the Tissue-Protective Erythropoietin Receptor in the Treatment of Parkinson’s Disease
Current Topics in Medicinal Chemistry Kinases as Targets for Parkinson's Disease: From Genetics to Therapy
CNS & Neurological Disorders - Drug Targets Chips for Brains
Current Genomics