Abstract
In addition to potential future clinical benefits such as reducing adverse drug reactions and optimizing therapeutic efficacy, pharmacogenomic applications promise numerous benefits for the pharmaceutical and biotechnology industries, including decreasing the size and expense of clinical trials and streamlining the drug development process. The application of pharmacogenomics and related technological advances to drug development has prompted various regulatory agencies such as the United States Food and Drug Administration to issue guidance documents and other advisory statements. This article delineates the impact of pharmacogenomic-guided drug development on the regulatory process in the United States including relevant highlights of industry guidance documents and policy statements. Hypothetical vignettes are used to illustrate a number of issues that are challenging to policy makers and the potential impact of pharmacogenomic based drug research and development on the regulatory environment.
Keywords: pharmacogenomics, regulatory policy, food and drug administration, clinical trials, drug development process, federal regulations, pharmaceutical industry
Current Topics in Medicinal Chemistry
Title: The Regulation of Pharmacogenomics-based Drugs and Policy Making
Volume: 4 Issue: 13
Author(s): Amalia M. Issa
Affiliation:
Keywords: pharmacogenomics, regulatory policy, food and drug administration, clinical trials, drug development process, federal regulations, pharmaceutical industry
Abstract: In addition to potential future clinical benefits such as reducing adverse drug reactions and optimizing therapeutic efficacy, pharmacogenomic applications promise numerous benefits for the pharmaceutical and biotechnology industries, including decreasing the size and expense of clinical trials and streamlining the drug development process. The application of pharmacogenomics and related technological advances to drug development has prompted various regulatory agencies such as the United States Food and Drug Administration to issue guidance documents and other advisory statements. This article delineates the impact of pharmacogenomic-guided drug development on the regulatory process in the United States including relevant highlights of industry guidance documents and policy statements. Hypothetical vignettes are used to illustrate a number of issues that are challenging to policy makers and the potential impact of pharmacogenomic based drug research and development on the regulatory environment.
Export Options
About this article
Cite this article as:
Issa M. Amalia, The Regulation of Pharmacogenomics-based Drugs and Policy Making, Current Topics in Medicinal Chemistry 2004; 4 (13) . https://dx.doi.org/10.2174/1568026043387601
DOI https://dx.doi.org/10.2174/1568026043387601 |
Print ISSN 1568-0266 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4294 |
Call for Papers in Thematic Issues
Chemistry Based on Natural Products for Therapeutic Purposes
The development of new pharmaceuticals for a wide range of medical conditions has long relied on the identification of promising natural products (NPs). There are over sixty percent of cancer, infectious illness, and CNS disease medications that include an NP pharmacophore, according to the Food and Drug Administration. Since NP ...read more
Current Trends in Drug Discovery Based on Artificial Intelligence and Computer-Aided Drug Design
Drug development discovery has faced several challenges over the years. In fact, the evolution of classical approaches to modern methods using computational methods, or Computer-Aided Drug Design (CADD), has shown promising and essential results in any drug discovery campaign. Among these methods, molecular docking is one of the most notable ...read more
Drug Discovery in the Age of Artificial Intelligence
In the age of artificial intelligence (AI), we have witnessed a significant boom in AI techniques for drug discovery. AI techniques are increasingly integrated and accelerating the drug discovery process. These developments have not only attracted the attention of academia and industry but also raised important questions regarding the selection ...read more
From Biodiversity to Chemical Diversity: Focus of Flavonoids
Flavonoids are the largest group of polyphenols, plant secondary metabolites arising from the essential aromatic amino acid phenylalanine (or more rarely from tyrosine) via the phenylpropanoid pathway. The flavan nucleus is the basic 15-carbon skeleton of flavonoids (C6-C3-C6), which consists of two phenyl rings (A and B) and a heterocyclic ...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