Pharmacogenomic drug development raises new challenges for drug regulatory agencies

2005 ◽  
Keyword(s):  
Drug Development ◽  
Regulatory Agencies ◽  
New Challenges ◽  
Drug Regulatory Agencies

scholarly journals Qualification of translational safety biomarkers

2021 ◽  
pp. 153537022110021
Author(s):  
John-Michael Sauer ◽  
Amy C Porter
Keyword(s):  
Skeletal Muscle ◽  
Drug Development ◽  
Vascular Injury ◽  
Validation Studies ◽  
Safety Assessment ◽  
Regulatory Agencies ◽  
Development Studies ◽  
Clinical Validation ◽  
Development Tools ◽  
Important Drug

Safety biomarkers are important drug development tools, both preclinically and clinically. It is a straightforward process to correlate the performance of nonclinical safety biomarkers with histopathology, and ideally, the biomarker is useful in all species commonly used in safety assessment. In clinical validation studies, where histopathology is not feasible, safety biomarkers are compared to the response of standard biomarkers and/or to clinical adjudication. Worldwide, regulatory agencies have put in place processes to qualify biomarkers to provide confidence in the manner of use and interpretation of biomarker data in drug development studies. This paper describes currently qualified safety biomarkers which can be utilized to monitor for nephrotoxicity and cardiotoxicity and ongoing projects to qualify safety biomarkers for liver, skeletal muscle, and vascular injury. In many cases, the development and use of these critical drug development tools is dependent upon partnerships and the precompetitive sharing of data to support qualification efforts.

Health and Safety Strategies in a Changing Europe

1998 ◽  
Vol 28 (2) ◽  
pp. 305-331 ◽  
Author(s):  
David Walters
Keyword(s):  
Public Expenditure ◽  
Health And Safety ◽  
Well Being ◽  
Regulatory Agencies ◽  
The European Union ◽  
The Past ◽  
The Social ◽  
Safety Strategies ◽  
Common Framework ◽  
New Challenges

This article presents a synthesis of some of the more significant findings from two recent surveys on working conditions and national strategies for their improvement in the European Union in the 1990s. As patterns and organization of employment have changed in the past decade, the consequences for health and safety present new challenges for legislators, the social partners, the regulatory agencies, and the specialists. These challenges are only partially met in most European member states. Because of the continued deregulation of employment, reduced public expenditure, and reduced trade union presence, the operation of strategies to implement a common framework of E.U. legislation is limited and often incomplete. This issue must be confronted if systems for promoting the well-being of people at work in Europe are to keep up with the rapidly changing nature of the risks that they face.

scholarly journals Microphysiological Systems: Stakeholder Challenges to Adoption in Drug Development

2021 ◽  
pp. 1-13
Author(s):  
Passley Hargrove-Grimes ◽  
Lucie A. Low ◽  
Danilo A. Tagle
Keyword(s):  
Human Physiology ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
End Users ◽  
Regulatory Agencies ◽  
Functional Level ◽  
Multiple Stakeholder ◽  
Widespread Adoption ◽  
Microphysiological Systems

Microphysiological systems (MPS) or tissue chips/organs-on-chips are novel <i>in vitro</i> models that emulate human physiology at the most basic functional level. In this review, we discuss various hurdles to widespread adoption of MPS technology focusing on issues from multiple stakeholder sectors, e.g., academic MPS developers, commercial suppliers of platforms, the pharmaceutical and biotechnology industries, and regulatory organizations. Broad adoption of MPS technology has thus far been limited by a gap in translation between platform developers, end-users, regulatory agencies, and the pharmaceutical industry. In this brief review, we offer a perspective on the existing barriers and how end-users may help surmount these obstacles to achieve broader adoption of MPS technology.

Pharmacovigilance

2013 ◽  
pp. 1453-1473
Author(s):  
Jimmy Jose
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Drug Safety ◽  
Health Care Professionals ◽  
Regulatory Agencies ◽  
Major Influence ◽  
Design Development ◽  
Hospital Perspective ◽  
Basic Concepts ◽  
Drug Regulatory Agencies

Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. It is important to understand the basic concepts related to Adverse Drug Reactions (ADRs): epidemiology, classification, predisposing factors, evaluation parameters, and surveillance methods. Pharmacovigilance is defined as the science and activities relating to the detection, evaluation, understanding, and prevention of ADRs or any other drug-related problems. It involves patients, medical professionals, the pharmaceutical industry, drug regulatory agencies, and academic scientists. Pharmacoinformatics, the application of information technology with regard to the drug design, development, and drug use has played a major role in the appropriate implementation of pharmacovigilance at industry, regulatory, and hospital levels. The functioning of international regulatory agencies and drug safety departments of pharmaceutical industries has been greatly influenced by pharmacoinformatics. Pharmacoinformatics has changed the way in which health care is practiced. Modern information technology can be used by health care professionals for various purposes and, thereby, make a substantial contribution to optimize the quality of medication use in institutions with due importance of safety. Pharmacoinformatics has a major influence in the development of pharmacogenetics and its individual applications including improving drug safety. Pharmacoinformatics will play a major role in the future development and practice of pharmacovigilance. The present chapter is aimed at providing the readers an insight into the importance and basic concepts of pharmacovigilance, and the process involved in it. Application of pharmacoinformatics in improving drug safety at various levels from an industry, regulatory and hospital perspective is discussed.

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