Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
18 - The process of drug development and approval in the United States, the European Union, and Asia
from Section II - Clinical trial methodology
Published online by Cambridge University Press: 05 December 2011
Book contents
- Multiple Sclerosis Therapeutics
- Multiple Sclerosis Therapeutics
- Copyright page
- Contents
- Contributors
- Abbreviations list
- Foreword
- Preface
- Section I Introduction
- Section II Clinical trial methodology
- 6 Measures of neurological impairment and disability in multiple sclerosis
- 7 Assessment of neuropsychological function in multiple sclerosis
- 8 Health-related quality of life assessment in multiple sclerosis
- 9 Measures of acute and chronic lesions visualized by conventional magnetic resonance imaging
- 10 Measures of magnetization transfer
- 11 Measurement of CNS atrophy
- 12 Axonal pathology in patients with multiple sclerosis
- 13 Imaging of gray matter lesions in multiple sclerosis
- 14 Functional imaging in multiple sclerosis
- 15 Diffusion imaging in multiple sclerosis
- 16 The use of MRI in multiple sclerosis clinical trials
- 17 Optical coherence tomography to monitor axonal and neuronal integrity in multiple sclerosis
- 18 The process of drug development and approval in the United States, the European Union, and Asia
- 19 Selection, interpretation, and development of end-points for multiple sclerosis clinical trials
- 20 The challenge of demonstrating long-term benefit of disease-modifying therapies in multiple sclerosis
- 21 The growing need for alternative clinical trial designs for multiple sclerosis
- 22 Ethical considerations in multiple sclerosis clinical trials
- 23 Pharmacogenomics and related discovery-driven approaches in multiple sclerosis
- 24 Neutralizing antibodies directed against biologic agents to treat multiple sclerosis
- Section III Clinical trials of multiple sclerosis therapies
- Section IV Therapy in clinical practice
- Index
- Plate Section
Summary
The process of drug approval in the United States is regulated by the Food and Drug Administration (FDA). The European Union (EU) includes 27 member states, and each member state has its own national regulatory agency responsible for the approval of clinical trial and marketing applications. Clinical studies to support drug development are increasingly becoming more global in nature as trial subjects are recruited from countries throughout the world. The regulatory environment is very dynamic as global health authorities grapple with innovations in science and technology in addition to changes in health policy in their respective countries. Cooperation amongst regulators in regional health authorities has also been advanced through engagement in the International Conference on Harmonization (ICH). The regulations and requirements continue to evolve as further strides are made in the understanding of diseases and the relevant tools, approaches, and therapies for the management of those diseases.
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- Multiple Sclerosis Therapeutics , pp. 225 - 231Publisher: Cambridge University PressPrint publication year: 2011