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Data from regulator...
Data from regulatory studies: What do they tell? What don't they tell?
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- Ben-Menachem, Elinor, 1945 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för klinisk neurovetenskap, Sektionen för kliniska nervsjukdomar,Institute of Clinical Neurosciences, Section of Neurological Diseases
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(creator_code:org_t)
- Hindawi Limited, 2005
- 2005
- English.
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In: Acta neurologica Scandinavica. Supplementum. - : Hindawi Limited. - 0065-1427 .- 0001-6314 .- 1600-0404. ; 181, s. 21-5
- Related links:
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https://gup.ub.gu.se...
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Abstract
Subject headings
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- Phase III studies of antiepileptic drugs (AEDs) are specifically designed to satisfy strict regulatory criteria. As they are conducted in protocol-restricted patient populations over short treatment periods and employ fixed study designs and dosing schedules, they are not fully representative of 'real-life' clinical practice. Therefore, in order to provide an overall assessment of clinical performance, regulatory studies must be backed up by post-marketing clinical experience. Phase IV studies provide information on a drug's performance in a setting more closely representing real clinical practice, with broader patient populations and a more flexible approach to individual treatment. Prospective long-term studies allow the determination of efficacy and safety (and cost-effectiveness) over extended treatment periods; these studies and audit data provide a means of assessing idiosyncratic side effects, unusual interactions and the effects of an AED in rare patient groups. By complementing regulatory evidence with real-life clinical experience, a comprehensive assessment of the risks and benefits of an AED can be made.
Keyword
- Adverse Drug Reaction Reporting Systems
- Anticonvulsants
- adverse effects
- therapeutic use
- Clinical Trials
- Phase III as Topic
- legislation & jurisprudence
- Clinical Trials
- Phase IV as Topic
- legislation & jurisprudence
- Drug Approval
- legislation & jurisprudence
- Drug Interactions
- Epilepsy
- drug therapy
- Follow-Up Studies
- Humans
- Product Surveillance
- Postmarketing
- Prospective Studies
- Risk Assessment
- Treatment Outcome
- United States
Publication and Content Type
- ref (subject category)
- art (subject category)
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