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Recommendations for Standards Regarding Preclinical Neuroprotective and Restorative Drug Development
- Source :
- Europe PubMed Central
- Publication Year :
- 1999
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 1999.
-
Abstract
- Abstract —The plethora of failed clinical trials with neuroprotective drugs for acute ischemic stroke have raised justifiable concerns about how best to proceed for the future development of such interventions. Preclinical testing of neuroprotective drugs is an important aspect of assessing their therapeutic potential, but guidelines concerning how to perform preclinical development of purported neuroprotective drugs for acute ischemic stroke are lacking. This conference of academicians and industry representatives was convened to suggest such guidelines for the preclinical evaluation of neuroprotective drugs and to recommend to potential clinical investigators the data they should review to reassure themselves that a particular neuroprotective drug has a reasonable chance to succeed in an appropriately designed clinical trial. Without rigorous, robust, and detailed preclinical evaluation, it is unlikely that novel neuroprotective drugs will prove to be effective when tested in large, time-consuming, and expensive clinical trials. Additionally, similar recommendations are provided for drugs with the potential to enhance recovery after acute ischemic stroke, a burgeoning new field with great potential but little currently available data. The suggestions contained in this document are meant to serve as overall guidelines that must be adapted to the individual characteristics related to particular drugs and their preclinical and clinical development needs.
- Subjects :
- Primates
medicine.medical_specialty
Remission, Spontaneous
Drug Evaluation, Preclinical
Alternative medicine
Psychological intervention
Guidelines as Topic
Neuroprotection
Neuroprotective drug
Sex Factors
Neuroprotective Drugs
Outcome Assessment, Health Care
Animals
Medicine
Intensive care medicine
Acute ischemic stroke
Advanced and Specialized Nursing
business.industry
Enzymes
Rats
Stroke
Clinical trial
Disease Models, Animal
Drug Combinations
Neuroprotective Agents
Drug development
Neurology (clinical)
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- ISSN :
- 15244628 and 00392499
- Volume :
- 30
- Database :
- OpenAIRE
- Journal :
- Stroke
- Accession number :
- edsair.doi.dedup.....4530c54684cad71c0a20a5e4109a3b1e