Think Stop before Going 'Off-Label'
Only after careful and extensive review of all available safety and efficacy data derived from preclinical and clinical trials will a regulatory body approve the licensing of a drug for a specific medical condition ('indication'). Experience with thalidomide, fialuridine and troglitazo...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2004-01-01
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| Series: | Canadian Journal of Gastroenterology |
| Online Access: | http://dx.doi.org/10.1155/2004/571283 |
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| _version_ | 1832559388875816960 |
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| author | Gerald Y Minuk |
| author_facet | Gerald Y Minuk |
| author_sort | Gerald Y Minuk |
| collection | DOAJ |
| description | Only after careful and extensive review of all available safety and efficacy data derived from preclinical and clinical trials will a regulatory body approve the licensing of a drug for a specific medical condition ('indication'). Experience with thalidomide, fialuridine and troglitazone, to name a few, reveal that despite these efforts, the process is not infallible. What then can we expect when a drug is used for a medical condition in which no such review process has been undertaken ('offlabel' use of the drug)? |
| format | Article |
| id | doaj-art-f6e85d2bbab14d109270977992ec4b7e |
| institution | Kabale University |
| issn | 0835-7900 |
| language | English |
| publishDate | 2004-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Canadian Journal of Gastroenterology |
| spelling | doaj-art-f6e85d2bbab14d109270977992ec4b7e2025-02-03T01:30:13ZengWileyCanadian Journal of Gastroenterology0835-79002004-01-0118528728810.1155/2004/571283Think Stop before Going 'Off-Label'Gerald Y MinukOnly after careful and extensive review of all available safety and efficacy data derived from preclinical and clinical trials will a regulatory body approve the licensing of a drug for a specific medical condition ('indication'). Experience with thalidomide, fialuridine and troglitazone, to name a few, reveal that despite these efforts, the process is not infallible. What then can we expect when a drug is used for a medical condition in which no such review process has been undertaken ('offlabel' use of the drug)?http://dx.doi.org/10.1155/2004/571283 |
| spellingShingle | Gerald Y Minuk Think Stop before Going 'Off-Label' Canadian Journal of Gastroenterology |
| title | Think Stop before Going 'Off-Label' |
| title_full | Think Stop before Going 'Off-Label' |
| title_fullStr | Think Stop before Going 'Off-Label' |
| title_full_unstemmed | Think Stop before Going 'Off-Label' |
| title_short | Think Stop before Going 'Off-Label' |
| title_sort | think stop before going off label |
| url | http://dx.doi.org/10.1155/2004/571283 |
| work_keys_str_mv | AT geraldyminuk thinkstopbeforegoingofflabel |