Postmarketing surveillance and the examination of the long-term safety of antiulcer drugs
| Autor: | M.J.S. Langman |
|---|---|
| Rok vydání: | 1993 |
| Předmět: |
Drug
education.field_of_study medicine.medical_specialty Time Factors business.industry Antiulcer drug media_common.quotation_subject Population Gastroenterology Postmarketing surveillance Disease Anti-Ulcer Agents Ranitidine Surgery Clinical trial Product Surveillance Postmarketing Humans Medicine Long term safety Cimetidine business education Intensive care medicine Adverse effect media_common |
| Zdroj: | Baillière's Clinical Gastroenterology. 7:183-190 |
| ISSN: | 0950-3528 |
| Popis: | Before evaluating the evidence for long-term safety of antiulcer drugs, it is useful to consider first the methods available for making judgements about the safety of any drug. At the time of licensing of a drug, information on its safety is available based on pharmacological and toxicological testing in animals, and upon clinical, pharmacological and therapeutic profiles in man. Safety in man will, however, be relatively poorly understood. Clinical trials will have permitted studies of safety and efficacy in groups of one or two thousand patients but these have their inadequacies. Patients chosen for inclusion will satisfy more or less stringent criteria for entry and are likely to represent, apart from the disease under study, a relatively healthy population. By contrast, once a drug is marketed within its licensed indications it will be given to members of a wider-based and often sicker population, with compromised renal, cardiac or other systems, and who are taking other drugs simultaneously. Responses in these, or any other individuals, cannot be predicted with certainty. Postmarketing surveillance is therefore required in order to determine adverse reaction profiles. All such studies are impeded by two main difficulties. Firstly, since such studies by their nature can seldom include randomized groups, comparative data are hard to obtain; secondly, quantitative data are seldom available. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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