Clinical Research after Drug Approval: What is Needed and What is Not
| Autor: | Marc Buyse, Genevieve Decoster |
|---|---|
| Rok vydání: | 1999 |
| Předmět: |
medicine.medical_specialty
business.industry Clinical study design Public Health Environmental and Occupational Health Alternative medicine Pharmacology (nursing) Pharmacy Professional practice Clinical trial Clinical research Drug Guides Good clinical practice medicine Drug approval Pharmacology (medical) Medical physics business |
| Zdroj: | Drug Information Journal. 33:627-634 |
| ISSN: | 2164-9200 0092-8615 |
| Popis: | This paper delineates the purposes of clinical studies performed with marketed drugs, often called “Phase IV” or “postregistration” trials. The purposes of these trials are outlined, some design issues specific to them are discussed, and the appropriateness of a full implementation of good clinical practice standards in the postregistration setting is questioned. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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