A COMPARISON OF THE U.S. EPA FIFRA GLP STANDARDS WITH THE U.S. FDA GLP STANDARDS FOR NONCLINICAL LABORATORY STUDIES
| Autor: | Kendy L. Keatley |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
Drug Industry
Quality Assurance Health Care United States Food and Drug Administration Scientific practice Drug Evaluation Preclinical Guidelines as Topic General Medicine Computer security computer.software_genre United States Food and drug administration Benchmarking Documentation Audit trail Research Design Law Animals Humans Registries Business United States Environmental Protection Agency Laboratories Drug industry computer Facility Regulation and Control |
| Zdroj: | Quality Assurance. 7:147-154 |
| ISSN: | 1521-0677 1052-9411 |
| DOI: | 10.1080/105294100750035125 |
| Popis: | In the early 1980's both the Environmental Protection Agency and the Food and Drug Administration were receiving studies on the products that they regulate that were unscientifically sound, some even being fraudulent. Studies were being submitted that had not been done under sound scientific practice; data were missing; necessary documentation to reconstruct the study, also known as an audit trail, was not in place, it was this evidence that lead to the Good Laboratory Practice Standards (GLPs) being codified and becoming regulation. The GLPs were meant to assure that studies submitted to the agencies for the registration of products for which they were responsible would protect the environment, and, the safety and health of the public. |
| Databáze: | OpenAIRE |
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