Safety Assessment of Pharmaceuticals: Examples of Inadequate Assessments and a Mechanistic Approach to Assuring Adequate Assessment
| Autor: | Gary M. Williams |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Carcinogenicity Tests
040301 veterinary sciences Computer science Decision Making Drug Evaluation Preclinical 04 agricultural and veterinary sciences Cell Biology Pharmacology Toxicology Risk Assessment 030226 pharmacology & pharmacy Pathology and Forensic Medicine 0403 veterinary science Decision points 03 medical and health sciences 0302 clinical medicine Risk analysis (engineering) Benefit analysis New chemical entity Animals Drug Evaluation Humans Carcinogen testing Risk assessment Molecular Biology |
| Zdroj: | Toxicologic Pathology. 25:32-38 |
| ISSN: | 1533-1601 0192-6233 |
| DOI: | 10.1177/019262339702500108 |
| Popis: | For a conventional organic new chemical entity (NCE) being developed as a pharmaceutical, standard regulatory safety assessment studies are required. Early in development, an NCE should undergo a safety/benefit analysis to justify further development. This analysis is made easier and more effective when comprehensive nonclinical data are available. One of the most important aspects of nonclinical toxicologic studies is to provide information on absence of potential carcinogenicity in humans. To avoid human exposures to potentially carcinogenic agents, even in early development of an NCE, the Decision Point Approach to carcinogen testing provides a useful guide to acquisition of mechanistically relevant data for risk assessment. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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