Endocrine disruption and the USFDA's Center for Drug Evaluation and Research
| Autor: | Abby Jacobs, J. E. Fisher, James Farrelly, D. Morse, Paul Brown |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Drug
medicine.medical_specialty Pregnancy business.industry Chemistry General Chemical Engineering media_common.quotation_subject Developmental toxicity General Chemistry Pharmacology medicine.disease medicine Endocrine system Relevance (law) In patient Intensive care medicine business Reproductive effects Risk management media_common |
| Zdroj: | Pure and Applied Chemistry. 75:2605-2607 |
| ISSN: | 1365-3075 0033-4545 |
| DOI: | 10.1351/pac200375112605 |
| Popis: | Drugs may have intended or unintended endocrine effects. Drug evaluation may include both in vitro and in vivo evaluations of toxicity and developmental/reproductive effects. After a signal is identified, human relevance is of utmost concern. An integration "tool" that formalizes a weight-of-evidence approach has been developed to assess concern about reproductive/ developmental toxicity to humans. This approach can be used to assess concern about an endocrine disruption signal. A signal alone does not mean a concern for humans. An effect needs to have biologic relevance, and exposure thresholds for effects may exist. Risk/benefit for a particular drug is a clinical decision and may vary by the drug indication. Risk management for an identified concern could include wording in patient communications, tracking distribution or limited distribution, and patient or pregnancy registries. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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