Setting Occupational Exposure Limits for Genotoxic Substances in the Pharmaceutical Industry
نویسندگان
چکیده
منابع مشابه
Setting Occupational Exposure Limits for Genotoxic Substances in the Pharmaceutical Industry.
In the pharmaceutical industry, genotoxic drug substances are developed for life-threatening indications such as cancer. Healthy employees handle these substances during research, development, and manufacturing; therefore, safe handling of genotoxic substances is essential. When an adequate preclinical dataset is available, a risk-based decision related to exposure controls for manufacturing is...
متن کاملDeveloping Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances
Acceptable surface limits (ASLs) are developed in order to establish a quantitative measure for the potential risk from exposure by dermal contact. In the pharmaceuticals industry, ASLs are used for protection against active pharmaceutical ingredients that are known to cause pharmacological or toxicological effects. An ASL can be used, together with appropriate analytical methods and industrial...
متن کاملOccupational exposure limits for therapeutic substances.
Few therapeutic substances have occupational exposure limits (OELs) set by regulatory bodies and reliance is often placed on in-house OELs derived from a formula based on the therapeutic dose. This mode of derivation relies on assumptions about pharmacokinetics, pharmacodynamics and risk acceptability which might not be soundly based for occupational health purposes. Pharmacodynamic evidence sh...
متن کاملSetting Occupational Exposure Limits: Are
Setting limits for safe exposure to toxic agents in the workplace is a complex process involving science, law, and policy. Development and use of occupational exposure limits (OELs) transcends national interests and international borders. Even though OELs have a lengthy history, and they form the cornerstone of most occupational risk assessment and risk management plans, their effectiveness in ...
متن کاملSetting occupational exposure limits for unstudied pharmaceutical intermediates using an in vitro parallelogram approach.
Occupational exposure limits for unstudied pharmaceutical synthetic intermediates are often established under the assumption that penultimate and near-ultimate intermediates have the same structure-activity and dose-response as the ultimate active pharmaceutical ingredient (API). This is seldom the case because moieties that render biological activity to the API are often protected or modified ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Toxicological Sciences
سال: 2016
ISSN: 1096-6080,1096-0929
DOI: 10.1093/toxsci/kfw028