Considerations for setting occupational exposure limits for novel pharmaceutical modalities
نویسندگان
چکیده
منابع مشابه
Setting 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 کاملSetting 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 کاملStrategies for setting occupational exposure limits for particles.
To set occupational exposure limits (OELs) for aerosol particles, dusts, or chemicals, one has to evaluate whether mechanistic considerations permit identification of a no observed effect level (NOEL). In the case of carcinogenic effects, this can be assumed if no genotoxicity is involved, and exposure is considered safe if it does not exceed the NOEL. If tumor induction is associated with geno...
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...
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ژورنال
عنوان ژورنال: Regulatory Toxicology and Pharmacology
سال: 2020
ISSN: 0273-2300
DOI: 10.1016/j.yrtph.2020.104813