Publications by authors named "William A Hawkins"
Article Synopsis
- Permitted Daily Exposure Limits (PDEs) for Active Pharmaceutical Ingredients (APIs) are crucial for managing cross-contamination in shared manufacturing facilities, but companies must set their own limits due to the absence of official lists.
- Despite the existence of general guidelines, variations in PDE settings among companies are acceptable within a defined range.
- A study comparing PDEs for five marketed APIs demonstrated that the variations are generally minor (under 10-fold), with notable differences primarily for morphine, highlighting factors such as data availability and company policies that influence these limits.
Fluid stewardship targets optimal fluid management to improve patient outcomes. Intravenous (IV) medications, flushes, and blood products, collectively referred to as hidden fluids, contribute to fluid intake in the intensive care unit (ICU). The impact of specific IV medications on fluid intake is unknown.
View Article and Find Full Text PDFCorrigendum to a cross-industry collaboration to assess if acute toxicity (Q)SAR models are fit-for-purpose for GHS classification and labelling. Regulatory toxicology and pharmacology (2021) 104843.
Regul Toxicol Pharmacol
June 2022
This study assesses whether currently available acute oral toxicity (AOT) in silico models, provided by the widely employed Leadscope software, are fit-for-purpose for categorization and labelling of chemicals. As part of this study, a large data set of proprietary and marketed compounds from multiple companies (pharmaceutical, plant protection products, and other chemical industries) was assembled to assess the models' performance. The absolute percentage of correct or more conservative predictions, based on a comparison of experimental and predicted GHS categories, was approximately 95%, after excluding a small percentage of inconclusive (indeterminate or out of domain) predictions.
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