Publications by authors named "Elisa Schulze"
Regul Toxicol Pharmacol
June 2024
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.
