PDE/ADE & OEL/OEB Reports

Health-based limits underpin both cross-contamination control and worker safety, and regulators expect them to be derived and documented by qualified toxicologists rather than estimated by rule of thumb. PharmExpert provides Permitted Daily Exposure (PDE)/Acceptable Daily Exposure (ADE), Occupational Exposure Limit (OEL) and Occupational Exposure Band (OEB) reports for your compounds.

Our toxicologists review the available pharmacological and toxicological data for each compound — including potency, mechanism, and the most sensitive relevant endpoint — and derive limits with a transparent, defensible rationale consistent with the EMA HBEL guideline. Where data are limited, we apply scientifically justified approaches and clearly state assumptions.

These values do real work downstream. PDE/ADE figures feed directly into health-based MACO acceptance limits for cleaning validation and into shared- and multi-product-facility risk assessments, while OEL/OEB values drive occupational-safety controls, containment design and handling procedures.

Each report is a qualified-toxicologist monograph with full references and rationale, suitable for inspection and for inclusion in your cleaning-validation and EHS documentation. We also review and update limits as new data emerge, so your control limits stay current and defensible across the product lifecycle.