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OGD pharmacologists outline safety thresholds and surrogate selection
Summary
Vince Crowley of OGD described how reviewers set safety concern thresholds, select surrogates when compound-specific data are missing, and weigh structural and physicochemical similarity when grouping leachables.
Vince Crowley explained that OGD's review of leachables centers on predefined thresholds and product context, and he described which toxicity endpoints reviewers consider when a compound exceeds thresholds. He said compounds identified above thresholds should be reported by CAS number or chemical structure and that safety justifications must include immunogenicity, general toxicity, and local toxicity relevant to exposure and route.
"For most routes, that's 1.5, micrograms per day for chronic used drug products, and for shorter use, products, it's 5 micrograms per day," Crowley said, adding that more sensitive routes such as ophthalmic or intrathecal administration may warrant lower thresholds. He also discussed read‑across surrogate selection, advising that surrogates be structurally similar, have similar metabolism, and comparable physicochemical properties.
