Framework for sensitization assessment of extractables and leachables in pharmaceuticals
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DOI: 10.1080/10408444.2022.2065966
Abstract: Abstract During the toxicological assessment of extractables and leachables in drug products, localized hazards such as irritation or sensitization may be identified. Typically, because of the low concentration at which leachables occur in pharmaceuticals, irritation… read more here.
Keywords: assessment; sensitization; sensitization assessment; framework sensitization ... See more keywords
Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
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DOI: 10.5731/pdajpst.2019.011379
Abstract: Prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and… read more here.
Keywords: leachables program; biotechnology; program; program evaluations ... See more keywords
Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes.
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DOI: 10.5731/pdajpst.2021.012671
Abstract: Drug products and medical devices can contain impurities, termed leachables, which could produce an adverse patient health effect during clinical use. To establish patient exposure to leachables, drug products, packaging or manufacturing system extracts are… read more here.
Keywords: standardization; screening methods; risk assessment; organic extractables ... See more keywords
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)
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DOI: 10.5731/pdajpst.2021.012693
Abstract: The threshold of toxicological concern (TTC), i.e., the dose of a compound lacking sufficient experimental toxicity data that is unlikely to result in an adverse health effect in humans, is important for evaluating extractables and… read more here.
Keywords: ttc values; extractables leachables; toxicological concern; non mutagenic ... See more keywords
Principles for Management of Extractables and Leachables in Ophthalmic Drug Products.
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DOI: 10.5731/pdajpst.2022.012744
Abstract: Ophthalmic solutions and suspensions have long been classified into a high risk category with respect to concerns over extractables and leachables (E&L), though specific guidance on the management of leachables in these products is generally… read more here.
Keywords: safety; drug products; extractables leachables; ophthalmic drug ... See more keywords