Understanding disposable components
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The new publication will present the safety thresholds and analytical-evaluation thresholds for leachables. The leachable's
analytical-evaluation threshold is derived from the scientifically justified safety-concern threshold and defines the level
above which scientists should begin to identify and assess leachables. The document also will offer advice about applying
the thresholds, taking into consideration factors such as dose duration, patient population, and product-specific characteristics.
As part of its preparation for drafting the document, PQRI performed extraction and analytical testing on various example
materials. The group's results will form the basis for its recommendations for the best approaches for performing controlled
extractions, including rationales for selecting various types of solvents and recommendations for appropriate analytical methodology
in extractables and leachables testing. The document will offer examples to illustrate how PQRI applied its methods to materials
commonly used in parenteral and ophthalmic drug products.
Drugmakers will also find advice about thresholds for known leachables in the final document. The document's authors will
establish categories for known leachables based on safety concern levels, says Paskiet. Additional topics will consider the
best demonstrated practices for studying secondary packages, such as labeling. The document will also help scientists determine
whether simulation studies are appropriate after a material has been fully characterized, says Paskiet. The group currently
is acquiring data about these subjects.
In some respects, parenteral and ophthalmic therapies call for an approach different from that for inhaled drugs, partly because
more of the former products are aqueous-based, and partly because parenteral and ophthalmic drugs can be potent or used for
short durations.
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