IPAC-RS

Leachables and Extractables (L&E) Development Paradigm Knowledge Network

Our Working Group is concentrated on consideration of how Quality by Design and ICH tripartite guideline concepts can be practically integrated with traditional approaches for management of leachables and extractables.

Activities include: assessing injection molding and elastomer manufacturing processes; developing molding design of experiments for plastics; conducting design of experiment to generate plastic parts; and generating extractables information from design of experiment parts and perform statistical study on extractables profiles to assess the effect of identified critical molding parameters on peak number and extractables levels.

Publications

An IPAC-RS Update: Delivery Systems, L&E and GRRO

By Working Group: Global Regulatory Review Outreach (GRRO). By Working Group: Leachables and Extractables (L&E) Development Paradigm Knowledge Network. By Working Group: Device. Ilse Peterson, Svetlana Lyapustina, and Lee Nagao Article, Inhalation (published)

Leachables and Extractables Handbook

is available at: IPAC-RS. By Working Group: Leachables and Extractables (L&E) Development Paradigm Knowledge Network. Douglas J. Ball (Editor), Daniel L. Norwood (Editor), Cheryl L. M. Stults (Editor), Lee M. Nagao (Editor) Book, (published)

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