Normal 0 false false false EN-US ZH-CN TH MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin-top:0in; mso-para-margin-right:0in; mso-para-margin-bottom:10.0pt; mso-para-margin-left:0in; line-height:115%; mso-pagination:widow-orphan; font-size:11.0pt; mso-bidi-font-size:14.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;} Because leachables are non-drug-related impurities, there is an increased concern for human risk by inhaling them on a daily basis. Historically, acceptable levels of leachables in OINDP have been set by negotiation with regulatory authorities on a case-by-case basis with no standard guidelines available. Recently, however, safety thresholds for risk assessment of leachables have been developed through a joint effort of scientists from the FDA, academia, and industry. This book describes the development and application of safety thresholds for OINDP. It discusses the best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing readers with practical knowledge about how and why safety thresholds were developed. It also includes an appendix of experimental protocols for laboratory analysis of L & E. This book also illustrates how to apply these concepts and principles to pharmaceutical products beyond OINDP.
