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010 a| 2011026193;

020 a| 9780470173657 (hardback);

020 a| 0470173653 (hardback);

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245 00 a| Leachables and extractables handbookh| [electronic resource] :b| safety evaluation, qualification, and best practices applied to inhalation drug products /c| edited by Douglas J. Ball ... [et al.].;

260 a| Hoboken, N.J. :b| John Wiley & Sons,;

300 a| xvi, 683 p. :b| ill. ;c| 25 cm.;

504 a| Includes bibliographical references.;

505 8 a| Machine generated contents note: Acknowledgements.Dedication.Preface.Part I. Development of Safety Thresholds, Safety Evaluation, and Qualification of Extractables and Leachable in Orally Inhaled Nasal Drug Products. Overview of Leachables and Extractables in Orally Inhaled and Nasal Products / Douglas J. Ball, Daniel L. Norwood, Lee M. Nagao -- A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems / Dennis Jenke -- Concepts and Application of Safety Thresholds in Drug Development / David Jacobson-Kram and Ronald D. Snyder -- The Development of Safety Thresholds for Leachables on Orally Inhaled and Nasal Drug Products / W. Mark Vogel -- The Analytical Evaluation Thresholds (AET) and its Relationship to Safety Thresholds / Daniel L. Norwood, James O. Mullis, Scott Pennino -- Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective / David Alexander and James Blanchard -- The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists / Cheryl L. M. Stults, Ronald Wolff, Douglas J. Ball -- Use of Safety Thresolds in the Pharmaceutical Development Process for OINDP : US Regulatory Perspectives / Timothy J. McGovern -- The Application of Safety Thresholds to Quality Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products : A Regulatory Perspective / Kumudini Nicholas -- Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products / Dan Norwood, Cheryl Stults and Lee Nagao -- Chemical and Physical Attributes of Plastics and Elastomers : Impact on the Extractables Profile of Container Closure Systems / Michael A Ruberto and Diane Paskiet -- Pharmaceutical Container Closure System - Selection & Qualification of Materials / Douglas J. Ball, William P. Beierschmitt, and Arthur J. Shaw -- Analytical Techniques for Identification of Extractables and Leachables / Dan Norwood ... [et al.] -- Extractables - The Controlled Extraction Study / Thomas N. Feinberg ... [et al.] -- Extractables - Case Study of a Sulfur Elastomer / Daniel L. Norwood ... [et al.] -- Extractables - Case Study of a Polypropylene / Diane Paskiet, Laura Stubbs, and Alan D. Hendricker -- Leachables - Analytical Leachables Studies / Andrew D. Feilden and Andy Rignall -- Development and Optimization of Methods for Routine Testing / Cheryl L. Stults and Jason M. Creasey -- Critical Component Quality Control and Specification Strategies / Terrence Tougas, Suzette Roan, and Barbara Falco -- Inorganic Leachables / Diane Paskiet ... [et al.] -- Foreign Particulate Matter / James Coleman ... [et al.].;

506 a| Available only to authorized users.;

520 a| "Because leachables are non-drug-related impurities, there are increased concerns regarding the risks of inhaling them on a daily basis. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed. This book also illustrates how to apply these concepts and principles to products beyond OINDP, and includes an appendix of experimental protocols for laboratory analysis"--Provided by publisher.;

538 a| Mode of access: World Wide Web;

650 12 a| Drug Delivery Systemsx| standards.=| ^A1337113;

650 12 a| Nebulizers and Vaporizersx| standards.=| ^A940456;

650 22 a| Drug Contaminationx| prevention & control.=| ^A934005;

650 22 a| Drug Packagingx| standards.=| ^A1004814;

650 22 a| Pharmaceutical Preparationsx| administration & dosage.=| ^A931127;

650 22 a| Risk Assessmentx| standards.=| ^A1204780;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Ball, Douglas J.?| UNAUTHORIZED;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=818476;

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Leachables and extractables handbook safety evaluation, qualification, and best practices applied to inhalation drug products / edited by Douglas J. Ball ... [et al.].

Other author	Ball, Douglas J.
Format	Electronic
Publication Info	Hoboken, N.J. : John Wiley & Sons,
Description	xvi, 683 p. : ill. ; 25 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	Drug Delivery Systems--standards. Nebulizers and Vaporizers--standards. Drug Contamination--prevention & control. Drug Packaging--standards. Pharmaceutical Preparations--administration & dosage. Risk Assessment--standards.

Contents	Machine generated contents note: Acknowledgements.Dedication.Preface.Part I. Development of Safety Thresholds, Safety Evaluation, and Qualification of Extractables and Leachable in Orally Inhaled Nasal Drug Products. Overview of Leachables and Extractables in Orally Inhaled and Nasal Products / Douglas J. Ball, Daniel L. Norwood, Lee M. Nagao -- A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems / Dennis Jenke -- Concepts and Application of Safety Thresholds in Drug Development / David Jacobson-Kram and Ronald D. Snyder -- The Development of Safety Thresholds for Leachables on Orally Inhaled and Nasal Drug Products / W. Mark Vogel -- The Analytical Evaluation Thresholds (AET) and its Relationship to Safety Thresholds / Daniel L. Norwood, James O. Mullis, Scott Pennino -- Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective / David Alexander and James Blanchard -- The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists / Cheryl L. M. Stults, Ronald Wolff, Douglas J. Ball -- Use of Safety Thresolds in the Pharmaceutical Development Process for OINDP : US Regulatory Perspectives / Timothy J. McGovern -- The Application of Safety Thresholds to Quality Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products : A Regulatory Perspective / Kumudini Nicholas -- Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products / Dan Norwood, Cheryl Stults and Lee Nagao -- Chemical and Physical Attributes of Plastics and Elastomers : Impact on the Extractables Profile of Container Closure Systems / Michael A Ruberto and Diane Paskiet -- Pharmaceutical Container Closure System - Selection & Qualification of Materials / Douglas J. Ball, William P. Beierschmitt, and Arthur J. Shaw -- Analytical Techniques for Identification of Extractables and Leachables / Dan Norwood ... [et al.] -- Extractables - The Controlled Extraction Study / Thomas N. Feinberg ... [et al.] -- Extractables - Case Study of a Sulfur Elastomer / Daniel L. Norwood ... [et al.] -- Extractables - Case Study of a Polypropylene / Diane Paskiet, Laura Stubbs, and Alan D. Hendricker -- Leachables - Analytical Leachables Studies / Andrew D. Feilden and Andy Rignall -- Development and Optimization of Methods for Routine Testing / Cheryl L. Stults and Jason M. Creasey -- Critical Component Quality Control and Specification Strategies / Terrence Tougas, Suzette Roan, and Barbara Falco -- Inorganic Leachables / Diane Paskiet ... [et al.] -- Foreign Particulate Matter / James Coleman ... [et al.].
Abstract	"Because leachables are non-drug-related impurities, there are increased concerns regarding the risks of inhaling them on a daily basis. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed. This book also illustrates how to apply these concepts and principles to products beyond OINDP, and includes an appendix of experimental protocols for laboratory analysis"--Provided by publisher.
Bibliography note	Includes bibliographical references.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2011026193
ISBN	9780470173657 (hardback)
ISBN	0470173653 (hardback)

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