عنوان

Leachables and extractables handbook :safety evaluation, qualification, and best practices applied to inhalation drug products

Standard Number

electronic

Title Proper

Leachables and extractables handbook :safety evaluation, qualification, and best practices applied to inhalation drug products

Place of Publication, Distribution, etc.

Hoboken, N.J.

Name of Publisher, Distributor, etc.

John Wiley & Sons

Date of Publication, Distribution, etc.

2012

Specific Material Designation and Extent of Item

xvi, 683 p. : ill. ; 25 cm.

Text of Note

Includes bibliographical references

Text of Note

Douglas J. Ball ... ]et al.[

Text of Note

R

Text of Note

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.[

Entry Element

standards ، Drug Delivery Systems

Entry Element

standards ، Nebulizers and Vaporizers

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prevention & control ، Drug Contamination

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standards ، Drug Packaging

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administration & dosage ، Pharmaceutical Preparations

Entry Element

standards ، Risk Assessment

Class number

Relator Code

TI

AU Ball, Douglas J