{"product_id":"leachables-and-extractables-handbook-9780470173657","title":"Leachables and Extractables Handbook","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eA practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products\u003c\/p\u003e \u003cp\u003ePackaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)?such as metered dose inhalers, dry powder inhalers, and nasal sprays?pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceu\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e“However, since this handbook provides clear, relevant information across both toxicology and pharmaceutical analysis\/development, it is probably most useful for practicing toxicologists or chemists, providing both a detailed reference to dip into and a means of better understanding the requirements and contributions of colleagues working in the other discipline.”  (\u003ci\u003eBritish Toxicology Society\u003c\/i\u003e, 1 July 2013)\u003c\/p\u003e “However, the book is extremely well written and is a compelling read.  The book accomplishes its goal to provide a state of the art review with respect to mercury . . . The book serves as an excellent educational resource.”  (\u003ci\u003eInternational Journal of Toxicology\u003c\/i\u003e, 31 May 2012)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eAcknowledgements.  \u003cp\u003eDedication.\u003c\/p\u003e \u003cp\u003ePreface.\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I. Development of Safety Thresholds, Safety Evaluation, and Qualification of Extractables and Leachable in Orally Inhaled Nasal Drug Products.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1. Chapter 1. Overview of Leachables and Extractables in Orally Inhaled and Nasal Products (\u003ci\u003eDouglas J. Ball, Daniel L. Norwood, Lee M. Nagao\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e2. Chapter 2. A General Overview of the Suitability for Intended Use Requirements for Materials Used in Pharmaceutical Systems (\u003ci\u003eDennis Jenke\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e3. Chapter 3. Concepts and Application of Safety Thresholds in Drug Development (\u003ci\u003eDavid Jacobson-Kram and Ronald D. Snyder\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e4. Chapter 4. The Development of Safety Thresholds for Leachables on Orally Inhaled and Nasal Drug Products (\u003ci\u003eW. Mark Vogel\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e5. Chapter 5. The Analytical Evaluation Thresholds (AET) and its Relationship to Safety Thresholds (\u003ci\u003eDaniel L. Norwood, James O. Mullis, Scott Pennino\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e6. Chapter 6. Safety Thresholds in the Pharmaceutical Development Process for OINDP: An Industry Perspective (\u003ci\u003eDavid Alexander and James Blanchard\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e7. Chapter 7. The Chemistry and Toxicology Partnership: Extractables and Leachables Information Sharing Among the Chemists and Toxicologists (\u003ci\u003eCheryl L. M. Stults, Ronald Wolff, Douglas J. Ball\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e8. Chapter 8. Use of Safety Thresolds in the Pharmaceutical Development Process for OINDP: US Regulatory Perspectives (\u003ci\u003eTimothy J. McGovern\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e9. Chapter 9. The Application of Safety Thresholds to Quality Leachables from Plastic Container Closure Systems Intended for Pharmaceutical Products: A Regulatory Perspective (\u003ci\u003eKumudini Nicholas\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart 2. Best Practices for Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10. Chapter 10. Analytical Best Practices for the Evaluation and Management of Extractables and Leachables in Orally Inhaled and Nasal Drug Products (\u003ci\u003eDan Norwood, Cheryl Stults and Lee Nagao\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e11. Chapter 11. Chemical and Physical Attributes of Plastics and Elastomers: Impact on the Extractables Profile of Container Closure Systems (\u003ci\u003eMichael A Ruberto and Diane Paskiet\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e12. Chapter 12. Pharmaceutical Container Closure System – Selection \u0026amp; Qualification of Materials (\u003ci\u003eDouglas J. Ball, William P. Beierschmitt, and Arthur J. Shaw\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e13. Chapter 13. Analytical Techniques for Identification of Extractables and Leachables (\u003ci\u003eDan Norwood, Thomas N. Feinberg, James O. Mullis, and Scott Pennino\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e14. Chapter 14. Extractables – The Controlled Extraction Study (\u003ci\u003eThomas N. Feinberg, Daniel L. Norwood, Alice T. Granger, and Dennis Jenke\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e15. Chapter 15. Extractables – Case Study of a Sulfur Elastomer (\u003ci\u003eDaniel L. Norwood, Fenghe Qiu, James Coleman, James O. Mullis, Alice T. Granger, Keith McKellop, Michelle Raikes, John Robson, David Olenski, John Hand, Sr., Melinda K. Munos, Tianjing Deng, Xiaochun Yu, Derek Wood, Shauang Li, Song Klapoetke and Xiaoya Ding\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e16. Chapter 16. Extractables – Case Study of a Polypropylene (\u003ci\u003eDiane Paskiet, Laura Stubbs, and Alan D. Hendricker\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e17. Chapter 17. Leachables – Analytical Leachables Studies (\u003ci\u003eAndrew D. Feilden and Andy Rignall\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e18. Chapter 18. Development and Optimization of Methods for Routine Testing (\u003ci\u003eCheryl L. Stults and Jason M. Creasey\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e19. Chapter 19. Critical Component Quality Control and Specification Strategies (\u003ci\u003eTerrence Tougas, Suzette Roan, and Barbara Falco\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e20. Chapter 20. Inorganic Leachables (\u003ci\u003eDiane Paskiet, Ernest L. Lippert, Brian D. Mitchell, and Diego Zurbriggen\u003c\/i\u003e).\u003c\/p\u003e \u003cp\u003e21. Chapter 21. Foreign Particulate Matter (\u003ci\u003eJames Coleman, John A. Robson, John A. Smoliga, and Cornelia B. Field\u003c\/i\u003e). \u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":50577349017943,"sku":"9780470173657","price":108.86,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470173657.jpg?v=1746094996","url":"https:\/\/bookcurl.com\/products\/leachables-and-extractables-handbook-9780470173657","provider":"Book Curl","version":"1.0","type":"link"}