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Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Assessments of Extractables and Leachables for Pharmaceutical Products - Dennis Jenke
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Dennis Jenke:
Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Assessments of Extractables and Leachables for Pharmaceutical Products - gebunden oder broschiert

ISBN: 0470281766

[SR: 1361469], Hardcover, [EAN: 9780470281765], Wiley-Interscience, Wiley-Interscience, Book, [PU: Wiley-Interscience], Wiley-Interscience, Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development., 265548, Pharmacy, 265544, Pharmacology, 173514, Medical Books, 1000, Subjects, 283155, Books, 689692011, Pharmacy, 689671011, Allied Health Services, 468228, Medicine & Health Sciences, 465600, New, Used & Rental Textbooks, 2349030011, Specialty Boutique, 283155, Books, 689721011, Pharmacology, 689709011, Basic Sciences, 689674011, Medicine, 468228, Medicine & Health Sciences, 465600, New, Used & Rental Textbooks, 2349030011, Specialty Boutique, 283155, Books

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Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development. Technology Technology eBook, Wiley

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Compatibility of Pharmaceutical Solutions and Contact Materials - Jenke, Dennis
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[EAN: 9780470281765], Neubuch, [PU: John Wiley and Sons Ltd], Medical|Pharmacology, This book specifically addresses the safety aspects of compatibility for drugs and their delivery devices and containers. The author deals with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. Num Pages: 380 pages, Illustrations. BIC Classification: MMG; TDCW. Category: (P) Professional & Vocational. Dimension: 245 x 163 x 23. Weight in Grams: 770. . 2009. 1st Edition. Hardcover. . . . . .

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Compatibility of Pharmaceutical Solutions and Contact Materials - gebunden oder broschiert

ISBN: 0470281766

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[EAN: 9780470281765], Neubuch, Medical|Pharmacology, Not Signed; This book specifically addresses the safety aspects of compatibility for drugs and their delivery devices and containers. The author deals with issues such as how the leachables impact safety of a therapeutic product and, more importantly, how one ascertains the magnitude of the impact. The book exa, [PU: Wiley]

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Compatibility of Pharmaceutical Solutions and Contact Materials - Dennis Jenke
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Dennis Jenke:
Compatibility of Pharmaceutical Solutions and Contact Materials - gebunden oder broschiert

2009, ISBN: 9780470281765

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Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Considerations Associated with Extractables and Leachables
Autor:

Jenke, Dennis

Titel:

Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Considerations Associated with Extractables and Leachables

ISBN-Nummer:

Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: * * Pertinent regulations and practical ways to meet guidelines * Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development * Materials characterization and the materials screening process * Component and/or system qualification (illustrated by several case studies) * Performing validation/migration studies and interpreting and reporting the results * Creating a product registration dossier and putting it through regulatory review * Product maintenance (Change Control) from an extractables and leachables perspective * Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.

Detailangaben zum Buch - Compatibility of Pharmaceutical Solutions and Contact Materials: Safety Considerations Associated with Extractables and Leachables


EAN (ISBN-13): 9780470281765
ISBN (ISBN-10): 0470281766
Gebundene Ausgabe
Taschenbuch
Erscheinungsjahr: 2009
Herausgeber: John Wiley & Sons
379 Seiten
Gewicht: 0,658 kg
Sprache: eng/Englisch

Buch in der Datenbank seit 09.05.2009 13:51:15
Buch zuletzt gefunden am 29.06.2017 16:22:36
ISBN/EAN: 0470281766

ISBN - alternative Schreibweisen:
0-470-28176-6, 978-0-470-28176-5


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