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010 a| 2022053545;

020 a| 9781032291628q| (hardback);

020 a| 9781032291635q| (paperback);

020 z| 9781003300298q| (ebook);

035 a| (WaSeSS)ssj0002815919;

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050 00 a| RM301.25;

060 00 a| QV 778;

082 00 a| 615.1/92| 23/eng/20230429;

245 04 a| The combination products handbookh| [electronic resource] :b| a practical guide /c| edited by Susan W. Neadle.;

250 a| First edition.;

260 a| Boca Raton :b| CRC Press,c| 2023.;

263 a| 2305;

300 a| pages cm;

504 a| Includes bibliographical references and index.;

505 0 a| What is a Combination Product? / Susan Neadle -- Regulatory Strategies / Suzette Roan -- cGMPs / Susan Neadle and Mike Wallenstein -- Integrated Development / Susan Neadle -- Risk Management / Susan Neadle, Richard Wedge, and Edwin Bills -- Human Factors Engineering in the Design, Development and Lifecycle of Combination Products / Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble -- Lifecycle Management: Design Transfer through Post Market / Susan Neadle and Khaudeja Bano -- Best Practices and Considerations for Combination Products Inspection Readiness / Susan Neadle -- US Combination Product Inspections / Kim Trautman -- Supplier Quality Considerations / Fran DeGrazio and Meera Raghuram -- Analytical Testing Considerations / Daniel Bantz and Jennifer Riter -- Biological Products Considerations / Manfred Maeder -- Connected Health / Ryan McGowan -- Evolving Global Regulatory Landscape / Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle.;

506 a| Available only to authorized users.;

520 a| "Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation"--c| Provided by publisher.;

538 a| Mode of access: World Wide Web;

650 12 a| Equipment and Suppliesx| standards=| ^A923321;

650 12 a| Technology, Pharmaceuticalx| standards=| ^A941603;

650 22 a| Pharmaceutical Preparationsx| standards=| ^A964325;

650 22 a| Biological Productsx| standards=| ^A923201;

650 22 a| Equipment Design=| ^A930934;

650 22 a| Drug Design=| ^A925973;

650 22 a| Device Approval=| ^A941286;

650 22 a| Drug Approval=| ^A928241;

650 22 a| Drug Industryx| legislation & jurisprudence=| ^A1202481;

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

700 1 a| Neadle, Susan W.?| UNAUTHORIZED;

856 40 z| Full text available from Taylor & Francis eBooksu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Fwww.taylorfrancis.com%2Fbooks%2F9781003300298;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6660483-1001l| JNETm| JOYNERr| Ys| Yt| JNESSBKu| 12/18/2025x| EBOOKz| JERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6660483-2001l| HSLELECm| HSLr| Ys| Yt| HEBKu| 12/18/2025x| EBOOKz| HERESOURCE;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6660483-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 12/18/2025x| EBOOKz| JERESOURCE;

The combination products handbook a practical guide / edited by Susan W. Neadle.

Other author	Neadle, Susan W.
Format	Electronic
Edition	First edition.
Publication Info	Boca Raton : CRC Press, 2023.
Description	pages cm
Supplemental Content	Full text available from Taylor & Francis eBooks
Subjects	Equipment and Supplies--standards. Technology, Pharmaceutical--standards. Pharmaceutical Preparations--standards. Biological Products--standards. Equipment Design Drug Design Device Approval Drug Approval Drug Industry--legislation & jurisprudence.

Contents	What is a Combination Product? / Susan Neadle -- Regulatory Strategies / Suzette Roan -- cGMPs / Susan Neadle and Mike Wallenstein -- Integrated Development / Susan Neadle -- Risk Management / Susan Neadle, Richard Wedge, and Edwin Bills -- Human Factors Engineering in the Design, Development and Lifecycle of Combination Products / Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble -- Lifecycle Management: Design Transfer through Post Market / Susan Neadle and Khaudeja Bano -- Best Practices and Considerations for Combination Products Inspection Readiness / Susan Neadle -- US Combination Product Inspections / Kim Trautman -- Supplier Quality Considerations / Fran DeGrazio and Meera Raghuram -- Analytical Testing Considerations / Daniel Bantz and Jennifer Riter -- Biological Products Considerations / Manfred Maeder -- Connected Health / Ryan McGowan -- Evolving Global Regulatory Landscape / Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle.
Abstract	"Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the FDA, "a combination product is one composed of any combination of a drug, a device, and a biological product. Examples include prefilled syringes, pen injectors, auto-injectors, inhalers, transdermal pumps and patches, and kits containing drug administration devices or components. This handbook provides the most up to date information on the development of combination products, from the technology involved to successful delivery. The authors present important and up to the minute pre and post market reviews of combination products as well as regulation"-- Provided by publisher.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2022053545
ISBN	9781032291628 (hardback)
ISBN	9781032291635 (paperback)
ISBN	(ebook)

The combination products handbook a practical guide / edited by Susan W. Neadle.

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