The combination products handbook : (Record no. 56106)
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| control field | on1376455148 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | EBZ |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251029164107.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu---unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 230419s2023 flua o 000 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | EBZ |
| Language of cataloging | eng |
| Transcribing agency | EBZ |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781003300298 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1003300294 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000874567 |
| Qualifying information | (electronic bk. : PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000874587 |
| Qualifying information | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000874583 |
| Qualifying information | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000874563 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781032291628 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 1032291621 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1201/9781003300298 |
| Source of number or code | doi |
| 037 ## - SOURCE OF ACQUISITION | |
| Stock number | 9781003300298 |
| Source of stock number/acquisition | Taylor & Francis |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RS192 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 009000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 071000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 072000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | TDCW |
| Source | bicssc |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | MAIN |
| 245 04 - TITLE STATEMENT | |
| Title | The combination products handbook : |
| Remainder of title | a practical guide for combination products and other combined use systems / |
| Statement of responsibility, etc. | edited by Susan Neadle. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Boca Raton : |
| Name of producer, publisher, distributor, manufacturer | CRC Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2023. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (480 pages) : |
| Other physical details | illustrations (black and white, and colour). |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 341 0# - | |
| -- | textual |
| -- | sapdv |
| -- | EBSCOhost |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), a combinationproduct is one composed of any combination of a drug and a device; a biological product anda device; a drug and a biological product; or a drug, device and a biological product. Examplesinclude prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal patches, drug-elutingstents, and kits containing drug administration devices co-packaged with drugs and/or biologicalproducts. This handbook provides the most up-to-date information on the development of combinationproducts, from the technology involved to successful delivery to market. The authors presentimportant and up-to-the-minute pre- and post-market reviews of combination product regulations,guidance, considerations and best practices. This handbook: Brings clarity of understanding for combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert withover 35 years of industry experience and has an outstanding team of contributors. Endorsed byAAMI - Association for the Advancement of Medical Instrumentation. |
| 532 #0 - | |
| -- | EBSCOhost |
| -- | "EBSCO evaluates our products based on the Web Content Accessibility Guidelines (WCAG) and the related Section 508 and EN 301 549 regulations in the US and EU. Most EBSCO products are substantially conformant with WCAG 2.2 level AA." Source: https://connect.ebsco.com/s/article/EBSCO-VPATs?language=en_US. Last accessed April 22, 2025. |
| 545 0# - BIOGRAPHICAL OR HISTORICAL DATA | |
| Biographical or historical data | Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge and genuine passion for sharing that knowledge with others. Susan's leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA's 2021 Awards for Regulatory Affairs Excellence. She serves as Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and complex program management experience to provide international quality & compliance, regulatory, design excellence and executive advisory consulting services to the pharmaceutical, biotech and medical device industries. Among her significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, lead author on the AAMI Combination Products Steering Committee, active member in Combination Products Coalition, and serves as faculty at AAMI and at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences for Combination Products Curricula. Susan retired from Johnson & Johnson, where her distinguished 26+ year-career included integral leadership roles in R&D, Quality Engineering, Design-to-Value, and Quality Systems Management, spanning pharmaceuticals/biotech, medical devices, and consumer health sectors, as well as strategic leadership at J&J corporate level. She served as Chair of J&J's Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's cross-sector Combination Products Community of Practice.Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations for Janssen, J&J's Pharmaceutical sector, and was awarded the Johnson Medal for excellence in Research and Development. Susan also served as Executive Director and Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She was as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction. |
| 588 0# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Print version record. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 64721 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
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| Source of heading or term | bisacsh |
| 9 (RLIN) | 63891 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| Source of heading or term | bisacsh |
| 9 (RLIN) | 64250 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| Source of heading or term | bisacsh |
| 9 (RLIN) | 64669 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Neadle, Susan W., |
| Relator term | editor. |
| 9 (RLIN) | 65004 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Title | Combination products handbook. |
| Place, publisher, and date of publication | Boca Raton : CRC Press, 2023 |
| International Standard Book Number | 9781032291628 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | EBSCOhost |
| Uniform Resource Identifier | <a href="https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3591390">https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=3591390</a> |
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| -- | EBSCOhost |
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