Drug Development for Gene Therapy (Record no. 67151)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04194nam a22003974u 4500 |
| 001 - CONTROL NUMBER | |
| control field | 10.1002/9781119852810 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | Wiley |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251030120314.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mam|a |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240216t2024||||xxu fs| |0|| 0|eng|| |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781119852810 |
| Qualifying information | electronic |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1002/9781119852810 |
| Source of number or code | doi |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | eng |
| 245 00 - TITLE STATEMENT | |
| Title | Drug Development for Gene Therapy |
| Remainder of title | Translational Biomarkers, Bioanalysis, and Companion Diagnostics |
| Medium | [electronic resource] |
| Statement of responsibility, etc. | Edited by Yanmei Lu, Boris Gorovits. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1 |
| 260 ## - Date publicare | |
| Name of publisher, distributor, etc. | Wiley |
| Date of publication, distribution, etc. | 2024 |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Name of producer, publisher, distributor, manufacturer | Wiley |
| Date of production, publication, distribution, manufacture, or copyright notice | 2024 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 496pp.; |
| 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 |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Source | rdaft |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| Encoding format | |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids Detection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products Nonclinical and clinical study considerations and methods for biodistribution and shedding Quantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy Detection and quantification of rAAV integration and off-target editing Current regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences. |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 91621 |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 91931 |
| 650 #4 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 91405 |
| 653 00 - INDEX TERM--UNCONTROLLED | |
| Uncontrolled term | gene therapy modalities; Clinical Laboratory Improvement Amendments; CLIA; pcr tests; immunoassays; humoral immune responses; AAV capsid proteins; gene therapy regulation; gene therapy safety; cellular immunity |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lu, Yanmei |
| Relator code | edt |
| 9 (RLIN) | 91932 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gorovits, Boris |
| Relator code | edt |
| 9 (RLIN) | 91933 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9781119852780 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1002/9781119852810">https://doi.org/10.1002/9781119852810</a> |
| Host name | Wiley Online Library |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://onlinelibrary.wiley.com/action/showBook?doi=10.1002%2F9781119852810">https://onlinelibrary.wiley.com/action/showBook?doi=10.1002%2F9781119852810</a> |
| Host name | Wiley Online Library |
| 856 42 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | Cover Image |
| Uniform Resource Identifier | <a href="https://onlinelibrary.wiley.com/cms/asset/17752019-d00d-409c-9cc8-a904fe0ba998/9781119852810.cover.gif">https://onlinelibrary.wiley.com/cms/asset/17752019-d00d-409c-9cc8-a904fe0ba998/9781119852810.cover.gif</a> |
| Host name | Wiley Online Library |
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