Development and regulation of cellular and gene therapy products (Record no. 75640)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02172ngm a2200445 a 4500 |
| 001 - CONTROL NUMBER | |
| control field | HST5636 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | UkLoHST |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m c |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr|cna|||a|||| |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | vz|czazum |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211204s2021 enk|||||||||||s|||v|eng d |
| 028 50 - PUBLISHER NUMBER | |
| Publisher number | 5636 |
| Source | Henry Stewart Talks |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (UkLoHST)4793 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | UkLoHST |
| Language of cataloging | eng |
| Transcribing agency | UkLoHST |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Lapteva, Larissa, |
| Affiliation | (Center for Biologics Evaluation and Research, FDA, USA) |
| Relator code | spk |
| 245 10 - TITLE STATEMENT | |
| Title | Development and regulation of cellular and gene therapy products |
| Medium | [electronic resource] : |
| Remainder of title | FDA perspective / |
| Statement of responsibility, etc. | Larissa Lapteva. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc. | London : |
| Name of publisher, distributor, etc. | Henry Stewart Talks, |
| Date of publication, distribution, etc. | 2021. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (1 streaming video file (51 min.) : |
| Other physical details | color, sound). |
| 490 1# - SERIES STATEMENT | |
| Series statement | The biomedical & life sciences collection, |
| International Standard Serial Number | 2056-452X |
| 500 ## - GENERAL NOTE | |
| General note | Animated audio-visual presentation with synchronized narration. |
| 500 ## - GENERAL NOTE | |
| General note | Title from title frames. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Contents: Cellular and gene therapy products -- U.S. laws and regulations -- FDA review -- Product development considerations -- Regulatory considerations -- Product manufacturing stages and quality testing -- Safety, efficacy and ethical considerations for clinical program design -- FDA Guidance documents. |
| 506 ## - RESTRICTIONS ON ACCESS NOTE | |
| Terms governing access | Access restricted to subscribers. |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | Mode of access: World Wide Web. |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States |
| Subordinate unit | Food and Drug Administration. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cellular therapy |
| General subdivision | Law and legislation. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cellular therapy |
| General subdivision | Moral and ethical aspects. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Gene therapy |
| General subdivision | Law and legislation. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Gene therapy |
| General subdivision | Moral and ethical aspects. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Human genetics |
| General subdivision | Government policy |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Stem cells |
| General subdivision | Therapeutic use. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cell- and Tissue-Based Therapy |
| General subdivision | ethics. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Cell- and Tissue-Based Therapy |
| General subdivision | standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Genetic Therapy |
| General subdivision | ethics. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Genetic Therapy |
| General subdivision | legislation & jurisprudence. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Genetic Therapy |
| General subdivision | standards. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | United States Food and Drug Administration. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Henry Stewart talks. |
| Name of part/section of a work | Biomedical & life sciences collection. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://hstalks.com/bs/4793/">https://hstalks.com/bs/4793/</a> |
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