Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes. (Record no. 22174927)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01315 a2200373 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250516114613.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 201308s 0 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER | |
| International Standard Serial Number | 1550-7416 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1208/s12248-012-9414-x |
| Source of number or code | doi |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | NLM |
| Language of cataloging | eng |
| Transcribing agency | NLM |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Pourvasei, Ramak |
| 264 #0 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | 20130802 |
| 245 00 - TITLE STATEMENT | |
| Title | Specific method validation and sample analysis approaches for biocomparability studies of denosumab addressing method and manufacture site changes. |
| Medium | [electronic resource] |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Name of publisher, distributor, etc. | The AAPS journal |
| Date of publication, distribution, etc. | Jan 2013 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 70-7 p. |
| Other physical details | digital |
| 500 ## - GENERAL NOTE | |
| General note | Publication Type: Journal Article; Validation Study |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Antibodies, Monoclonal, Humanized |
| General subdivision | analysis |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Denosumab |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Enzyme-Linked Immunosorbent Assay |
| General subdivision | methods |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Humans |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | RANK Ligand |
| General subdivision | antagonists & inhibitors |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Reagent Kits, Diagnostic |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lee, Ed |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Eschenberg, Michael |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Patel, Vimal |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Macaraeg, Chris |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pandya, Kinnari |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Shih, Judy |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ma, Mark |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lee, Jean W |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | DeSilva, Binodh |
| 773 0# - HOST ITEM ENTRY | |
| Title | The AAPS journal |
| Related parts | vol. 15 |
| -- | no. 1 |
| -- | p. 70-7 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1208/s12248-012-9414-x">https://doi.org/10.1208/s12248-012-9414-x</a> |
| Public note | Available from publisher's website |
No items available.