Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. (Record no. 17707989)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01751 a2200469 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250515104212.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 200805s 0 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER | |
| International Standard Serial Number | 0091-2700 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1177/0091270007311111 |
| 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 | Wang, Yaning |
| 264 #0 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | 20080519 |
| 245 00 - TITLE STATEMENT | |
| Title | Leveraging prior quantitative knowledge to guide drug development decisions and regulatory science recommendations: impact of FDA pharmacometrics during 2004-2006. |
| Medium | [electronic resource] |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Name of publisher, distributor, etc. | Journal of clinical pharmacology |
| Date of publication, distribution, etc. | Feb 2008 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 146-56 p. |
| Other physical details | digital |
| 500 ## - GENERAL NOTE | |
| General note | Publication Type: Journal Article |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Clinical Trials as Topic |
| General subdivision | methods |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Decision Making |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drug Approval |
| General subdivision | legislation & jurisprudence |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drug Industry |
| General subdivision | legislation & jurisprudence |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Government Regulation |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Guidelines as Topic |
| 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 | Investigational New Drug Application |
| General subdivision | legislation & jurisprudence |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Legislation, Drug |
| General subdivision | standards |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Organizational Objectives |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Time Factors |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | United States |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | United States Food and Drug Administration |
| General subdivision | legislation & jurisprudence |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Bhattaram, A Venkatesh |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Jadhav, Pravin R |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lesko, Lawrence J |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Madabushi, Rajanikanth |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Powell, J Robert |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Qiu, Wei |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Sun, He |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Yim, Dong S |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Zheng, Jenny J |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gobburu, Jogarao V S |
| 773 0# - HOST ITEM ENTRY | |
| Title | Journal of clinical pharmacology |
| Related parts | vol. 48 |
| -- | no. 2 |
| -- | p. 146-56 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1177/0091270007311111">https://doi.org/10.1177/0091270007311111</a> |
| Public note | Available from publisher's website |
No items available.