Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. (Record no. 22671530)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01718 a2200469 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250516144347.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 201309s 0 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER | |
| International Standard Serial Number | 1532-6535 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1038/clpt.2013.70 |
| 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 | Khin, N A |
| 264 #0 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | 20130930 |
| 245 00 - TITLE STATEMENT | |
| Title | Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. |
| Medium | [electronic resource] |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Name of publisher, distributor, etc. | Clinical pharmacology and therapeutics |
| Date of publication, distribution, etc. | Aug 2013 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 230-42 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 | Antipsychotic Agents |
| General subdivision | therapeutic use |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Cardiovascular Agents |
| General subdivision | therapeutic use |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Clinical Trials as Topic |
| General subdivision | legislation & jurisprudence |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drug Approval |
| General subdivision | organization & administration |
| 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 | Internationality |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Orphan Drug Production |
| General subdivision | statistics & numerical data |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmacology, Clinical |
| General subdivision | organization & administration |
| 650 04 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Research Design |
| 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 | Yang, P |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Hung, H M J |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Maung-U, K |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Chen, Y-F |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Meeker-O'Connell, A |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Okwesili, P |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Yasuda, S U |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ball, L K |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Huang, S-M |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | O'Neill, R T |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Temple, R |
| 773 0# - HOST ITEM ENTRY | |
| Title | Clinical pharmacology and therapeutics |
| Related parts | vol. 94 |
| -- | no. 2 |
| -- | p. 230-42 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1038/clpt.2013.70">https://doi.org/10.1038/clpt.2013.70</a> |
| Public note | Available from publisher's website |
No items available.