MARC details
| 000 -LEADER |
| fixed length control field |
01804cam a2200373 i 4500 |
| 001 - CONTROL NUMBER |
| control field |
55589671 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
| control field |
20210307111803.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
| fixed length control field |
040604s2004 nyua b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
| International Standard Book Number |
0824750411 |
| 040 ## - CATALOGING SOURCE |
| Original cataloging agency |
YEH |
| Transcribing agency |
YEH |
| Modifying agency |
IXA |
| -- |
MXC |
| Description conventions |
rda |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
| Edition number |
22 |
| Classification number |
615.1 |
| Item number |
N. |
| 245 00 - TITLE STATEMENT |
| Title |
New drug approval process : |
| Remainder of title |
accelerating global registrations / |
| Statement of responsibility, etc |
edited by Richard A. Guarino, M.D., oxford pharmaceutical resources, inc., Totowa, New Jersey, U.S.A. |
| 250 ## - EDITION STATEMENT |
| Edition statement |
Fourth edition |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
| Place of publication, distribution, etc |
New York : |
| Name of publisher, distributor, etc |
Marcel Dekker Inc., |
| Date of publication, distribution, etc |
[2004] |
| 264 #4 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
| Date of publication, distribution, etc |
©2004 |
| 300 ## - PHYSICAL DESCRIPTION |
| Extent |
xiv, 635 pages : |
| Other physical details |
illustrations (black and white) ; |
| Dimensions |
24 cm |
| 336 ## - CONTENT TYPE |
| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
| Source |
rdacarrier |
| Carrier type term |
volume |
| 490 1# - SERIES STATEMENT |
| Series statement |
Drugs and the pharmaceutical sciences ; |
| Volume number/sequential designation |
v. 139 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
| Bibliography, etc |
Includes bibliographical references and index |
| 505 0# - FORMATTED CONTENTS NOTE |
| Formatted contents note |
pt. 1. Regulatory practices and procedures of new drug, biologic, and device development --<br/>pt. 2. Clinical research development --<br/>pt. 3. Specific aspects in the process of new product submissions --<br/>pt. 4. Global applications of good clinical practices (GCPs) --<br/>pt. 5. Effective and new methodologies in expediting new product approvals in the U.S. and European Union. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Drug approval |
| Geographic subdivision |
United States |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Testing |
| -- |
Standards |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Testing |
| -- |
Government policy |
| Geographic subdivision |
United States |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
New products |
| General subdivision |
Government policy |
| Geographic subdivision |
United States |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Clinical Trials as Topic |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Drug Evaluation |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
| Topical term or geographic name as entry element |
Drug Approval |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
| Personal name |
Guarino, Richard A., |
| Dates associated with a name |
1935-, |
| Relator term |
editor. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
| Title of a work |
Drugs and the pharmaceutical sciences |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |