MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02061cam a2200373 i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
4034122 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20210307103309.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
980826s1999 nyua b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
98027750 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824702182 (alk. paper) |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Transcribing agency |
DLC |
| Modifying agency |
DLC |
| Description conventions |
rda |
| 043 ## - GEOGRAPHIC AREA CODE |
|---|
| Geographic area code |
n-us--- |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RM301.27 |
| Item number |
.P74 1999 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.19 |
| Edition number |
22 |
| Item number |
P. |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Preparing for FDA pre-approval inspections / |
| Statement of responsibility, etc |
edited by Martin D. Hynes, III. |
| 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 |
[1999] |
| 264 #4 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Date of publication, distribution, etc |
©1999 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
ix, 284 pages : |
| Other physical details |
illustrations ; |
| 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. 93 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Introduction to the Food and Drug Administration Pre-New Drug Applications Approval Inspections o Developing a Strategic Approach to Preparing for a Successful Pre-NDA Approval Inspection o Food and Drug Administration International Pre-Approval Inspections o Stability Data and Pre-Approval Inspections o Consequences of Failing a Pre-Approval Inspection o Successful Management of a Pre-Approval Inspection o The Validation of Pharmaceutical Processes o Documentation Standards for Pre-Approval Inspections o Technology Transfer and Scale-up o Training of Personnel in the Pharmaceutical Industry o Compliance with Current Good Manufacturing Practices and Application Commitments<br/> |
| 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 |
Drugs |
| General subdivision |
Research |
| -- |
Standards |
| Geographic subdivision |
United States. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Hynes, Martin D. |
| Relator term |
editor. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Title of a work |
Drugs and the pharmaceutical sciences |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Publisher description |
| Uniform Resource Identifier |
<a href="http://www.loc.gov/catdir/enhancements/fy0647/98027750-d.html">http://www.loc.gov/catdir/enhancements/fy0647/98027750-d.html</a> |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
orignew |
| d |
1 |
| e |
ocip |
| f |
19 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |