MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03051cam a2200349 a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
13833863 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20210302132710.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
050107s2005 nyua b 001 0 eng d |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2005041971 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824754646 (alk. paper) |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
EG-NcFUE |
| Transcribing agency |
EG-NcFUE |
| Description conventions |
rda |
| 043 ## - GEOGRAPHIC AREA CODE |
|---|
| Geographic area code |
n-us--- |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
KF2036.D7 |
| Item number |
P47 2005 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Edition number |
22 |
| Classification number |
344.7304233 |
| Item number |
P |
| 245 04 - TITLE STATEMENT |
|---|
| Title |
The pharmaceutical regulatory process / |
| Statement of responsibility, etc |
edited by Ira R. Berry. |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York : |
| Name of publisher, distributor, etc |
Marcel Dekker, |
| Date of publication, distribution, etc |
2005. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xiii, 711 pages : |
| Other physical details |
illustrations ; |
| Dimensions |
25 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 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act. New Drug Approval Process: Before and After 1962. FDA Regulation of Biological Products. Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs. Generic Drug Approval Process: Post 1984: Waxman-Hatch Reform. Food and Drug Administration Modernization Act. FDA's Antibiotic Regulatory Scheme: Then and Now. Pioneer and Generic Drugs: Balance Between Product Life Cycle Extension and Anti-Competitive Behavior. The Influence of the Prescription Drug User Fee Act on the Approval Process. Clinical Research Requirements for New Drug Applications. Active Pharmaceutical Ingredients. Obtaining Approval of a New Drug . Obtaining Approval of a Generic Drug. Current Good Manufacturing Practice and the Drug Approval Process. CMC Post-Approval Regulatory Affairs: Constantly Managing Change. The Influence of the USP on the Drug Approval Process. Ways and Means to U.S. Registration of Foreign Drugs. Common Technical Document-Quality (M4-Q): One Regulatory Participant's Perspective. 21 CFR Part 11: Compliance and Beyond. Marketing and Advertising Promotion: The Impact of Government Regulations. Approval and Marketing of Nonprescription or OTC Human Drugs.<br/> |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
"Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States - standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality issues influencing the pharmaceutical industry."--book jacket. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmacy |
| General subdivision |
Law and legislation |
| Geographic subdivision |
United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Law and legislation |
| Geographic subdivision |
United States. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Berry, Ira R., |
| Dates associated with a name |
1942- |
| Relator term |
author |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Publisher description |
| Uniform Resource Identifier |
<a href="http://www.loc.gov/catdir/enhancements/fy0647/2005041971-d.html">http://www.loc.gov/catdir/enhancements/fy0647/2005041971-d.html</a> |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
orignew |
| d |
1 |
| e |
ocip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |