MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03503cam a2200349 a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
5241 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
BD-DhEWU |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20190310095357.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
050107s2005 nyua g b 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824754646 (alk. paper) |
|
|---|
| International Standard Book Number |
9780824754648 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)57434176 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Transcribing agency |
DLC |
| Modifying agency |
DLC |
| -- |
BD-DhEWU |
| Language of cataloging |
eng |
| 041 ## - LANGUAGE CODE |
|---|
| Language code of text/sound track or separate title |
eng |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
KF2036.D7 |
| Item number |
P47 2005 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.173 |
| Item number |
PHA 2005 |
| 245 04 - TITLE STATEMENT |
|---|
| Title |
The pharmaceutical regulatory process / |
| Statement of responsibility, etc |
edited by Ira R. Berry. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York ; |
| -- |
Dhaka : |
| Name of publisher, distributor, etc |
Marcel Dekker ; |
| -- |
Bangladesh Photostat, |
| Date of publication, distribution, etc |
2005. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xiii, 711 p. : |
| Other physical details |
ill. ; |
| Dimensions |
25 cm. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 ## - FORMATTED CONTENTS NOTE |
|---|
| Title |
TOC |
| Formatted contents note |
Pharmaceutical regulation before and after the food, drug, and cosmetic act / John P. Swann --<br/>The new drug-approval process-before and after 1962 / Michael P. Peskoe --<br/>FDA regulation of biological products / James N. Czaban and Natasha Leskovsek --<br/>Generic drug approval process: pre-1984 history concerning generic drugs / David L. Rosen --<br/>Generic drug approval process, post-1984: Hatch-Waxman reform / Marc S. Gross ...[et al.] --<br/>Food and drug administration modernization act / Arthur Y. Tsien and Patricia E. Pahl --<br/>FDA Antibiotic regulatory scheme: then and now / Irving L. Wiesen --<br/>Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior / Robert G. Pinco and Barbara A. Binzak --<br/>The influence of the prescription drug user fee act on the approval process / Marc J. Scheineson --<br/>Clinical research requirements for new drug applications / Gary Yingling and Ann Begly --<br/>Active pharmaceutical ingredients / Max S. Lazar --<br/>Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah --<br/>Obtaining approval of a generic drug / Loren Gelber --<br/>Current good manufacturing practice and the drug approval process / Nicholas Buhay --<br/>CMC post-approval regulatory affairs: constantly managing change / Leo J. Lucisano and Kevin A. Miller --<br/>The influence of the USP on the drug approval process / Edward M. Cohen --<br/>Ways and means to U.S. registration of foreign drugs / Alberto Grignolo ...[et al.] --<br/>Common techinical document-quality (M4-Q): one regulatory participant's perspective / Ubrani V. Venkataram --<br/>21 CFR part 11 compliance and beyond / Richard L. Burcham --<br/>Marketing and advertising/promotion: the impact of government regulations / Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg --<br/>Approval and marketing of nonprescription or OTC human drugs / William J. Mead. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
Summary:<br/>A tool to navigate and understand the pharmaceutical regulatory framework. Covering the procedures utilized by pharmaceutical companies for regulatory compliance, this book describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States. |
| 526 ## - STUDY PROGRAM INFORMATION NOTE |
|---|
| Program name |
Pharmacy |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
Tahur Ahmed |
| 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. |
| 9 (RLIN) |
8533 |
|
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Law and legislation |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
8534 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Berry, Ira R. |
| 9 (RLIN) |
8535 |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
WorldCat details |
| Uniform Resource Identifier |
http://www.worldcat.org/title/pharmaceutical-regulatory-process/oclc/57434176&referer=brief_results |
|
|---|
| Materials specified |
Ebook Fulltext |
| Uniform Resource Identifier |
http://lib.ewubd.edu/ebook/5241 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Text |