MARC details
000 -LEADER |
fixed length control field |
nam a22 7a 4500 |
001 - CONTROL NUMBER |
control field |
39349 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
BD-DhAAL |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
220814r20222008nyua b 001 0 eng d |
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
LC control number |
2008042661 |
016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
Record control number |
101485457 |
Source |
DNLM |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9780367202842 |
|
International Standard Book Number |
9781420070422 (hardcover : alk. paper) |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
BD-DhAAL |
Transcribing agency |
BD-DhAAL |
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
Classification number |
344.7304233 |
Edition number |
23 |
245 04 - TITLE STATEMENT |
Title |
The pharmaceutical regulatory process / |
Statement of responsibility, etc |
edited by Ira R. Berry, Robert P. Martin. |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
Place of publication, distribution, etc |
New York : |
Name of publisher, distributor, etc |
Informa Healthcare, |
Date of publication, distribution, etc |
c2008 [reprinted 2022]. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
x, 469 pages : |
Other physical details |
illustrations ; |
Dimensions |
24 cm. |
490 1# - SERIES STATEMENT |
Series statement |
Drugs and the pharmaceutical sciences ; |
Volume number/sequential designation |
185 |
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 / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug approval- process - before and after 1962 / Michael P. Peskoe -- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England. |
|
Formatted contents note |
Active pharmaceutical ingredients / Max S. Lazar -- Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham. |
526 ## - STUDY PROGRAM INFORMATION NOTE |
Program name |
PHR |
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) |
50825 |
|
Topical term or geographic name as entry element |
Drugs |
General subdivision |
Law and legislation |
Geographic subdivision |
United States. |
9 (RLIN) |
50826 |
|
Topical term or geographic name as entry element |
Legislation, Drug |
Geographic subdivision |
United States. |
9 (RLIN) |
50827 |
|
Topical term or geographic name as entry element |
Guideline Adherence |
General subdivision |
legislation & jurisprudence |
Geographic subdivision |
United States. |
9 (RLIN) |
50828 |
|
Topical term or geographic name as entry element |
Pharmaceutical Preparations |
General subdivision |
standards |
Geographic subdivision |
United States. |
9 (RLIN) |
50829 |
|
Topical term or geographic name as entry element |
Pharmacy. |
9 (RLIN) |
50830 |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Berry, Ira R., |
Dates associated with a name |
1942- |
9 (RLIN) |
50831 |
|
Personal name |
Martin, Robert P. |
Fuller form of name |
(Robert Paul) |
9 (RLIN) |
50832 |
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
Uniform title |
Drugs and the pharmaceutical sciences ; |
Volume number/sequential designation |
v. 185. |
9 (RLIN) |
50833 |
852 ## - LOCATION/CALL NUMBER |
Location |
Ayesha Abed Library |
Shelving location |
General Stacks |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Source of classification or shelving scheme |
Dewey Decimal Classification |
Item type |
Book |