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 |
