MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03839cam a22004814a 4500 |
| 001 - CONTROL NUMBER |
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| control field |
15470914 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
EG-NcFUE |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20200216144714.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
080926s2018 nyua 001 0 eng |
| 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 |
9781138381285 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420070422 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Cancelled/invalid ISBN |
9781420070422 (hardcover : alk. paper) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| Cancelled/invalid ISBN |
1420070428 (hardcover : alk. paper) |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)ocn259902129 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)259902129 |
| Canceled/invalid control number |
(OCoLC)166379234 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DNLM/DLC |
| Transcribing agency |
DLC |
| Modifying agency |
BTCTA |
| -- |
BAKER |
| -- |
YDXCP |
| -- |
NLM |
| -- |
C#P |
| -- |
BWX |
| -- |
DLC |
| 043 ## - GEOGRAPHIC AREA CODE |
|---|
| Geographic area code |
n-us--- |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
344.7304233 |
| Edition number |
22 |
| Item number |
P. |
| 245 04 - TITLE STATEMENT |
|---|
| Title |
The pharmaceutical regulatory process / |
| Statement of responsibility, etc |
edited by Ira R. Berry, Robert P. Martin. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Second edition. |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
Boca Raton : |
| Name of publisher, distributor, etc |
CRC Press, |
| Date of publication, distribution, etc |
2018. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
x, 469 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 |
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. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| 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. |
| 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. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Legislation, Drug |
| Geographic subdivision |
United States. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Guideline Adherence |
| General subdivision |
legislation & jurisprudence |
| Geographic subdivision |
United States. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Preparations |
| General subdivision |
standards |
| Geographic subdivision |
United States. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Berry, Ira R., |
| Dates associated with a name |
1942- |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Martin, Robert P. |
| Fuller form of name |
(Robert Paul) |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Drugs and the pharmaceutical sciences ; |
| Volume number/sequential designation |
v. 185. |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
orignew |
| d |
1 |
| e |
ecip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |