MARC details
| 000 -LEADER |
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| fixed length control field |
04044cam a22004934i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
15634211 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20200915134542.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
090219s2009 nyua b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
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| LC control number |
2009007532 |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER |
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| Record control number |
101496762 |
| Source |
DNLM |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781420088496 (hardcover : alk. paper) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
1420088491 (hardcover : alk. paper) |
| 035 ## - SYSTEM CONTROL NUMBER |
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| System control number |
(OCoLC)ocn311059894 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
DNLM/DLC |
| Transcribing agency |
DLC |
| Modifying agency |
BTCTA |
| -- |
BAKER |
| -- |
YDXCP |
| -- |
NLM |
| -- |
C#P |
| -- |
BWX |
| -- |
DLC |
| Description conventions |
rda |
| 042 ## - AUTHENTICATION CODE |
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| Authentication code |
pcc |
| 043 ## - GEOGRAPHIC AREA CODE |
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| Geographic area code |
n-us--- |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RS189 |
| Item number |
.N476 2009 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.1 |
| Edition number |
22 |
| Item number |
N |
| 245 00 - TITLE STATEMENT |
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| Title |
New drug approval process / |
| Statement of responsibility, etc |
edited by Richard A. Guarino. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
fifth edition. |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York : |
| Name of publisher, distributor, etc |
Informa Healthcare, |
| Date of publication, distribution, etc |
[2010] |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xviii, 529 pages : |
| Other physical details |
illustrations ; |
| Dimensions |
24 cm |
| 336 ## - CONTENT TYPE |
|---|
| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
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| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
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| Source |
rdacarrier |
| Carrier type term |
volume |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Drugs and the pharmaceutical sciences ; |
| Volume number/sequential designation |
v. 190 |
| 500 ## - GENERAL NOTE |
|---|
| General note |
pharmacy bookfair2016 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Front Cover --<br/>Preface --<br/>Contents --<br/>PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT --<br/>1. Drug Development Teams --<br/>2. FDA Approvable Indications and Other Considerations --<br/>3. Data Presentation for Global Submissions: Text and Tabular Exposition-CTD Format --<br/>4. Technology Change-Enabling Clinical Research and Drug Development Processes --<br/>5. Working with a Contract Research Organization (CRO) --<br/>6 Industry and FDA Liaison --<br/>PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL --<br/>7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology --<br/>8. The Investigational New Drug Application (IND), the Investigational Medicinal Product Dossier (IMPD) and the Investigator's Brochure (IB) --<br/>9. New Product Applications for Global Pharmaceutical Product Approvals: U.S. NDA Vs. Global CTD Formats --<br/>10. Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) --<br/>11. The CTD and eCTD for the Registration of Pharmaceuticals for Human Use --<br/>12. The Biologic License Application --<br/>13. Chemistry, Manufacturing, and Control (ICH Quality Guidelines) --<br/>14. New Medical Device Approval Process in the United States --<br/>15. Orphan Drugs --<br/>PART III DEVELOPING CLINICAL RESEARCH TRIALS --<br/>16. Clinical Research Protocols --<br/>17. Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in the U.S. and Foreign Clinical Trials --<br/>18. HIPAA: A New Requirement to the Clinical Study Pr --<br/>19. Adverse Events and Reactions: Etiology, Drug Interactions, Collection, andReporting --<br/>20. Biostatistics in Pharmaceutical Product Development Facts, Recommendations, and Solutions --<br/>PART IV GLOBAL REGULATIONS FOR GOOD CLINICAL PRACTICES (GCP) --<br/>21. CFR/ICH/EU GCP Obligations of Investigators, Sponsors, andMonitors --<br/>22. Quality Assurance. 23. Managing and Monitoring Clinical Trials --<br/>24. European CT Directive: Implementation and Update --<br/>PART V SPECIFIC AREAS OF NEW PRODUCT SUBMISSIONS --<br/>25. Combination Products --<br/>26. The Current State of GXP in China --<br/>Acronyms and Initialisms --<br/>Index. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug approval |
| Geographic subdivision |
United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Testing |
| -- |
Standards. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Testing |
| -- |
Government policy |
| Geographic subdivision |
United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
New products |
| General subdivision |
Government policy |
| Geographic subdivision |
United States. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Evaluation |
| General subdivision |
standards |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
8637 |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical Trials as Topic |
| General subdivision |
standards |
| Geographic subdivision |
United States. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Approval |
| Geographic subdivision |
United States. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Guarino, Richard A., |
| Dates associated with a name |
1935-, |
| Relator term |
editor. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Drugs and the pharmaceutical sciences ; |
| Volume number/sequential designation |
v. 190. |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Abstract |
| Uniform Resource Identifier |
<a href="http://repository.fue.edu.eg/xmlui/handle/123456789/1816">http://repository.fue.edu.eg/xmlui/handle/123456789/1816</a> |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
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| 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 |