Development and approval of combination products (Record no. 101122)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02030nam a22003854a 4500 |
| 001 - CONTROL NUMBER | |
| control field | ebr10296672 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | CaPaEBR |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS--GENERAL INFORMATION | |
| fixed length control field | m u |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cn||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 080110s2008 njua sb 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER | |
| Canceled/invalid LC control number | 2008001360 |
| 016 7# - NATIONAL BIBLIOGRAPHIC AGENCY CONTROL NUMBER | |
| Canceled or invalid record control number | 101463351 |
| Source | DNLM |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Cancelled/invalid ISBN | 9780470050941 (hbk.) |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | CaPaEBR |
| Transcribing agency | CaPaEBR |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)647764606 |
| 043 ## - GEOGRAPHIC AREA CODE | |
| Geographic area code | n-us--- |
| 050 14 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RA401.5 |
| Item number | .D48 2008eb |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 363.19/46 |
| Edition number | 22 |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (OCLC) | |
| -- | 101122 |
| -- | 80999 |
| 245 00 - TITLE STATEMENT | |
| Title | Development and approval of combination products |
| Medium | [electronic resource] : |
| Remainder of title | a regulatory perspective / |
| Statement of responsibility, etc | edited by Evan B. Siegel. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | Hoboken, N.J. : |
| Name of publisher, distributor, etc | Wiley, |
| Date of publication, distribution, etc | c2008. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | xii, 215 p. : |
| Other physical details | ill. ; |
| Dimensions | 25 cm. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier. |
| 533 ## - REPRODUCTION NOTE | |
| Type of reproduction | Electronic reproduction. |
| Place of reproduction | Palo Alto, Calif. : |
| Agency responsible for reproduction | ebrary, |
| Date of reproduction | 2009. |
| Note about reproduction | Available via World Wide Web. |
| -- | Access may be limited to ebrary affiliated libraries. |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration. |
| 610 12 - SUBJECT ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | United States. |
| Subordinate unit | Food and Drug Administration. |
| 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 | Biological products |
| Geographic subdivision | United States. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Medical instruments and apparatus |
| Geographic subdivision | United States. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | local |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Siegel, Evan B. |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | ebrary, Inc. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://site.ebrary.com/lib/strathmore/Doc?id=10296672">http://site.ebrary.com/lib/strathmore/Doc?id=10296672</a> |
| Public note | An electronic book accessible through the World Wide Web; click to view |
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