| 000 -LEADER |
|---|
| fixed length control field |
01590cam a22002654a 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20191015141204.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
080110s2008 njua b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780470050941 (hbk.) |
| 041 ## - Language |
|---|
| Language code of text/sound track or separate title |
eng |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
363.1946 |
| Edition number |
22 |
| Item number |
D487 |
| 245 00 - IMMEDIATE SOURCE OF ACQUISITION NOTE |
|---|
| Title |
Development and approval of combination products : |
| 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 |
2008. |
| 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. |
| 610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
United States. |
| Subordinate unit |
Food and Drug Administration. |
| 9 (RLIN) |
11360 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug approval |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11362 |
|
|---|
| Topical term or geographic name as entry element |
Biological products |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11363 |
|
|---|
| Topical term or geographic name as entry element |
Medical instruments and apparatus |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11364 |
|
|---|
| Topical term or geographic name as entry element |
Drug Approval |
| General subdivision |
legislation & jurisprudence |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11365 |
|
|---|
| Topical term or geographic name as entry element |
Drug Combinations |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11366 |
|
|---|
| Topical term or geographic name as entry element |
Device Approval |
| General subdivision |
legislation & jurisprudence |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
11367 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Siegel, Evan B. |
| 9 (RLIN) |
11368 |
| Relator term |
editor |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Item type |
Book |
