MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02037nam a2200373 a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
vtls000046904 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
KUKTEM |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20251117144412.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
100705t2008 flua f b 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781420064469 (hardcover : alk. paper) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1420064460 (hardcover : alk. paper) |
| 039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE] |
|---|
| Level of rules in bibliographic description |
201107131934 |
| Level of effort used to assign nonsubject heading access points |
VLOAD |
| Level of effort used to assign subject headings |
201106031148 |
| Level of effort used to assign classification |
Fida |
| Level of effort used to assign subject headings |
201011021700 |
| Level of effort used to assign classification |
fauzi |
| -- |
201007051417 |
| -- |
shikin |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
UMP |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
|---|
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
RM301.27 .G67 2008 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Gopalaswamy, Smita |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Combination products : |
| Remainder of title |
regulatory challenges and successful product developement / |
| Statement of responsibility, etc. |
Smita Gopalaswamy, Venky Gopalaswamy |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Place of publication, distribution, etc. |
Boca Raton : |
| Name of publisher, distributor, etc. |
CRC Press, |
| Date of publication, distribution, etc. |
c2008 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xvi, 241 p. : |
| Other physical details |
ill. ; |
| Dimensions |
25 cm. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographical references and index |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Overview of combination products -- Ensuring successful combination product development -- Overview of FDA and other regulatory agency expectations -- Resource requirements -- Manufacturing of combination products -- Challenges and pitfalls to avoid with combination products -- Postlaunch compliance requirements -- Agency audits and challenges |
| 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 entry element |
Drugs |
| General subdivision |
Standards |
| Geographic subdivision |
United States |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Medical instruments and apparatus |
| General subdivision |
Standards |
| Geographic subdivision |
United States |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biological products |
| General subdivision |
Standards |
| Geographic subdivision |
United States |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Equipment Design |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Pharmaceutical Preparations |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Biological Products |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Device Approval |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Equipment and Supplies |
| General subdivision |
standards |
| Geographic subdivision |
United States |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Gopalaswamy, Venky |
| 856 41 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Table of contents only |
| Uniform Resource Identifier |
<a href="http://www.loc.gov/catdir/toc/ecip082/2007043090.html">http://www.loc.gov/catdir/toc/ecip082/2007043090.html</a> |