MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02019nam a2200301Ia 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
133685 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
0000000000 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20211104015746.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
081022s2009 njua b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780470371381 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(AEA)285949ABCBB347329B3B4D7C932E3ECA |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)ocn246886694 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
15499340 |
| 050 ## - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
KF 3885 |
| Item number |
.W430 2009 |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Weinberg, Sandy, |
| Dates associated with a name |
-1950 |
| 9 (RLIN) |
103759 |
| 245 #0 - TITLE STATEMENT |
|---|
| Title |
Guidebook for drug regulatory submissions / |
| Statement of responsibility, etc. |
Sandy Weinberg. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc. |
Hoboken, NJ : |
| Name of publisher, distributor, etc. |
Wiley, |
| Date of publication, distribution, etc. |
c2009. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
x, 379 p. : |
| Other physical details |
ill. |
| Dimensions |
24 cm. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 ## - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
Offers written guide for effective submisssion of documents for required regulatory views during drug development. Provides information on ht emost common types of submissions, including: Meeting Requestss, Orphan Drug Applications, Investigatory New Drug Applications, 505(b) NDAs, Abbreviated New Drug Applications and Annual Report. Explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submisssions processs over the near future. A chapter compares the FDA processs to the four other major regulatory environments of Canada, European Union, Japan and Australia. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug approval |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
103760 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Approval |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
103761 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
103762 |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs, Investigational |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
103763 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Reference |
