Guidebook for drug regulatory submissions / (Record no. 57853)

MARC details
000 -LEADER
fixed length control field 01442nam\a2200301\a\4500
001 - CONTROL NUMBER
control field 57853
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20260628152406.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 260628s2009 njua b 001 0 eng
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9780470371381
Qualifying information hbk.
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 0470371382
Qualifying information hbk.
040 ## - CATALOGING SOURCE
Original cataloging agency DNLM/DLC
Transcribing agency DLC
Modifying agency YDX
-- NLM
-- BTCTA
-- YDXCP
-- CDX
-- BWX
-- IXA
-- BD-DhIUB
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 344.7304233
Edition number 22
Item number W4231g
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Weinberg, Sandy,
Dates associated with a name 1950-
245 10 - 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, N.J. :
Name of publisher, distributor, etc Wiley,
Date of publication, distribution, etc c2009.
300 ## - PHYSICAL DESCRIPTION
Extent x, 379 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 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.
526 ## - STUDY PROGRAM INFORMATION NOTE
School name Pharmacy
Department Pharmacy
Shelving Location Pharmacy Corner
541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE
Source of acquisition Karim International
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs
General subdivision Law and legislation
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug approval
Geographic subdivision United States.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Approval
Geographic subdivision United States.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs, Investigational
Geographic subdivision United States.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Books
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Source of acquisition Cost, normal purchase price Serial Enumeration / chronology Total Checkouts Full call number Barcode Date last seen Copy number Cost, replacement price Price effective from Koha item type
    Dewey Decimal Classification   Not For Loan Library, Independent University, Bangladesh (IUB) Library, Independent University, Bangladesh (IUB) Pharmacy Corner 21/06/2026 Purchase 9690.00 2009   344.7304233 W4231g 029831 28/06/2026 01 19380.00 21/06/2026 Books