New drug approval process : (Record no. 5195)

000 -LEADER
fixed length control field 03028nam a2200373Ia 4500
001 - CONTROL NUMBER
EWU control number 5195
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190305152805.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 061206s2004 nyu 001 0 en d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0824750411 Hard bound
International Standard Book Number 9780824750411
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCoLC)55589671
040 ## - CATALOGING SOURCE
Original cataloging agency BD-DhEWU
Modifying agency BD-DhEWU
Language of cataloging eng
Transcribing agency BD-DhEWU
041 ## - LANGUAGE CODE
Language code of text/sound track or separate title eng
082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.10973
Author mark and Year NEW 2004
DDC edition 22
245 10 - TITLE STATEMENT
Title New drug approval process :
Remainder of title accelerating global registrations /
Statement of responsibility, etc edited by- Guarino, Richard A.
250 ## - EDITION STATEMENT
Edition statement 4th ed.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New York :
Name of publisher, distributor, etc Marcel Dekker, Inc.,
Date of publication, distribution, etc c2004.
300 ## - PHYSICAL DESCRIPTION
Extent xiv, 635 p. :
Other physical details figures, tables, ill. ;
Dimensions 22 cm.
440 ## -
Title Drugs and the pharmaceutical sciences.
-- 24177
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes Bibliographical References and Index.
505 ## - FORMATTED CONTENTS NOTE
Contents note Part I : Regulatory practices and procedures of new drug, biologic and device development --<br/>Drug development teams --<br/>Nonclinical drug development --<br/>The investigational new drug application and the investigator's brochure --<br/>General considerations of the new drug application --<br/>The new drug application, content and format --<br/>Abbreviated and supplemental new drug applications --<br/>The biologics license application --<br/>Device legislation and application --<br/>Orphan drugs --<br/>Part II : Clinical research development --<br/>Adverse experiences, adverse reactions, interactions of drugs --<br/>Biostatistics in pharmaceutical product development --<br/>Industry and FDA liasion --<br/>Part III : Specific aspects in the process of new product submissions --<br/>Chemistry, manufacturing, and control requirements of the NDA and ANDA --<br/>Data presentation for FDA submissions --<br/>Preparing for FDA inspections --<br/>Technology change --<br/>The common technical document for the registration of pharmaceutical for human use --<br/>Part IV : Global applications of good clinical practices --<br/>Obligations of the investigator, sponsor, monitor --<br/>Instituitional review board --<br/>Quality assurance --<br/>Managing clinical trials --<br/>The European union directive on good clinical parctice in clinical trials --<br/>HIPAA --<br/>Part V : Effective and new methodologies in expediting new product approvals in the US and European union --<br/>Working with a CRO --<br/>The evolving SMO in the US --<br/>Accelerating new product approvals.
Title Table of contents
520 ## - SUMMARY, ETC.
Summary, etc Clarifying how to develop and market new drugs efficiently and economically for global markets, this text covers the emphasis on over-the-counter drugs in the long-range plans of many companies and discusses licence applications review boards.
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Drug Approval
9 (RLIN) 8339
Topical term or geographic name Drug Evaluation
9 (RLIN) 8340
Topical term or geographic name Clinical Trials as Topic
9 (RLIN) 8341
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Guarino, Richard A.
9 (RLIN) 8343
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified WorldCat details
Uniform Resource Identifier http://www.worldcat.org/title/new-drug-approval-process-accelerating-global-registrations/oclc/55589671&referer=brief_results
Materials Specified Ebook Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/5195
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Text
Source of classification or shelving scheme
953 ## - Fulltext in GSDL
Is Fulltext Available in GSDL? Not Avaialable
Holdings
Lost status Source of classification or shelving scheme Not for loan Collection code Permanent Location Current Location Shelving location Date of accession Source of acquisition Cost, normal purchase price Full call number Barcode Copy number Koha item type Date last seen Price effective from
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2006-12-06 Parash Publishers 13870.00 615.10973 NEW 2004 19384 C-1 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2006-12-06 Bangaldesh Photostat 864.00 615.10973 NEW 2004 19385 C-2 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2006-12-06 Bangaldesh Photostat 864.00 615.10973 NEW 2004 19386 C-3 Text    
      Non-fiction EWU Library EWU Library E-book 2018-01-06     615.10973 NEW 2004     E-Book 2018-01-06 2018-01-06

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