The Resource New drug approval process, edited by Richard A. Guarino

New drug approval process, edited by Richard A. Guarino

Label
New drug approval process
Title
New drug approval process
Statement of responsibility
edited by Richard A. Guarino
Contributor
Subject
Language
eng
Summary
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed
Member of
Cataloging source
N$T
Dewey number
615/.1
Illustrations
illustrations
Index
index present
LC call number
RS189
LC item number
.N476 2009eb
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Drugs and the pharmaceutical sciences series
Series volume
v. 190
Label
New drug approval process, edited by Richard A. Guarino
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Front Cover; Preface; Contents; PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT; 1. Drug Development Teams; 2. FDA Approvable Indications and Other Considerations; 3. Data Presentation for Global Submissions: Text and Tabular Exposition -- CTD Format; 4. Technology Change -- Enabling Clinical Research and Drug Development Processes; 5. Working with a Contract Research Organization (CRO); 6 Industry and FDA Liaison; PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL; 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology
Control code
ocn466868975
Dimensions
unknown
Edition
5th ed
Extent
1 online resource (xviii, 529 pages)
File format
unknown
Form of item
online
Isbn
9781420088502
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
Quality assurance targets
not applicable
http://library.link/vocab/recordID
.b24475257
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
  • (OCoLC)466868975
  • pebco1420088505

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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