Return to home page
Searching: Muskingum library catalog
Some OPAL libraries remain closed or are operating at reduced service levels. Materials from those libraries may not be requestable; requested items may take longer to arrive. Note that pickup procedures may differ between libraries. Please contact your library for new procedures, specific requests, or other assistance.
  Previous Record Previous Item Next Item Next Record
  Reviews, Summaries, etc...
EBOOK
Title New drug approval process : the global challenge / edited by Richard A. Guarino.
Imprint New York : Marcel Dekker, 2000.
Edition 3rd ed.

LOCATION CALL # STATUS MESSAGE
 OHIOLINK NETLIBRARY EBOOKS    ONLINE  
View online
LOCATION CALL # STATUS MESSAGE
 OHIOLINK NETLIBRARY EBOOKS    ONLINE  
View online
Series Drugs and the pharmaceutical sciences ; v. 100
Drugs and the pharmaceutical sciences ; v. 100.
Subject Drugs -- Testing -- Standards.
Drugs -- Testing -- Government policy -- United States.
New products -- Government policy -- United States.
Drug Evaluation -- standards -- United States.
Clinical Trials -- standards -- United States.
Alt Name Guarino, Richard A., 1935-
Description 1 online resource (xxxiii, 471 pages) : illustrations.
Edition 3rd ed.
Bibliography Note Includes bibliographical references and index.
Contents Regulatory aspects of new drug development -- Clinical research development -- Good clinical practices -- The orphan drug and the Rx to OTC switch -- Effective methodology is expediting NDA approval.
Note Print version record.
ISBN 0585231362 (electronic bk.)
9780585231365 (electronic bk.)
0824703081 (alk. paper)
OCLC # 44961525
Additional Format Print version: New drug approval process. 3rd ed. New York : Marcel Dekker, 2000 0824703081 (DLC) 99048629 (OCoLC)42429707
Table of Contents
 Preface 
 Introduction 
 Contributors 
 Acronyms and Initialisms 
Pt. IRegulatory Aspects of New Drug Development 
 1Drug Development Teams / Duane B. Lakings1
 2Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology / Duane B. Lakings17
 3The Investigational New Drug Application and the Investigator's Brochure / William M. Troetel55
 4General Considerations of the NDA / Martha R. Charney93
 5Specific Requirements, Content, and Format of an NDA / Richard A. Guarino, Patricia Blaine103
 6The Biologic License Application (BLA) / Albert A. Ghignone, Douglas Testa157
 7Chemistry, Manufacturing and Control Requirements of the NDA, and ANDA / Ivy Bautista189
Pt. IIClinical Research Development 
 8Clinical Research Protocols / Richard A. Guarino219
 9Adverse Reactions and Interactions of Drugs / Richard A. Guarino247
 10Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Subjects Throughout the Clinical Research Process / Rochelle L. Goodson271
 11Statistical and Data Management: Collaboration in Clinical Research / Laurent M. Kassalow289
 12The Management of Clinical Studies / Ileana Maria Alexander311
Pt. IIIGood Clinical Practices 
 13Obligations of the Investigator, Sponsor, and Monitor / Richard A. Guarino325
 14Preparing for FDA Inspections: Manufacturing Sites / Timothy Urschel335
 15Quality Assurance / Earl W. Hulihan349
Pt. IVThe Orphan Drug and the Rx to OTC Swith 
 16Orphan Drugs / John T. Zenno361
 17Clinical Development, Regulations, and Trends for OTC Drugs / William E. Gilbertson, Steven A. Francesco375
Pt. VEffective Methodology in Expediting NDA Approval 
 18Industry and FDA Liaison / William M. Troetel393
 19Data Presentation for FDA Submissions: Text and Tabular Exposition / Patricia Blaine415
 20The Computer World in New Drug Development / Chris Clauss423
 21Working with a CRO / Duane B. Lakings, Alexandra D. J. Mancini439
 22The Evolving SMO in the United States / Kenneth A. Getz455
 Index465


If you experience difficulty accessing or navigating this content, please contact the OPAL Support Team