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Title New drug approval process : the global challenge / edited by Richard A. Guarino.
Imprint New York : Marcel Dekker, 2000.
Edition 3rd ed.

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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
 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

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