Clinical Research and Regulatory Affairs, Volume 3, Issue 4 (1985)

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Clinical Research Practices and Drug Regulatory Affairs, Volume 3, Issue 4 (1985)

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Research Article

Article
Problems Encountered in Phase I Drug Development
Steven H. Grossman
Page: 401
Published online: 28 Sep 2008
CitationforProblems Encountered in Phase I Drug Development | PDF (43.9 KB)
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Article
Monitoring Adverse Events
Allen Cato, Jacques Caldwell, Janet Dickerson & Pat Russell
Page: 403
Published online: 28 Sep 2008
CitationforMonitoring Adverse Events | PDF (56 KB)
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Article
Clinical Research Process
Leigh Thompson
Pages: 405-406
Published online: 28 Sep 2008
CitationforClinical Research Process | PDF (76.3 KB)
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Article
Evaluation of Dependence Potential and Abuse Liability in Drug Development
Charles W. Gorodetzky
Pages: 407-408
Published online: 28 Sep 2008
CitationforEvaluation of Dependence Potential and Abuse Liability in Drug Development | PDF (62 KB)
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Article
Evaluation of New Neuromuscular Blocking Agents Volunteers and Patients
John J. Savarese
Pages: 409-410
Published online: 28 Sep 2008
CitationforEvaluation of New Neuromuscular Blocking Agents Volunteers and Patients | PDF (78 KB)
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Article
Fda's Plan for Action-1985 (Preparing for Drug Review in the 21st Century)
Charles W. Prettyman
Pages: 411-412
Published online: 28 Sep 2008
CitationforFda's Plan for Action-1985 (Preparing for Drug Review in the 21st Century) | PDF (73.3 KB)
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Article
A Perspective on the Guidelines for Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Rheumatology
Daniel E. Furst
Pages: 413-414
Published online: 28 Sep 2008
CitationforA Perspective on the Guidelines for Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Rheumatology | PDF (91.7 KB)
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Article
Strategies for Using Preclinical Safety Testing Effectively
George M. Szczech
Pages: 415-416
Published online: 28 Sep 2008
CitationforStrategies for Using Preclinical Safety Testing Effectively | PDF (67.3 KB)
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Article
Problems of Investigational New Drugs: Special Problems for the Investigator
Jacques R. Caldwell
Pages: 417-418
Published online: 28 Sep 2008
CitationforProblems of Investigational New Drugs: Special Problems for the Investigator | PDF (62.9 KB)
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Article
Using Profs to Manage Site Visit Reporting
Greg Boyer, Claudia Dixon, Sue Traub, Antonia Valakas, Barbara Stephens & Gilles Cloutier
Page: 421
Published online: 28 Sep 2008
CitationforUsing Profs to Manage Site Visit Reporting | PDF (59.2 KB)
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Article
The Investigator's Brochure as a Tool for the Development of the Package Insert
G. E. Collins, G. Cloutier & A. E. Cato
Page: 423
Published online: 28 Sep 2008
CitationforThe Investigator's Brochure as a Tool for the Development of the Package Insert | PDF (64.5 KB)
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Article
An Integrated Approach for Processing Drug Information Inquiries at the Time of a New Product Launch
G. E. Collins, G. Cloutier, C. S. Frieden & A. E. Cato
Page: 425
Published online: 28 Sep 2008
CitationforAn Integrated Approach for Processing Drug Information Inquiries at the Time of a New Product Launch | PDF (58.3 KB)
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Article
Unique Computer Programs to Assist in Clinical Trials Management
David D. Michie
Page: 427
Published online: 28 Sep 2008
CitationforUnique Computer Programs to Assist in Clinical Trials Management | PDF (59.7 KB)
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Article
Are we Assessing Patient Compliance?
Priscilla M. Brady & Joseph S. Alpert
Page: 429
Published online: 28 Sep 2008
CitationforAre we Assessing Patient Compliance? | PDF (57.9 KB)
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Article
Auditing of Clinical Trials
Sherrie L. Rosenzwog, Michael J. Hensley, James A. Bannon & John J. Schrogie
Page: 431
Published online: 28 Sep 2008
CitationforAuditing of Clinical Trials | PDF (62.3 KB)
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Article
An Effective Methodology for Investigator Selection
Frank L. Galasso, Judith Barton, Sheila Gilbride & Michael Morris
Page: 433
Published online: 28 Sep 2008
CitationforAn Effective Methodology for Investigator Selection | PDF (46.9 KB)
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Article
Design of a Functional Modular Case Report Form
Judith Barton, Hana Kosar & David Lester
Page: 435
Published online: 28 Sep 2008
CitationforDesign of a Functional Modular Case Report Form | PDF (45.4 KB)
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Article
The Conduct of Study Report: Assuring Quality of Data
Barbara A. Block
Page: 437
Published online: 28 Sep 2008
CitationforThe Conduct of Study Report: Assuring Quality of Data | PDF (56.1 KB)
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Article
Clinical Project Management: Coordination of Information Flow
Barbara Nagle, Jean Hosutt, Joseph McDevitt & George Moonsammy
Page: 439
Published online: 28 Sep 2008
CitationforClinical Project Management: Coordination of Information Flow | PDF (54.4 KB)
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Article
Factors Influencing Patient Evaluability in Anti-Infective Clinical Trials
Jean A. Hosutt, George I. Moonsammy, Joseph T. McDevitt, Barbara T. Nagle & Sean A. Reade
Pages: 441-442
Published online: 28 Sep 2008
CitationforFactors Influencing Patient Evaluability in Anti-Infective Clinical Trials | PDF (69.8 KB)
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Article
Data Management and Reporting of Clinical and Bacteriological data from Multicenter Antibiotic Clinical Trials
George I. Moonsammy, Joseph T. McDevitt, Jean A. Hosutt & Barbara T. Nagle
Page: 443
Published online: 28 Sep 2008
CitationforData Management and Reporting of Clinical and Bacteriological data from Multicenter Antibiotic Clinical Trials | PDF (63 KB)
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Article
Clinical Laboratory Data: Data Management and Reporting from Large Scale, Long-Term, Multicenter Trials
Joseph McDevitt, James McCafferty & Peter Zarevics
Page: 445
Published online: 28 Sep 2008
CitationforClinical Laboratory Data: Data Management and Reporting from Large Scale, Long-Term, Multicenter Trials | PDF (63.6 KB)
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Article
The Effect of Menstrual Cycle day on Uterine Motor Activity
A. Lusaitis, J. Dabice, J. R. Bianchine, S. B. Reele, R. Baldomero & B. Meghee
Pages: 447-448
Published online: 28 Sep 2008
CitationforThe Effect of Menstrual Cycle day on Uterine Motor Activity | PDF (72 KB)
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Article
The Nurse Clinical Research Associate in the Management of Clinical Trials
M. R. Ashworth, L. Cos, C. A. Seaman, K. E. Swisher & L. P. Whitley
Page: 449
Published online: 28 Sep 2008
CitationforThe Nurse Clinical Research Associate in the Management of Clinical Trials | PDF (51.1 KB)
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Article
Recruiting for Post-Operative Pain Studies: Experiences over two Years
Sarah E. Boyer, Cathy Viles, Philip T. Leese & Arthur E. Berger
Page: 451
Published online: 28 Sep 2008
CitationforRecruiting for Post-Operative Pain Studies: Experiences over two Years | PDF (58.4 KB)
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Article
Development of an Orientation Program for New Clinical Trial Monitors
David M. Cocchetto, Anne N. Stokley & Pamela S. Jones
Pages: 453-454
Published online: 28 Sep 2008
CitationforDevelopment of an Orientation Program for New Clinical Trial Monitors | PDF (66.6 KB)
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Article
Quantification of the Psychological Consequences after Commercial Introduction of a New Therapeutic Agent
Annette M. Lagreca, Wendy S. Citrin, Donna Giles & Albert A. Lauritano
Page: 455
Published online: 28 Sep 2008
CitationforQuantification of the Psychological Consequences after Commercial Introduction of a New Therapeutic Agent | PDF (62 KB)
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Article
Clinimetrics Research Project; Derivation of Scales to Enhance Patient Symptom/Side Effect Report
Carol Davidson
Pages: 457-458
Published online: 28 Sep 2008
CitationforClinimetrics Research Project; Derivation of Scales to Enhance Patient Symptom/Side Effect Report | PDF (85.4 KB)
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Article
Obligations of Investigators in Clinical Research a Pharmacist's Perspective
Randal L. Batenhorst
Pages: 459-476
Published online: 28 Sep 2008
AbstractforObligations of Investigators in Clinical Research a Pharmacist's Perspective | References | PDF (646.9 KB)
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Article
Clinical Research and the Geriatric Patient: An Assessment of Needs
Ronald B. Stewart
Pages: 477-500
Published online: 28 Sep 2008
AbstractforClinical Research and the Geriatric Patient: An Assessment of Needs | References | PDF (867.9 KB)
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Article
Biopharmaceutic Considerations in Designing and Evaluating Novel Drug Delivery Systems
Jerome P. Skelly & William H. Barr
Pages: 501-539
Published online: 28 Sep 2008
AbstractforBiopharmaceutic Considerations in Designing and Evaluating Novel Drug Delivery Systems | References | PDF (1.1 MB)
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Article
“Designer Genes and the Politics of Fear”
Donald Lerch
Pages: 541-547
Published online: 28 Sep 2008
Abstractfor“Designer Genes and the Politics of Fear” | References | PDF (309.5 KB)
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Erratum

Erratum
Page: 549
Published online: 28 Sep 2008
AbstractforErratum | PDF (29.3 KB)
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Research Article

Article
An Invitation from the Editor-In-Chief
Gary M. Matoren
Pages: ix-xi
Published online: 28 Sep 2008
First Page PreviewforAn Invitation from the Editor-In-Chief | PDF (101.8 KB)
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Article
Acknowledgement
Gary M. Matoren
Page: xiii
Published online: 28 Sep 2008
AbstractforAcknowledgement | PDF (26.4 KB)
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