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Editorial Board
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CO2
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Risk management and post-marketing surveillance of CNS drugs: An introduction
We are pleased to introduce this supplemental issue of Drug and Alcohol Dependence that focuses on contemporary approaches to risk management and post-marketing surveillance of drugs acting on the cen...
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Robert L. Balster,
Chris-Ellyn Johanson,
Sharon L. Walsh
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S1-S3
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Introduction to College on Problems of Drug Dependence special conference on risk management and post-marketing surveillance of CNS drugs
The College on Problems of Drug Dependence (CPDD) special conference on risk management and post-marketing surveillance was convened to develop recommendations concerning the state of the science, res...
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Charles R. Schuster,
Andrea G. Barthwell,
Jack E. Henningfield
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S4-S8
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Risk management of drug products and the U.S. Food and Drug Administration: Evolution and context
Abstract: This paper summarizes the background and origins of pharmaceutical risk management and minimization principles and approaches as reflected in FDA statute, policy, and practice. It describes ...
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Deborah B. Leiderman
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S9-S13
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Principles of laboratory assessment of drug abuse liability and implications for clinical development
Abstract: Abuse liability testing plays an important role in informing drug development, regulatory processes, and clinical practice. This paper describes the current “gold standard” methodologies tha...
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Lawrence P. Carter,
Roland R. Griffiths
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S14-S25
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Monitoring risk: Post marketing surveillance and signal detection
Abstract: The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveil...
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Richard C. Dart
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S26-S32
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Signal detection in post-marketing surveillance for controlled substances
Abstract: Signal detection for pharmaceutical controlled substances presents unique challenges compared to other pharmacovigilance programs because risks are present in the patient and non-patient pop...
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Nabarun Dasgupta,
Sidney H. Schnoll
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S33-S41
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Case histories in pharmaceutical risk management
Abstract: The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Adminis...
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Cynthia G. McCormick,
Jack E. Henningfield,
J. David Haddox,
Sajan Varughese,
Anders Lindholm,
Susan Rosen,
Janne Wissel,
Deborah Waxman,
Lawrence P. Carter,
Vickie Seeger,
Rolley E. Johnson
et al.
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S42-S55
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Risk management and post-marketing surveillance of CNS drugs
Abstract: Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-...
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Jack E. Henningfield,
Charles R. Schuster
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S56-S64
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Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: Expert Panel Report
Abstract: The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk ma...
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Chris-Ellyn Johanson,
Robert L. Balster,
Jack E. Henningfield,
Charles R. Schuster,
James C. Anthony,
Andrea G. Barthwell,
John J. Coleman,
Richard C. Dart,
Charles W. Gorodetzky,
Charles O’Keeffe,
Edward M. Sellers,
Frank Vocci,
Sharon L. Walsh
et al.
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S65-S71
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