Coordinating Clinical Trials In Psychopharmacology

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Clinical Trials in Psychopharmacology

Author : Marc Hertzman,Lawrence Adler
Publisher : John Wiley & Sons
Page : 406 pages
File Size : 50,7 Mb
Release : 2010-03-16
Category : Medical
ISBN : 0470749172

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Clinical Trials in Psychopharmacology by Marc Hertzman,Lawrence Adler Pdf

Although clinical trials were virtually unheard of in psychiatry for many years, they are now the gold standard for judging whether drugs are safe and useful. But should they be? What is the true status of clinical trials? Even when they ostensibly demonstrate a benefit of a certain treatment, the strict patient selection criteria, poor compliance and high drop-out rate leave the conclusions open to question. Are the new treatments really better or more cost-effective than the old? Do they have fewer side effects? In this book the authors take a critical look at recent developments and present a series of trenchant and challenging observations. Section I examines the significant changes in law and the regulatory environment that have occurred during the past ten years. Has fossilization handicapped the US Food and Drug Administration in promoting treatment advances? How can the plethora of findings be regulated? This is particularly pertinent in genomic studies and there are two chapters addressing the impact of genomics on psychiatric research. This section also addresses the role of women in drug trials – a group long excluded but now demanding a part, for without testing how can optimal treatments be devised? The next two Sections highlight clinical trials in the major areas of psychiatric pharmacological treatment, including Mood Disorders, especially Bipolar, Anxiety Disorders, and addictions. Chapters on pharmacological treatments for Eating Disorders, Attention Deficit Disorder, Autism and Asperger’s Syndrome, and Impulse Control Disorder represent the latest thinking on these subjects. The final Section contains a consummate example of out-of-the [Western]- box thinking, namely consideration of herbal medicines – used by a large number of patients, with or without medical supervision. We conclude with a close look at the problem of side effects, then selected thoughts about methodology. Clearly written, the text provides immediate access to new developments across the spectrum of drug testing. Clinical Trials in Psychopharmacology: A Better Brain is provocative reading for psychiatrists, pharmacologists and all those interested in improved drug treatments for patients with mental illness. Raises questions about the conduct of trials and the credibility of their outcomes that are relevant not just in psychiatry but all areas of medicine Discusses the ethical problems in assessing outcomes in humans, including children

Psychopharmacology Abstracts

Author : Anonim
Publisher : Unknown
Page : 754 pages
File Size : 47,9 Mb
Release : 1981
Category : Psychopharmacology
ISBN : IND:30000090368659

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Psychopharmacology Abstracts by Anonim Pdf

Methodology of the Evaluation of Psychotropic Drugs

Author : Otto Benkert,Wolfgang Maier,Karl Rickels
Publisher : Springer Science & Business Media
Page : 175 pages
File Size : 55,6 Mb
Release : 2012-12-06
Category : Medical
ISBN : 9783642753701

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Methodology of the Evaluation of Psychotropic Drugs by Otto Benkert,Wolfgang Maier,Karl Rickels Pdf

The idea of placebo-controlled drug trials and the advent of test statistics during the first part of this century were the major milestones in the establishment of a convincing methodology for demonstrating the efficacy of treatments. The first tricyclic and neuroleptic drugs were tested for their efficacy in psychiatric disorders along the lines of these methodological developments, but subsequent trials with psychotropic drugs did not adhere to these principles to the same extent because it became difficult to justify placebo-controlled trials once effective treatments had been established. Consequently, the second generation of an tidepressants and neuroleptics (since the early 1960s) were mainly tested, in Europe at least, in samples of patients using trials controlled by standard treatment only, and the methodological basis of these second generation trials became fragile, as will be demonstrated by several papers in this book. This development did not provoke much discussion until recently, when scientific and administrative interest in the methodology of the evaluation of psychotropic drugs increased substantially. A series of factors contribute to the growing interest in the standards of psychotropic drug trials: 1. The proportion of psychiatric patients resistant to treatment is growing; the efficacy of well-established forms of treatment therefore seems to be limited. 2. A series of psychotropic drugs were withdrawn from the market, mainly because they caused serious side effects. The efficacy and safety ofthese drugs had previously been demonstrated in drug trials, which raised the question whether the drug trials carried out were well-designed.

Statistical Methodology in the Pharmaceutical Sciences

Author : D. A. Berry
Publisher : CRC Press
Page : 592 pages
File Size : 53,9 Mb
Release : 2016-04-19
Category : Mathematics
ISBN : 9781482276862

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Statistical Methodology in the Pharmaceutical Sciences by D. A. Berry Pdf

A state-of-the-art handbook of statistical analysis for use in the pharmaceutical industry. Areas covered in this reference/text include: bioavailability, repeated-measures designs, dose-response, population models, multicenter trials, handling dropouts, survival analysis, robust data analysis, cate

Interagency Coordination in Drug Research and Regulation

Author : United States. Congress. Senate. Committee on Government Operations
Publisher : Unknown
Page : 1648 pages
File Size : 42,9 Mb
Release : 1964
Category : Drugs
ISBN : MINN:319510001092227

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Interagency Coordination in Drug Research and Regulation by United States. Congress. Senate. Committee on Government Operations Pdf

Interagency Coordination in Drug Research and Regulation

Author : United States. Congress. Senate. Committee on Government Operations. Subcommittee on Reorganization and International Organizations
Publisher : Unknown
Page : 2010 pages
File Size : 44,8 Mb
Release : 1963
Category : Drugs
ISBN : MINN:31951D02159147Z

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Interagency Coordination in Drug Research and Regulation by United States. Congress. Senate. Committee on Government Operations. Subcommittee on Reorganization and International Organizations Pdf

Reviews cooperative efforts among Federal and international agencies responsible for medical research on experimental drugs and regulation of pharmaceutical industry marketing practices. Includes review of thalidomide marketing and use.

Interagency Coordination in Drug Research and Regulation: Testimony and exhibits (including subsequent correspondence) on specialized drugs and drug problems: 1) drugs for mental illness; 2) antibiotics; 3) drug testing; 4) neonatal pharmacology; and 5) communication on drug emergencies

Author : United States. Congress. Senate. Committee on Government Operations
Publisher : Unknown
Page : 924 pages
File Size : 50,9 Mb
Release : 1964
Category : Drugs
ISBN : OSU:32437122474246

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Interagency Coordination in Drug Research and Regulation: Testimony and exhibits (including subsequent correspondence) on specialized drugs and drug problems: 1) drugs for mental illness; 2) antibiotics; 3) drug testing; 4) neonatal pharmacology; and 5) communication on drug emergencies by United States. Congress. Senate. Committee on Government Operations Pdf

Reviews cooperative efforts among Federal and international agencies responsible for medical research on experimental drugs and regulation of pharmaceutical industry marketing practices. Includes review of thalidomide marketing and use, drugs for mental illness, neonatal pharmacology, etc.

Publication Catalog of the U.S. Department of Health and Human Services

Author : United States. Department of Health and Human Services
Publisher : Unknown
Page : 516 pages
File Size : 50,7 Mb
Release : 2024-06-30
Category : Government publications
ISBN : STANFORD:36105219361263

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Publication Catalog of the U.S. Department of Health and Human Services by United States. Department of Health and Human Services Pdf

Publication Catalog of the U. S. Department of Health, Education and Welfare

Author : United States. Dept. of Health, Education, and Welfare
Publisher : Unknown
Page : 518 pages
File Size : 54,7 Mb
Release : 1979
Category : Government publications
ISBN : UOM:39015035387060

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Publication Catalog of the U. S. Department of Health, Education and Welfare by United States. Dept. of Health, Education, and Welfare Pdf

Interagency Coordination in Drug Research and Regulations

Author : United States. Congress. Senate. Government Operations
Publisher : Unknown
Page : 924 pages
File Size : 50,6 Mb
Release : 1962
Category : Electronic
ISBN : STANFORD:36105117867031

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Interagency Coordination in Drug Research and Regulations by United States. Congress. Senate. Government Operations Pdf

Clinical Evaluation of Psychotropic Drugs

Author : Robert F. Prien,Donald S. Robinson,National Institute of Mental Health (U.S.),American College of Neuropsychopharmacology
Publisher : Raven Press (ID)
Page : 760 pages
File Size : 54,8 Mb
Release : 1994
Category : Medical
ISBN : UOM:39015032611132

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Clinical Evaluation of Psychotropic Drugs by Robert F. Prien,Donald S. Robinson,National Institute of Mental Health (U.S.),American College of Neuropsychopharmacology Pdf

A source book in clinical methods for the understanding of psycho- pharmacologic agents and clinical evaluation of drugs in the treatment of mental disorder, produced in association with the National Institute of Mental health and the American College of Neuropsychopharmacology. The volume consists of three main sections. The first addresses the historical context of clinical psychopharmacologic research and guidelines and the decision process involved in drug development and evaluation. Section II addresses broad developments and issues for clinical methodology, providing guidance in research principles, study design and implementation, reporting of study findings, and ethical considerations involving drug evaluations. Section III provides methodologic developments and recommendations for research involving specific patient populations. Annotation copyright by Book News, Inc., Portland, OR

Research in the Service of Mental Health

Author : National Institute of Mental Health (U.S.). Research Task Force
Publisher : Unknown
Page : 472 pages
File Size : 54,6 Mb
Release : 1975
Category : Government publications
ISBN : UIUC:30112104131955

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Research in the Service of Mental Health by National Institute of Mental Health (U.S.). Research Task Force Pdf