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Record Nr. |
UNINA9910455072803321 |
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Titolo |
Clinical trials handbook [[electronic resource] /] / edited by Shayne Cox Gad |
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Pubbl/distr/stampa |
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Hoboken, NJ, : Wiley, c2009 |
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ISBN |
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1-282-36844-3 |
9786612368448 |
0-470-46636-7 |
0-470-46635-9 |
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Descrizione fisica |
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1 online resource (1247 p.) |
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Collana |
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Pharmaceutical Development Series ; ; v.8 |
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Altri autori (Persone) |
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Disciplina |
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Soggetti |
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Drugs - Testing |
Clinical trials |
Electronic books. |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Clinical Trials Handbook; Contents; Preface; Contributors; 1 Introduction to Clinical Trials; 2 Regulatory Requirements for Investigational New Drug; 3 Preclinical Assessment of Safety in Human Subjects; 4 Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies; 5.1 History of Clinical Trial Development and the Pharmaceutical Industry; 5.2 Adaptive Research; 6 Organization and Planning; 7 Process of Data Management; 8 Clinical Trials Data Management; 9.1 Clinical Trials and the Food and Drug Administration; 9.2 Phase I Clinical Trials; 9.3 Phase II Clinical Trials |
9.4 Designing and Conducting Phase III Studies9.5 Phase IV: Postmarketing Trials; 9.6 Phase IV and Postmarketing Clinical Trials; 9.7 Regulatory Approval; 9.8 New Paradigm for Analyzing Adverse Drug Events; 10.1 Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent; 10.2 Clinical Trials Involving Oral Diseases; 10.3 Dermatology Clinical Trials; 10.4 Emergency Clinical Trials; 10.5 Gastroenterology; 10.6 Gynecology Randomized Control Trials; 10.7 |
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Special Population Studies (Healthy Patient Studies); 10.8 Musculoskeletal Disorders; 10.9 Oncology |
10.10 Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration10.11 Paediatrics; 10.12 Clinical Trials in Dementia; 10.13 Clinical Trials in Urology; 10.14 Clinical Trials on Cognitive Drugs; 10.15 Bridging Studies in Pharmaceutical Safety Assessment; 10.16 Brief History of Clinical Trials on Viral Vaccines; 11 Methods of Randomization; 12 Randomized Controlled Trials; 13 Cross-Over Designs; 14.1 Biomarkers; 14.2 Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis; 15 Review Boards |
16 Size of Clinical Trials17 Blinding and Placebo; 18 Pharmacology; 19 Modeling and Simulation in Clinical Drug Development; 20 Monitoring; 21 Inference Following Sequential Clinical Trials; 22 Statistical Methods for Analysis of Clinical Trials; 23 Explanatory and Pragmatic Clinical Trials; 24.1 Ethics of Clinical Research in Durg Trials; 24.2 Ethical Issues in Clinical Research; 25 Regulations; 26 Future Challenges in Design and Ethics of Clinical Trials; 27 Proof-of-Principle/Proof-of-Concept Trials in Drug Development; Index |
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Sommario/riassunto |
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Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of |
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2. |
Record Nr. |
UNINA9910213828003321 |
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Autore |
Satō Ryūzō <1931-> |
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Titolo |
The chrysanthemum and the eagle : the future of U.S.-Japan relations / / Ryuzo Sato |
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Pubbl/distr/stampa |
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New York, NY : , : New York University Press, , [1994] |
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©1994 |
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ISBN |
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9780814788707 |
081478870X |
9780585274287 |
0585274282 |
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Descrizione fisica |
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1 online resource (242 p.) |
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Disciplina |
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Soggetti |
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BUSINESS & ECONOMICS / International / General |
United States Relations Japan |
Japan Relations United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Front matter -- CONTENTS -- PREFACE -- ONE. THE RISE OF REVISIONISM -- TWO. CONFLICTING VIEWS OF THE ROLE OF GOVERNMENT -- THREE. THE ANATOMY OF U.S.-JAPANESE ANTAGONISMS -- FOUR. IN SOME WAYS JAPAN REALLY IS ODD -- FIVE. IS A PAX JAPONICA POSSIBLE? -- SIX. JAPAN'S FUTURE COURSE -- SELECTED BIBLIOGRAPHY -- INDEX |
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Sommario/riassunto |
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Whether in the form of the ongoing automotive wars, books and films such as Michael Crichton's Rising Sun, or George Bush's ill-fated trip to Japan in 1991, frictions between the United States and Japan have been steadily on the rise. Americans are bombarded with images of Japan's fundamental difference; at the same time, voices in Japan call for a Japan That Can Say No. If the guiding principle of the Clinton administration is indeed new values for a new generation, how will this be reflected in U.S.-Japanese relations?Convinced that no true solution to U.S.-Japanese frictions can be achieved without tracing these frictions back to their origin, Ryuzo Sato here draws on a binational experience that spans three decades in both the Japanese and |
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American business and academic communities to do just that. In an attempt to bridge the communication gap between the two countries and dispel some of the mutual ignorance and misunderstanding that prevails between the two, Sato addresses the following questions: --Is Japan really different? --Has America's sun set?--How have conflicting views on the role of government affected U.S.-Japan relations?--What are the real differences in American and Japanese industrial policies?--What is the anatomy of U.S.-Japanese antagonisms?--What effect has the collapse of the bubble economy had on relations?--What is Japan's future course? Is it truly a technological superpower? Can it avoid international isolation? An incisive personal look at one of the most important political and economic global relationships, written by a major player in the world of international business and finance, THE CHRYSANTHEMUM AND THE EAGLE provides a readable and engaging tour of U.S.-Japan relations, past and present. |
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