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Manual for the Planning and Implementation of Therapeutic Studies (Paperback, Softcover reprint of the original 1st ed. 1983)
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Manual for the Planning and Implementation of Therapeutic Studies (Paperback, Softcover reprint of the original 1st ed. 1983)
Series: Lecture Notes in Medical Informatics, 20
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The German edition of this manual appeared in 1979. Its main
objective then was to extend help to those engaged in multiaentric
therapeutic studies, especially with respect to the "Federal
Government's Program on Promoting Research and Development in the
Service of Health". Experience with therapeutic studies in the
Federal Republic of Germany showed that considerable problems as to
methods and implementation of such studies exist. The manual was an
attempt to present current metho dological knowledge and the
experience obtained from completed studies in the light of the
international literature. No radically new methodo logy was
produced; however, the information representing the state-of the
art, which is widely scattered up to now, has been compiled. For
the American edition of this manual a few changes have been made.
These concern especially the literature where references to German
un published manuscripts were omitted. The authors wish to thank
Dr. Andreas Jaffe for the translation, and Evelyn Birke who
typewrited the lecture-notes manuscrip~ * . GUnzburg and Munich
Sibylle Biefang November 1981 Wolfgang Kopcke Martin A. Schreiber
Contents Page Foreword 1. Methods of Therapeutic Studies 2 1. 1.
Terminology 4 1. 2. Experimental Design 11 1. 3. Types of Studies
20 1. 4. Steps in Drug Testing 2. Checklist for the Planning,
Implementation and Evaluation 22 of Therapeutic Studies 22 2. 1.
Planning of Experiments 29 2. 2. Documentation 36 2. 3.
Organization 41 2. 4. Statistical Analysis 44 2. 5.
General
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