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What should a clinical pharmacologist know to start a clinical trial? Zuckschwerdt Verlag, Munich, 1998. De Vocht A. SPSS basic guide book. Bijleveld Press, Amsterdam, 1998. Hays WL. Statistics. Holt, Rine and Winston, Toronto, Ontario, 1988. Kirkwood BR. Medical statistics. Blackwell Scientific Publications, Boston, MA, 1990. Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science, London, UK, 2000. Riffenburgh RH. Statistics in Medicine. Academic Press. New York, USA, 1999. Utts JM.

The final digits are found by a technique called “tightening the data”. 9. 8,etc. It will take more than a few minutes to find out the closest estimate of 5 in three digits.. S. Government’s Work Project Administration by hundreds of women during the economic depression in the 1930s. 22 CHAPTER 2 4. UNPAIRED T-TEST So far, we assessed a single mean versus 0, now we will assess two means versus each other. For example, a parallel-group study of two groups tests the effect of two beta-blockers on cardiac output.

High Yield Statistics. Lippincott, Williams & Wilkins Baltimore, Maryland, 2001. Petrie A, Sabin C. Medical Statistics at a Glance. Blackwell Science. Malden, MA, 2000. Lu Y, Fang JQ. Advanced Medical Statistics. World Scientific, River Edge, NJ,2003. Riegelman RK. Studying a study and testing a test. Lippincott Williams & Wilkins, 5th Edition, Philadelphia, 2005. CHAPTER 3 THE ANALYSIS OF SAFETY DATA OF DRUG TRIALS 1. INTRODUCTION, SUMMARY DISPLAY As discussed in chapter 1 the primary object of clinical trials of new drugs is generally to demonstrate efficacy rather than safety.

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