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This edited book brings together statistical methods in all nonclinical areas of pharma/biotech industries and promote nonclinical statistics as a discipline. In the last Nonclinical Statistical Leadership Forum, nonclinical group leaders from different companies unanimously agreed that nonclinical statistics falls far behind clinical statistics in impacting these industries. One suggestion for improvement is to get more academic people involved so that more students will do research and pursue career in nonclinical statistics. A comprehensive statistical methodology book with essential scientific background will help to stimulate academic interest, provide a handy manual for entry level statisticians, a good reference for regulatory, industry and academic professionals.