Plan development program creation

For those who desigii/ track/ and make decisions regarding the progress of clinical development programs/ the inclusion within the development plan of critical decision pointS/ with prespecified go/no-go criteria/ provides a focus for the clinical development team. The key clinical drug development decisions are identified in Table 33.2/ with the critical go/no-go decisions being shown in boldface. These critical decisions will be expanded on later in this chapter. It is important to note that the driver for these decisions is our question-based label-driven clinical development plan. Indeed/ the creation of a label-driven question-based clinical development plan not only increases the efficiency and speed of the clinical development process/ but also supports the question-based review by the FDA of an NDA/ as described by Lesko and Williams (35). 

This book was developed to provide safety and health professionals, students, and employers with the basic tenets for the creation of an occupational safety and health initiative for those responsible or planning to implement and manage safety and health programs for their companies or future employers. The intent of this book is to provide a management blueprint for occupational safety and health for the smallest to the largest companies who are beginning to or have seen the need to develop or improve their safety and health approach in their workplace. This would include the construction industry as well as other industrial groups. 

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