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Test Bank For Sterile Product Development Formulation, Process, Quality and Regulatory Considerations 2
Sterile Product Development
Sterile Product Development
1.1 Introduction This chapter presents an overview of the basic approach to formulation development of sterile products. Later chapters will present more detailed consideration of the concepts introduced in this chapter. In general, the development of a sterile product requires that certain studies be carried out regardless of the type of product, be it an intravenous, intramuscular, subcutaneous, intrathecal, intra-articular, ophthalmic, or inhalation product. The required studies are virt...
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