Availability Standardization and Safety of Human Cells and Tissues for Drug Screening and Testing 231

Glyn N. Stacey and Thomas Hartung

9.1 Introduction 231

9.2 Availability of Human Cells and Tissues for In-Vitro Testing 231

9.2.1 Selecting a Cell-Based System 231

9.2.1.1 Considering the Options for Human Cell-Based Testing 231

9.2.1.2 Establishing a Method Based on an Existing Human Cell Line 232

9.2.1.3 Developing New or Improved Cell Line-Based Techniques 233

9.2.2 Using Donated Human Tissue 233

9.3 Standardization of Cells and Tissues for Testing Purposes 237

9.3.1 Standardization of Primary Cells and Tissues 237

9.3.2 Standardization of Cell Lines 238

9.3.2.1 Challenges for Standardization of Cell Lines 238

9.3.2.2 Achieving Standardization of Cell Lines 239

9.4 Safety Issues 242

9.4.1 Hazards Associated with Human Cells and Tissues 242

9.4.2 Risks from Cell Lines 243

9.5 The Validation of Cell- and Tissue-Based Assays 243

9.6 Conclusions and Future Prospects 245 References 246

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