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Pt. A General Concepts 1
1 Introduction 3
2 Nomenclature and General Concepts 27
3 Extractables, Leachables, and the Product Life Cycle 77
Pt. B Material Characterization 89
4 Material Screening and Characterization 91
Pt. C Construct Qualification 157
5 The Prototype Stage 159
6 The Early Development Stage 191
Pt. D Construct Validation 229
7 Late Stage Product Development 231
8 Submission 249
9 Launch 265
Pt. E Product Maintenance 271
10 Product Maintenance 273
11 Retirement 315
12 Focus on Emerging Concepts 319
Appendix Materials Used in Pharmaceutical Constructs and Their Associated Extractables 347
Index 371
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