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药品开发,固体口服剂型第二版 458条(本栏目收费,不能显示细节,电话13136136841)
Wet Granulation........112
112
Roller Compaction.....115
115
FDA Inspection.....163
163
OOS Investigation.....165
165
Annual Product Review......165
165
Field Complaint......166
166
Stability Software........166
166
Computer Validation......166
166
21 CFR Part 11......167
167
Value of Stability........167
167
Cost of Stability.....167
167
Conclusions........168
168
Documentation.......174
174
Optimization of Process Parameters and Justification of In-Process Specifications.........174
174
Development Reports or Logs.....176
176
Preapproval Inspections.........177
177
QA Involvement in R&D.......178
178
Acknowledgments.......181
181
Chapter 6 Drug Stability......139
139
Chapter 7 Quality Control and Quality Assurance......171
171