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