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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)
Development of a Validation Protocol........42
42
Validation Planning and Protocol Execution......46
46
Instrumentation Selection.........46
46
Standards Qualification and Handling.......47
47
Optimization of the Experimental Sequence for Efficiency........47
47
Resources and Timelines.......47
47
Validation Report.....47
47
Method Equivalency Study........47
47
Method Transfer........48
48
Objective of the Method Transfer........48
48
Documentation of Method Transfer.....48
48
Method Transfer Protocol......48
48
Method Transfer Report.......48
48
Additional Validation and Revalidation of the Test Method......49
49
Summary and Conclusions.........49
49
Introduction........52
52
Formulation Development Strategies.........54
54
Patent Search(es)........54
54
Formulation Patents.....54
54
Combination Patents....54
54
Granulation Properties........102
102
Drying Properties.......102
102
Compaction Behavior.........102
102
Potential Changes during Storage......102
102
Formulation Design and Process Development Optimization......103
103
QbD in Generic Product Development.....103
103
Design of Experiments (DOEs).......105
105
Scale-Up Characterization of Manufacturing Process......108
108
Dry Blending..........110
110