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15274084725)
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