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Method Validation in Pharmaceutical Analysis [2014]

1
Analytical Validation within the Pharmaceutical Lifecycle
11
Analytical Instrument Qualification
41
Establishment of Measurement Requirements – Analytical Target Profile and Decision Rules
59
Establishment of Measurement Requirements – Performance‐Based Specifications
73
Method Performance Characteristics
191
Method Design and Understanding
303
Method Performance Qualification
377
Continued Method Performance Verification
411
Index
I
Front Matter
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