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Determine impurity level in relevant batchesDetermine mean + upper con Determine impurity level in relevant batchesDetermine mean + upper con

Determine impurity level in relevant batchesDetermine mean + upper con - PDF document

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Uploaded On 2016-03-11

Determine impurity level in relevant batchesDetermine mean + upper con - PPT Presentation

DECISION TREE 1 ESTABLISHING ACCEPTANCE CRITERION FOR A SPECIFIED IMPURITY IN A NEW DRUG SUBSTANCE Relevant batches are those from development pilot and scaleup studiesRefer to ICH Guideline on I ID: 252130

DECISION TREE #1: ESTABLISHING ACCEPTANCE

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