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First of all, we need to consider that the samples we analyse are just that: samples that should represent something bigger, such as the process, the ...

Guidelines ICH Q2 and ICH Q14 specify that robustness testing is part of method development, although many companies make it part of the method valida...

I fully underline the previous answer, and you can also bring it back to a simpler question: if you do not know what the purpose of the method will be...

In addition to the previous answer: the so-called sponsor, the license-holding pharmaceutical company, has the overall responsibility for the quality ...

By the number of vies, this is an important topic. However, we also see no responses so far, perhaps indicating the question is too general. Could you...