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Method Validation

Abpharm can plan your analytical method validation according to regulatory requirements (ICH guidelines).

Initially we make an assessment of the method type, sample type and concentration and the expectations of the method.  We will review exploratory data generated by the method and will prepare a validation protocol with appropriate acceptance criteria for each parameter.  The protocol will lay out in a simple terms the actual experiments that will be conducted and will be formatted such that it can easily be turned into the final report by changing to past tense and entering in results.

In most cases, additional work can be avoided by setting appropriate acceptance criteria in the protocol.  However, we will assess the results of the study and will advise if further investigations are required.