Validation of Methods and Procedures in Pharmacopoeial Monographs in the Framework of a Drug Standardization Program

Olefir, Yu. V.; Sakanyan, E. I.; Лутцева, А. И.; Babeshina, Larisa G.; Shemeryankina, T. B.

doi:10.1007/s11094-019-1919-5

Cited by 4 publications

(1 citation statement)

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“…The process of validation entails the execution of a set of analytical [19] tests and calculations to prove that the particular method is suitable for its purpose. Typical questions that should be answered during method validation [20] include.…”

Section: The International Conference Onmentioning

confidence: 99%

Method Adjustments, Changes, Revalidation and Verification of Standard and Compendial Methods

2023

IJBPAS

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The goal of any analytical measurement is to attain consistent, reliable, and accurate data. Validated analytical methods play a key role in achieving this goal. Most likely analytical methods have to be changed or altered at some stage in the life of the method. Sometimes method parameters may need modification back to their original specifications if the method is no longer meeting performance requirements. Method revision would also be necessary if the scope of a method modifies, such as the addition of new target compounds or a change of the sample matrix. The results from method validation can be used to judge the quality, reliability, and consistency of analytical results, which is an integral part of any good analytical practice. This review paper discusses method adjustments, changes, revalidation, verification of standard methods, and how method validation helps to achieve high-quality data.

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Section: The International Conference Onmentioning

confidence: 99%