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Bioanalytical Techniques Top Journal | Open Access Journals
Journal of Bioanalysis & Biomedicine

Journal of Bioanalysis & Biomedicine

ISSN: 1948-593X

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Bioanalytical Techniques Top Journal

Recently, there has been increased public awareness of drug safety around the world. The non-clinical and clinical pharmacokinetics and safety studies of toxic kinetic toxicology all require that the study samples be analyzed under the auspices of Good Laboratory Practice (GLP) standards. GLP is monitored to ensure that the safety studies are reliable and precise. Several countries have published or are in the process of publishing their own versions of the bioanalytical guidance documents for carrying out method validation activities; however, each is slightly different. These differences often make it difficult and constraining to comply with regulatory requirements. Several networking organizations have worked diligently to harmonize the various global bioanalytical guidance documents. This article attempts to shed light on some of the critical points to consider when carrying out the development of bioanalytical methods and validation activities that comply with GLP from the point of view of a scientist.

The ultimate goal of any study sample or method validation analysis, regardless of whether GLP compliance is applied or not, is to ensure that the bioanalytical methods used are tested by points to be considered from of several bioanalytical orientation references. Also presented are additional scientific points to consider when developing non-clinical and clinical LC-MS / MS bioanalysis methods.

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Citations: 3099

Journal of Bioanalysis & Biomedicine received 3099 citations as per Google Scholar report

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