SOPs for BA-BE Studies V 2.0

To define a structured and compliant process for the development of bioanalytical methods used to quantify drug substances and metabolites in biological matrices, supporting bioavailability/bioequivalence (BA/BE) studies.
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To define a detailed and standardized approach for the validation of bioanalytical methods used in the quantification of analytes in biological matrices, ensuring compliance with the International Council for Harmonisation (ICH) M10 guidelines.
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To outline the procedure for preparation, handling, storage, and application of calibration standards used in the quantification of analytes in bioanalytical studies, ensuring accuracy and compliance with regulatory guidelines.
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To define the process for preparation, labeling, storage, and use of Quality Control (QC) samples in bioanalytical methods supporting pharmacokinetic and bioequivalence (BA/BE) studies, ensuring accuracy and regulatory compliance.
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To define the controlled procedure for thawing and equilibrating biological samples (plasma, serum, urine) before sample processing and analysis in bioanalytical laboratories supporting BA/BE studies.
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To define the detailed procedure for extracting analytes from human plasma samples prior to LC-MS/MS or other analytical quantification in bioanalytical labs supporting BA/BE studies.
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To outline the procedure for performing Solid Phase Extraction (SPE) for the isolation and concentration of analytes from biological matrices such as plasma or serum during BA/BE studies.
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To define the procedure for conducting liquid-liquid extraction (LLE) to isolate analytes from biological matrices like plasma or serum for subsequent analysis in BA/BE studies.
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To establish a standard procedure for the extraction of analytes from plasma samples using the protein precipitation method for bioanalytical sample preparation in BA/BE studies.
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To define the standard procedure for using Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) for the quantification of drug compounds and metabolites in biological matrices during BA/BE studies.
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