SOPs for BA-BE Studies V 2.0

To define a standardized procedure for the secure handling, retrieval, and archiving of raw data files generated from LC-MS/MS instruments during bioanalytical runs in BA/BE studies.
Click to read the full article.

To establish a standard procedure for the review and acceptance of calibration curves and quality control (QC) samples generated during LC-MS/MS analysis in bioavailability and bioequivalence (BA/BE) studies.
Click to read the full article.

To outline the procedure for evaluating the stability of analytes in plasma samples under various conditions to ensure the integrity of study samples analyzed during bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To define the process for conducting freeze-thaw stability studies for plasma samples to assess the effect of multiple freezing and thawing cycles on analyte concentration in bioavailability and bioequivalence (BA/BE) studies.
Click to read the full article.

To define the procedure for conducting short-term stability studies of analytes in plasma to ensure sample integrity during temporary exposure to room temperature conditions during sample processing in bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To define the process for assessing the long-term stability of analytes in plasma samples stored at -20°C and/or -70°C over extended periods as part of bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To define the procedure for evaluating bench-top stability of analytes in plasma under ambient temperature conditions during sample preparation and handling, in support of bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To define the process for evaluating the auto-sampler stability of analytes in processed plasma samples stored in the instrument tray during LC-MS/MS runs in bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To describe the procedure for evaluating the matrix effect during method validation of bioanalytical assays, particularly LC-MS/MS-based quantification methods used in bioavailability/bioequivalence (BA/BE) studies.
Click to read the full article.

To define a standardized procedure for evaluating the selectivity and sensitivity of analytical methods used in bioavailability/bioequivalence (BA/BE) studies for accurate quantification of analytes in biological matrices.
Click to read the full article.