Tag: In vivo studies

BA-BE Studies: SOP for Column Performance Qualification – V 2.0 Standard Operating Procedure for Column Performance Qualification in BA/BE LC-MS/MS Analysis Department BA-BE Studies SOP No. SOP/BA-BE/190/2025 Supersedes SOP/BA-BE/190/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for qualification and monitoring of…

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BA-BE Studies: SOP for Use of Internal Standards in LC-MS/MS – V 2.0 Standard Operating Procedure for Use of Internal Standards in LC-MS/MS Analysis for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/189/2025 Supersedes SOP/BA-BE/189/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To describe the…

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BA-BE Studies: SOP for Audit Trail Review in Bioanalytical Software – V 2.0 Standard Operating Procedure for Audit Trail Review in Bioanalytical Software for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/188/2025 Supersedes SOP/BA-BE/188/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a consistent…

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BA-BE Studies: SOP for Reproducibility Assessment Across Runs – V 2.0 Standard Operating Procedure for Reproducibility Assessment Across Analytical Runs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/187/2025 Supersedes SOP/BA-BE/187/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a standardized procedure for assessing…

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BA-BE Studies: SOP for Backup and Archiving of Analytical Data – V 2.0 Standard Operating Procedure for Backup and Archiving of Analytical Data in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/186/2025 Supersedes SOP/BA-BE/186/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure…

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BA-BE Studies: SOP for Data Integrity in Bioanalytical Labs – V 2.0 Standard Operating Procedure for Ensuring Data Integrity in Bioanalytical Laboratories during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/185/2025 Supersedes SOP/BA-BE/185/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a comprehensive procedure…

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BA-BE Studies: SOP for Preventive Maintenance of Analytical Instruments – V 2.0 Standard Operating Procedure for Preventive Maintenance of Analytical Instruments in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/184/2025 Supersedes SOP/BA-BE/184/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for the…

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BA-BE Studies: SOP for Handling Analytical Equipment Breakdowns – V 2.0 Standard Operating Procedure for Handling Analytical Equipment Breakdowns in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/183/2025 Supersedes SOP/BA-BE/183/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a structured process for managing analytical…

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BA-BE Studies: SOP for Reinjection of Samples – V 2.0 Standard Operating Procedure for Reinjection of Samples in BA/BE Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/182/2025 Supersedes SOP/BA-BE/182/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To describe the procedure and controls associated with the…

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BA-BE Studies: SOP for Dilution Integrity Testing – V 2.0 Standard Operating Procedure for Dilution Integrity Testing in BA/BE Bioanalytical Validation Department BA-BE Studies SOP No. SOP/BA-BE/181/2025 Supersedes SOP/BA-BE/181/2022 Page No. Page 1 of 8 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for evaluating dilution integrity during…

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