Tag: Pharmacokinetics

BA-BE Studies: SOP for Review of Instrument Calibration Logs – V 2.0 Standard Operating Procedure for Review of Instrument Calibration Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/200/2025 Supersedes SOP/BA-BE/200/2022 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 reviewing…

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BA-BE Studies: SOP for Analyst Proficiency Testing – V 2.0 Standard Operating Procedure for Analyst Proficiency Testing in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/199/2025 Supersedes SOP/BA-BE/199/2022 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 procedure for evaluating and documenting the technical…

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BA-BE Studies: SOP for Change Control in Bioanalytical Method – V 2.0 Standard Operating Procedure for Change Control in Bioanalytical Method in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/198/2025 Supersedes SOP/BA-BE/198/2022 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 standardized approach for…

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BA-BE Studies: SOP for Batch Rejection and Repeat Analysis – V 2.0 Standard Operating Procedure for Batch Rejection and Repeat Analysis in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/197/2025 Supersedes SOP/BA-BE/197/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose This SOP outlines the systematic procedure…

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BA-BE Studies: SOP for Run Acceptance Criteria and Review – V 2.0 Standard Operating Procedure for Run Acceptance Criteria and Review in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/196/2025 Supersedes SOP/BA-BE/196/2022 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 the acceptance criteria for…

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BA-BE Studies: SOP for Ensuring Sample Integrity Before Analysis – V 2.0 Standard Operating Procedure for Ensuring Sample Integrity Before Bioanalytical Analysis in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/195/2025 Supersedes SOP/BA-BE/195/2022 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 procedures to…

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BA-BE Studies: SOP for Documentation of Sample Storage Conditions – V 2.0 Standard Operating Procedure for Documentation of Sample Storage Conditions in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/194/2025 Supersedes SOP/BA-BE/194/2022 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 documenting…

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BA-BE Studies: SOP for Logging Receipt of Samples from Clinical Site – V 2.0 Standard Operating Procedure for Logging Receipt of Samples from Clinical Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/193/2025 Supersedes SOP/BA-BE/193/2022 Page No. Page 1 of 8 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish…

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BA-BE Studies: SOP for Disposal of Used Biological Samples – V 2.0 Standard Operating Procedure for Disposal of Used Biological Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/192/2025 Supersedes SOP/BA-BE/192/2022 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 the…

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BA-BE Studies: SOP for Verification of Mobile Phase Composition – V 2.0 Standard Operating Procedure for Verification of Mobile Phase Composition in BA/BE LC-MS/MS Analysis Department BA-BE Studies SOP No. SOP/BA-BE/191/2025 Supersedes SOP/BA-BE/191/2022 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 standard procedure…

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