Tag: Pharmacokinetics

BA-BE Studies: SOP for Emergency Protocol Activation – V 2.0 Standard Operating Procedure for Emergency Protocol Activation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/134/2025 Supersedes SOP/BA-BE/134/2022 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 a clear and effective procedure for the activation…

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BA-BE Studies: SOP for Management of Trial Equipment Calibration Logs – V 2.0 Standard Operating Procedure for Management of Trial Equipment Calibration Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/133/2025 Supersedes SOP/BA-BE/133/2022 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 a standardized…

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BA-BE Studies: SOP for Clinical Trial Material (CTM) Receipt Log – V 2.0 Standard Operating Procedure for Clinical Trial Material (CTM) Receipt Log in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/132/2025 Supersedes SOP/BA-BE/132/2022 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 a standardized…

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BA-BE Studies: SOP for Gowning Procedures for Clinical Staff – V 2.0 Standard Operating Procedure for Gowning Procedures for Clinical Staff in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/131/2025 Supersedes SOP/BA-BE/131/2022 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 uniform gowning procedures for…

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BA-BE Studies: SOP for Hand Hygiene and Infection Control Procedures – V 2.0 Standard Operating Procedure for Hand Hygiene and Infection Control Procedures in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/130/2025 Supersedes SOP/BA-BE/130/2022 Page No. Page 1 of 8 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedures…

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BA-BE Studies: SOP for Creating Clinical Site Master File – V 2.0 Standard Operating Procedure for Creating Clinical Site Master File in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/129/2025 Supersedes SOP/BA-BE/129/2022 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 compiling,…

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BA-BE Studies: SOP for Creating Clinical Site Close-Out Checklist – V 2.0 Standard Operating Procedure for Creating Clinical Site Close-Out Checklist in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/128/2025 Supersedes SOP/BA-BE/128/2022 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 preparing…

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BA-BE Studies: SOP for Temperature Excursion Notification and Documentation – V 2.0 Standard Operating Procedure for Temperature Excursion Notification and Documentation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/127/2025 Supersedes SOP/BA-BE/127/2022 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 a clear procedure for…

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BA-BE Studies: SOP for Ensuring Backup Power for Sample Freezers – V 2.0 Standard Operating Procedure for Ensuring Backup Power for Sample Freezers in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/126/2025 Supersedes SOP/BA-BE/126/2022 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…

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BA-BE Studies: SOP for Handling Deviations in PK Sampling Time – V 2.0 Standard Operating Procedure for Handling Deviations in PK Sampling Time in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/125/2025 Supersedes SOP/BA-BE/125/2022 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 procedure…

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