Tag: AUC (area under the curve)

BA-BE Studies: SOP for Clinical Trial Facility Cleaning and Hygiene – V 2.0 Standard Operating Procedure for Clinical Trial Facility Cleaning and Hygiene in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/078/2025 Supersedes SOP/BA-BE/078/2022 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 standardized cleaning…

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BA-BE Studies: SOP for Chain of Custody for Clinical Samples – V 2.0 Standard Operating Procedure for Chain of Custody for Clinical Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/077/2025 Supersedes SOP/BA-BE/077/2022 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 standardized…

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BA-BE Studies: SOP for Monitoring Ambient Conditions of Sample Freezers – V 2.0 Standard Operating Procedure for Monitoring Ambient Conditions of Sample Freezers in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/076/2025 Supersedes SOP/BA-BE/076/2022 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 consistent…

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BA-BE Studies: SOP for Sample Storage at -20°C and -70°C – V 2.0 Standard Operating Procedure for Sample Storage at -20°C and -70°C in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/075/2025 Supersedes SOP/BA-BE/075/2022 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 Plasma Separation and Aliquoting – V 2.0 Standard Operating Procedure for Plasma Separation and Aliquoting in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/074/2025 Supersedes SOP/BA-BE/074/2022 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 for separation of plasma…

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BA-BE Studies: SOP for Labelling of Biological Samples – V 2.0 Standard Operating Procedure for Labelling of Biological Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/073/2025 Supersedes SOP/BA-BE/073/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To provide a standardized procedure for labelling biological…

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BA-BE Studies: SOP for Processing and Centrifugation of Blood Samples – V 2.0 Standard Operating Procedure for Processing and Centrifugation of Blood Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/072/2025 Supersedes SOP/BA-BE/072/2022 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…

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BA-BE Studies: SOP for Blood Sample Collection Schedule Adherence – V 2.0 Standard Operating Procedure for Blood Sample Collection Schedule Adherence in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/071/2025 Supersedes SOP/BA-BE/071/2022 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 process for…

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BA-BE Studies: SOP for Re-Dosing in Cross-Over Study Designs – V 2.0 Standard Operating Procedure for Re-Dosing in Cross-Over Study Designs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/070/2025 Supersedes SOP/BA-BE/070/2022 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 clear and compliant…

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BA-BE Studies: SOP for Clinical Documentation of Adverse Events – V 2.0 Standard Operating Procedure for Clinical Documentation of Adverse Events in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/069/2025 Supersedes SOP/BA-BE/069/2022 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 standardized procedure for…

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