Tag: AUC (area under the curve)

BA-BE Studies: SOP for Clinical Site Monitoring Visits – V 2.0 Standard Operating Procedure for Clinical Site Monitoring Visits in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/087/2025 Supersedes SOP/BA-BE/087/2022 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 systematic process for planning, conducting,…

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BA-BE Studies: SOP for Conducting Mock Runs for BA/BE – V 2.0 Standard Operating Procedure for Conducting Mock Runs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/086/2025 Supersedes SOP/BA-BE/086/2022 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 conducting mock runs…

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BA-BE Studies: SOP for Volunteer Compensation and Reimbursement – V 2.0 Standard Operating Procedure for Volunteer Compensation and Reimbursement in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/085/2025 Supersedes SOP/BA-BE/085/2022 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 providing compensation…

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BA-BE Studies: SOP for Exit Examination of Volunteers – V 2.0 Standard Operating Procedure for Exit Examination of Volunteers in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/084/2025 Supersedes SOP/BA-BE/084/2022 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 uniform and compliant procedure for…

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BA-BE Studies: SOP for Crossover Period Washout Management – V 2.0 Standard Operating Procedure for Crossover Period Washout Management in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/083/2025 Supersedes SOP/BA-BE/083/2022 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 process for managing the washout…

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BA-BE Studies: SOP for IMP Destruction or Return Process – V 2.0 Standard Operating Procedure for IMP Destruction or Return Process in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/082/2025 Supersedes SOP/BA-BE/082/2022 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 process for…

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BA-BE Studies: SOP for IMP Accountability Logs – V 2.0 Standard Operating Procedure for IMP Accountability Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/081/2025 Supersedes SOP/BA-BE/081/2022 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 consistent and documented procedure for maintaining accurate…

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BA-BE Studies: SOP for Dispensing of Investigational Medicinal Product (IMP) – V 2.0 Standard Operating Procedure for Dispensing of Investigational Medicinal Product (IMP) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/080/2025 Supersedes SOP/BA-BE/080/2022 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 Bed Allotment and Facility Assignment – V 2.0 Standard Operating Procedure for Bed Allotment and Facility Assignment in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/079/2025 Supersedes SOP/BA-BE/079/2022 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 and unbiased…

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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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