Tag: Pharmacokinetics

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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BA-BE Studies: SOP for Maintaining Source Data Verification Logs – V 2.0 Standard Operating Procedure for Maintaining Source Data Verification Logs in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/124/2025 Supersedes SOP/BA-BE/124/2022 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 and regulatory-compliant…

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BA-BE Studies: SOP for Regulatory Inspection at Clinical Site – V 2.0 Standard Operating Procedure for Regulatory Inspection at Clinical Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/123/2025 Supersedes SOP/BA-BE/123/2022 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 and compliant…

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BA-BE Studies: SOP for Clinical Investigator’s Meeting Conduct – V 2.0 Standard Operating Procedure for Conducting Clinical Investigator’s Meeting in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/122/2025 Supersedes SOP/BA-BE/122/2022 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 for organizing and conducting…

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BA-BE Studies: SOP for Label Generation and Sample Barcode Management – V 2.0 Standard Operating Procedure for Label Generation and Sample Barcode Management in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/121/2025 Supersedes SOP/BA-BE/121/2022 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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BA-BE Studies: SOP for Document Control in Clinical Phase – V 2.0 Standard Operating Procedure for Document Control during Clinical Phase of BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/120/2025 Supersedes SOP/BA-BE/120/2022 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 systematic and compliant…

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BA-BE Studies: SOP for Securing and Tracking of Biological Waste – V 2.0 Standard Operating Procedure for Securing and Tracking of Biological Waste in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/119/2025 Supersedes SOP/BA-BE/119/2022 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…

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BA-BE Studies: SOP for Cleaning and Disinfection of Dosing Rooms – V 2.0 Standard Operating Procedure for Cleaning and Disinfection of Dosing Rooms in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/118/2025 Supersedes SOP/BA-BE/118/2022 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 standardized…

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BA-BE Studies: SOP for Environmental Monitoring in Volunteer Areas – V 2.0 Standard Operating Procedure for Environmental Monitoring in Volunteer Areas during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/117/2025 Supersedes SOP/BA-BE/117/2022 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 systematic…

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BA-BE Studies: SOP for Preventive Maintenance of Clinical Equipment – V 2.0 Standard Operating Procedure for Preventive Maintenance of Clinical Equipment in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/116/2025 Supersedes SOP/BA-BE/116/2022 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 procedure for…

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