Tag: Tmax (time to maximum concentration)

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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BA-BE Studies: SOP for Handling Serious Adverse Events (SAEs) – V 2.0 Standard Operating Procedure for Handling Serious Adverse Events (SAEs) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/068/2025 Supersedes SOP/BA-BE/068/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To provide a clear, standardized procedure…

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BA-BE Studies: SOP for First-Aid Management of Mild Reactions – V 2.0 Standard Operating Procedure for First-Aid Management of Mild Reactions in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/067/2025 Supersedes SOP/BA-BE/067/2022 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 clear and systematic…

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BA-BE Studies: SOP for Periodic Clinical Safety Assessments – V 2.0 Standard Operating Procedure for Periodic Clinical Safety Assessments in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/066/2025 Supersedes SOP/BA-BE/066/2022 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 standard operating procedure for conducting…

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BA-BE Studies: SOP for Monitoring Vital Signs During Clinical Phase – V 2.0 Standard Operating Procedure for Monitoring Vital Signs During Clinical Phase in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/065/2025 Supersedes SOP/BA-BE/065/2022 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 standard…

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BA-BE Studies: SOP for Observing Post-Dose Adverse Events – V 2.0 Standard Operating Procedure for Observing Post-Dose Adverse Events in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/064/2025 Supersedes SOP/BA-BE/064/2022 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 approach for monitoring, identifying,…

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BA-BE Studies: SOP for Supervision of Dosing Procedures – V 2.0 Standard Operating Procedure for Supervision of Dosing Procedures in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/063/2025 Supersedes SOP/BA-BE/063/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To describe the procedure for the supervision of…

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BA-BE Studies: SOP for Water Intake Restrictions and Management – V 2.0 Standard Operating Procedure for Water Intake Restrictions and Management in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/062/2025 Supersedes SOP/BA-BE/062/2022 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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BA-BE Studies: SOP for Meal Composition and Timing for Fed Studies – V 2.0 Standard Operating Procedure for Meal Composition and Timing for Fed Studies in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/061/2025 Supersedes SOP/BA-BE/061/2022 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…

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