Tag: Cmax (maximum concentration)

BA-BE Studies: SOP for Emergency Exit and Fire Drill Plan at Clinical Site – V 2.0 Standard Operating Procedure for Emergency Exit and Fire Drill Plan at Clinical Site in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/103/2025 Supersedes SOP/BA-BE/103/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026…

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BA-BE Studies: SOP for Contingency Plan for Power or Equipment Failure – V 2.0 Standard Operating Procedure for Contingency Plan for Power or Equipment Failure in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/102/2025 Supersedes SOP/BA-BE/102/2022 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…

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BA-BE Studies: SOP for Training of Clinical Staff on Protocol Amendments – V 2.0 Standard Operating Procedure for Training of Clinical Staff on Protocol Amendments in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/101/2025 Supersedes SOP/BA-BE/101/2022 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…

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BA-BE Studies: SOP for Clinical Phase Audit Preparation – V 2.0 Standard Operating Procedure for Clinical Phase Audit Preparation in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/100/2025 Supersedes SOP/BA-BE/100/2022 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 process for preparing the clinical…

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BA-BE Studies: SOP for Interim Clinical Monitoring Reports – V 2.0 Standard Operating Procedure for Interim Clinical Monitoring Reports in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/099/2025 Supersedes SOP/BA-BE/099/2022 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, reviewing, and…

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BA-BE Studies: SOP for Maintaining Blinding in Blinded Studies – V 2.0 Standard Operating Procedure for Maintaining Blinding in Blinded Studies Department BA-BE Studies SOP No. SOP/BA-BE/098/2025 Supersedes SOP/BA-BE/098/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for maintaining the integrity of…

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BA-BE Studies: SOP for Monitoring Compliance of Subject Activities – V 2.0 Standard Operating Procedure for Monitoring Compliance of Subject Activities in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/097/2025 Supersedes SOP/BA-BE/097/2022 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 procedure for…

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BA-BE Studies: SOP for Handling of Vomiting or Spitting Cases Post-Dose – V 2.0 Standard Operating Procedure for Handling of Vomiting or Spitting Cases Post-Dose in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/096/2025 Supersedes SOP/BA-BE/096/2022 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…

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BA-BE Studies: SOP for Documenting Concomitant Medication Usage – V 2.0 Standard Operating Procedure for Documenting Concomitant Medication Usage in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/095/2025 Supersedes SOP/BA-BE/095/2022 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 documenting concomitant…

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BA-BE Studies: SOP for Transport of Plasma Samples to Bioanalytical Lab – V 2.0 Standard Operating Procedure for Transport of Plasma Samples to Bioanalytical Lab Department BA-BE Studies SOP No. SOP/BA-BE/094/2025 Supersedes SOP/BA-BE/094/2022 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…

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