Tag: Randomized controlled trial

BA-BE Studies: SOP for Administration of Study Drug in Fasted State – V 2.0 Standard Operating Procedure for Administration of Study Drug in Fasted State in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/060/2025 Supersedes SOP/BA-BE/060/2022 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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BA-BE Studies: SOP for Administration of Study Drug in Fed State – V 2.0 Standard Operating Procedure for Administration of Study Drug in Fed State in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/059/2025 Supersedes SOP/BA-BE/059/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish…

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BA-BE Studies: SOP for Scheduling of Pre-Dose Fasting Period – V 2.0 Standard Operating Procedure for Scheduling of Pre-Dose Fasting Period in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/058/2025 Supersedes SOP/BA-BE/058/2022 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 procedure for…

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BA-BE Studies: SOP for Laboratory Safety Tests Prior to Dosing – V 2.0 Standard Operating Procedure for Laboratory Safety Tests Prior to Dosing in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/057/2025 Supersedes SOP/BA-BE/057/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure…

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BA-BE Studies: SOP for ECG Monitoring Before Dosing – V 2.0 Standard Operating Procedure for ECG Monitoring Before Dosing in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/056/2025 Supersedes SOP/BA-BE/056/2022 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 and documenting…

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BA-BE Studies: SOP for Physical Examination Prior to Dosing – V 2.0 Standard Operating Procedure for Physical Examination Prior to Dosing in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/055/2025 Supersedes SOP/BA-BE/055/2022 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…

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BA-BE Studies: SOP for Informed Consent Process Execution – V 2.0 Standard Operating Procedure for Informed Consent Process Execution in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/054/2025 Supersedes SOP/BA-BE/054/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for obtaining and documenting…

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BA-BE Studies: SOP for Medical History Documentation in Healthy Volunteers – V 2.0 Standard Operating Procedure for Medical History Documentation in Healthy Volunteers for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/053/2025 Supersedes SOP/BA-BE/053/2022 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 Subject Enrolment and Randomization Process – V 2.0 Standard Operating Procedure for Subject Enrolment and Randomization Process in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/052/2025 Supersedes SOP/BA-BE/052/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for enrolling…

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BA-BE Studies: SOP for Volunteer Screening and Selection Criteria – V 2.0 Standard Operating Procedure for Volunteer Screening and Selection Criteria in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/051/2025 Supersedes SOP/BA-BE/051/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the procedure for screening…

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