Tag: Therapeutic equivalence

BA-BE Studies: SOP for Data Entry and Source Documentation in Clinical Phase – V 2.0 Standard Operating Procedure for Data Entry and Source Documentation in Clinical Phase of BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/091/2025 Supersedes SOP/BA-BE/091/2022 Page No. Page 1 of 10 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose…

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BA-BE Studies: SOP for Use of Case Record Forms (CRFs) in Clinical Phase – V 2.0 Standard Operating Procedure for Use of Case Record Forms (CRFs) in Clinical Phase of BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/090/2025 Supersedes SOP/BA-BE/090/2022 Page No. Page 1 of 9 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026…

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BA-BE Studies: SOP for Room Temperature Monitoring in Sample Collection Areas – V 2.0 Standard Operating Procedure for Room Temperature Monitoring in Sample Collection Areas during BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/089/2025 Supersedes SOP/BA-BE/089/2022 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 Managing Protocol Deviations During Clinical Phase – V 2.0 Standard Operating Procedure for Managing Protocol Deviations During Clinical Phase of BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/088/2025 Supersedes SOP/BA-BE/088/2022 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 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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