Tag: Bioequivalence criteria

BA-BE Studies: SOP for Review of Subject Recruitment Feasibility – V 2.0 Standard Operating Procedure for Review of Subject Recruitment Feasibility in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/037/2025 Supersedes SOP/BA-BE/037/2022 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 reviewing…

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BA-BE Studies: SOP for Training of Study Staff on Protocol and GCP – V 2.0 Standard Operating Procedure for Training of Study Staff on Protocol and GCP in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/036/2025 Supersedes SOP/BA-BE/036/2022 Page No. Page 1 of 13 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 Handling Confidentiality Agreements with Study Sites – V 2.0 Standard Operating Procedure for Handling Confidentiality Agreements with Study Sites in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/035/2025 Supersedes SOP/BA-BE/035/2022 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…

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BA-BE Studies: SOP for Pre-Study Kickoff Meeting Conduct – V 2.0 Standard Operating Procedure for Pre-Study Kickoff Meeting Conduct in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/034/2025 Supersedes SOP/BA-BE/034/2022 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 conducting a pre-study…

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BA-BE Studies: SOP for Review of SmPC for EU BA/BE Submissions – V 2.0 Standard Operating Procedure for Review of SmPC for EU BA/BE Submissions Department BA-BE Studies SOP No. SOP/BA-BE/033/2025 Supersedes SOP/BA-BE/033/2022 Page No. Page 1 of 12 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a procedure for…

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BA-BE Studies: SOP for Review of Product Monograph and Prescribing Information – V 2.0 Standard Operating Procedure for Review of Product Monograph and Prescribing Information in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/032/2025 Supersedes SOP/BA-BE/032/2022 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…

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BA-BE Studies: SOP for Study Initiation Checklist – V 2.0 Standard Operating Procedure for Study Initiation Checklist in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/031/2025 Supersedes SOP/BA-BE/031/2022 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 a standardized procedure for the creation and use…

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BA-BE Studies: SOP for Preparing Clinical Investigator’s Brochure (CIB) – V 2.0 Standard Operating Procedure for Preparing Clinical Investigator’s Brochure (CIB) in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/030/2025 Supersedes SOP/BA-BE/030/2022 Page No. Page 1 of 13 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 Risk Assessment of Study Protocol in BA/BE Studies – V 2.0 Standard Operating Procedure for Risk Assessment of Study Protocol in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/029/2025 Supersedes SOP/BA-BE/029/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the…

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BA-BE Studies: SOP for Blinding and Unblinding Protocols in BA/BE Studies – V 2.0 Standard Operating Procedure for Blinding and Unblinding Protocols in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/028/2025 Supersedes SOP/BA-BE/028/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define the standard procedure…

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