Tag: Therapeutic equivalence

BA-BE Studies: SOP for Reference Product Selection and Procurement – V 2.0 Standard Operating Procedure for Reference Product Selection and Procurement in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/011/2025 Supersedes SOP/BA-BE/011/2022 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 standard process for…

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BA-BE Studies: SOP for Preparation of Dossiers for US FDA ANDA Submissions – V 2.0 Standard Operating Procedure for Preparation of Dossiers for US FDA ANDA Submissions Department BA-BE Studies SOP No. SOP/BA-BE/010/2025 Supersedes SOP/BA-BE/010/2022 Page No. Page 1 of 14 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a…

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BA-BE Studies: SOP for Filing Form 44 to CDSCO for BA/BE Studies – V 2.0 Standard Operating Procedure for Filing Form 44 to CDSCO for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/009/2025 Supersedes SOP/BA-BE/009/2022 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 Regulatory Submission Planning for BE Studies – V 2.0 Standard Operating Procedure for Regulatory Submission Planning for Bioequivalence Studies Department BA-BE Studies SOP No. SOP/BA-BE/008/2025 Supersedes SOP/BA-BE/008/2022 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 standard process for planning…

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BA-BE Studies: SOP for Developing Study Synopsis for Ethics Submission – V 2.0 Standard Operating Procedure for Developing Study Synopsis for Ethics Submission in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/007/2025 Supersedes SOP/BA-BE/007/2022 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 standard…

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BA-BE Studies: SOP for Fasted vs Fed Study Design Selection – V 2.0 Standard Operating Procedure for Fasted vs Fed Study Design Selection in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/006/2025 Supersedes SOP/BA-BE/006/2022 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 criteria…

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BA-BE Studies: SOP for Dose Selection Criteria for BA/BE Studies – V 2.0 Standard Operating Procedure for Dose Selection Criteria in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/005/2025 Supersedes SOP/BA-BE/005/2022 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 standardized process for selecting…

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BA-BE Studies: SOP for Selecting Bioequivalence Study Design (Crossover, Parallel, etc.) – V 2.0 Standard Operating Procedure for Selecting Bioequivalence Study Design in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/004/2025 Supersedes SOP/BA-BE/004/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To outline the procedure for…

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BA-BE Studies: SOP for Designing Clinical Study Protocol for BA/BE – V 2.0 Standard Operating Procedure for Designing Clinical Study Protocol for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/003/2025 Supersedes SOP/BA-BE/003/2022 Page No. Page 1 of 14 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define a structured approach for…

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BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0 Standard Operating Procedure for Reviewing Reference Product Literature in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/002/2025 Supersedes SOP/BA-BE/002/2022 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 identifying, retrieving, and…

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