Tag: FDA bioequivalence guidelines

BA-BE Studies: SOP for Responding to Ethics Committee Queries – V 2.0 Standard Operating Procedure for Responding to Ethics Committee Queries in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/017/2025 Supersedes SOP/BA-BE/017/2022 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 systematic and compliant…

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BA-BE Studies: SOP for Ethics Committee Submission Requirements – V 2.0 Standard Operating Procedure for Ethics Committee Submission Requirements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/016/2025 Supersedes SOP/BA-BE/016/2022 Page No. Page 1 of 13 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To establish a systematic procedure for compiling, reviewing,…

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BA-BE Studies: SOP for Preparing Product-Specific Guidance Review Summary – V 2.0 Standard Operating Procedure for Preparing Product-Specific Guidance Review Summary in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/015/2025 Supersedes SOP/BA-BE/015/2022 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 reviewing,…

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BA-BE Studies: SOP for Clinical Trial Insurance for BA/BE Studies – V 2.0 Standard Operating Procedure for Clinical Trial Insurance for BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/014/2025 Supersedes SOP/BA-BE/014/2022 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 standard procedure for obtaining…

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BA-BE Studies: SOP for Selection of Comparator Drugs for Global Submissions – V 2.0 Standard Operating Procedure for Selection of Comparator Drugs for Global Submissions in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/013/2025 Supersedes SOP/BA-BE/013/2022 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…

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BA-BE Studies: SOP for Handling Expired Reference Products – V 2.0 Standard Operating Procedure for Handling Expired Reference Products in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/012/2025 Supersedes SOP/BA-BE/012/2022 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 managing expired reference…

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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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