Tag: Pharmacokinetics

BA-BE Studies: SOP for Documenting Protocol Violations and CAPA – V 2.0 Standard Operating Procedure for Documenting Protocol Violations and CAPA in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/115/2025 Supersedes SOP/BA-BE/115/2022 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 uniform process for…

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BA-BE Studies: SOP for Preventing Cross-Contamination of Samples – V 2.0 Standard Operating Procedure for Preventing Cross-Contamination of Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/114/2025 Supersedes SOP/BA-BE/114/2022 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 robust and standardized procedure for…

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BA-BE Studies: SOP for Transfer of Samples from Satellite Clinics – V 2.0 Standard Operating Procedure for Transfer of Samples from Satellite Clinics in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/113/2025 Supersedes SOP/BA-BE/113/2022 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 a standardized…

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BA-BE Studies: SOP for Handling Cold Chain Breaches During Sample Storage – V 2.0 Standard Operating Procedure for Handling Cold Chain Breaches During Sample Storage in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/112/2025 Supersedes SOP/BA-BE/112/2022 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 Ensuring Compliance with Schedule Y Clinical Requirements – V 2.0 Standard Operating Procedure for Ensuring Compliance with Schedule Y Clinical Requirements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/111/2025 Supersedes SOP/BA-BE/111/2022 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…

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BA-BE Studies: SOP for Reconciliation of Clinical Sample Volumes – V 2.0 Standard Operating Procedure for Reconciliation of Clinical Sample Volumes in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/110/2025 Supersedes SOP/BA-BE/110/2022 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 systematic procedure for…

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BA-BE Studies: SOP for Clinical Trial Photography and Video Recording – V 2.0 Standard Operating Procedure for Clinical Trial Photography and Video Recording in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/109/2025 Supersedes SOP/BA-BE/109/2022 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 controlled…

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BA-BE Studies: SOP for Use of Controlled Substances in BE Studies – V 2.0 Standard Operating Procedure for Use of Controlled Substances in Bioequivalence (BE) Studies Department BA-BE Studies SOP No. SOP/BA-BE/108/2025 Supersedes SOP/BA-BE/108/2022 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…

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BA-BE Studies: SOP for Managing Subject Dropouts and Replacements in BA/BE Studies – V 2.0 Standard Operating Procedure for Managing Subject Dropouts and Replacements in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/107/2025 Supersedes SOP/BA-BE/107/2022 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…

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BA-BE Studies: SOP for Managing Female Volunteers in BA/BE Trials – V 2.0 Standard Operating Procedure for Managing Female Volunteers in BA/BE Trials Department BA-BE Studies SOP No. SOP/BA-BE/106/2025 Supersedes SOP/BA-BE/106/2022 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 the…

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