Tag: Bioavailability

BA-BE Studies: SOP for Use of LC-MS/MS in BA/BE Studies – V 2.0 Standard Operating Procedure for Use of LC-MS/MS in Bioavailability and Bioequivalence Studies Department BA-BE Studies SOP No. SOP/BA-BE/160/2025 Supersedes SOP/BA-BE/160/2022 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 procedure…

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BA-BE Studies: SOP for Protein Precipitation Method in Plasma – V 2.0 Standard Operating Procedure for Protein Precipitation Method in Plasma for BA/BE Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/159/2025 Supersedes SOP/BA-BE/159/2022 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 procedure…

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BA-BE Studies: SOP for Liquid-Liquid Extraction (LLE) Technique – V 2.0 Standard Operating Procedure for Liquid-Liquid Extraction (LLE) Technique in BA/BE Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/158/2025 Supersedes SOP/BA-BE/158/2022 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 liquid-liquid…

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BA-BE Studies: SOP for Solid Phase Extraction (SPE) Method – V 2.0 Standard Operating Procedure for Solid Phase Extraction (SPE) Method in BA/BE Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/157/2025 Supersedes SOP/BA-BE/157/2022 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 for…

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BA-BE Studies: SOP for Sample Extraction Procedure for Plasma Samples – V 2.0 Standard Operating Procedure for Sample Extraction from Plasma in BA/BE Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/156/2025 Supersedes SOP/BA-BE/156/2022 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 detailed procedure…

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BA-BE Studies: SOP for Sample Thawing and Equilibration – V 2.0 Standard Operating Procedure for Sample Thawing and Equilibration in Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/155/2025 Supersedes SOP/BA-BE/155/2022 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 controlled procedure for thawing and…

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BA-BE Studies: SOP for Preparation and Use of Quality Control Samples – V 2.0 Standard Operating Procedure for Preparation and Use of Quality Control Samples in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/154/2025 Supersedes SOP/BA-BE/154/2022 Page No. Page 1 of 11 Issue Date 17/04/2025 Effective Date 20/04/2025 Review Date 17/04/2026 1. Purpose To define…

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BA-BE Studies: SOP for Preparation and Use of Calibration Standards – V 2.0 Standard Operating Procedure for Preparation and Use of Calibration Standards in Bioanalytical Studies Department BA-BE Studies SOP No. SOP/BA-BE/153/2025 Supersedes SOP/BA-BE/153/2022 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 Bioanalytical Method Validation as per ICH M10 – V 2.0 Standard Operating Procedure for Bioanalytical Method Validation Based on ICH M10 Guidelines Department BA-BE Studies SOP No. SOP/BA-BE/152/2025 Supersedes SOP/BA-BE/152/2022 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 detailed…

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BA-BE Studies: SOP for Bioanalytical Method Development – V 2.0 Standard Operating Procedure for Bioanalytical Method Development in BA/BE Studies Department BA-BE Studies SOP No. SOP/BA-BE/151/2025 Supersedes SOP/BA-BE/151/2022 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 structured and compliant process for the development…

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