Tag: Tmax (time to maximum concentration)

BA-BE Studies: SOP for Regulatory Submission Planning for BE Studies – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Developing Study Synopsis for Ethics Submission – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Fasted vs Fed Study Design Selection – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Dose Selection Criteria for BA/BE Studies – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Selecting Bioequivalence Study Design (Crossover, Parallel, etc.) – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Designing Clinical Study Protocol for BA/BE – V 2.0

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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 V 2.0

BA-BE Studies: SOP for Reviewing Reference Product Literature – V 2.0

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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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BA-BE Studies V 2.0

BA-BE Studies: SOP for Planning of BA/BE Studies – V 2.0

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BA-BE Studies: SOP for Planning of BA/BE Studies – V 2.0 Standard Operating Procedure for Planning of BA/BE Studies in Pharmaceutical Development Department BA-BE Studies SOP No. SOP/BA-BE/001/2025 Supersedes SOP/BA-BE/001/2022 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 and standardized approach for…

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BA-BE Studies V 2.0

SOP for Post-study Follow-up

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Protocol for Participant Monitoring after BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for conducting post-study follow-up activities with participants who have completed Bioavailability (BA) and Bioequivalence (BE) studies, ensuring their ongoing well-being, providing necessary support, and facilitating long-term data collection. Scope This SOP applies to all study…

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Bioequivalence Bioavailability Study

SOP for Study Termination Procedures

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Protocol for Ending BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the termination of Bioavailability (BA) and Bioequivalence (BE) studies, ensuring proper closure of study activities, data collection, and documentation in accordance with regulatory requirements and study protocols. Scope This SOP applies to all study personnel involved…

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Bioequivalence Bioavailability Study