SOPs for BA-BE Studies V 2.0

To establish a standardized process for ensuring accurate adherence to the blood sample collection schedule in Bioavailability/Bioequivalence (BA/BE) studies as per protocol-defined time points, maintaining sample integrity and study validity.
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To establish a standardized method for the timely and consistent processing and centrifugation of blood samples collected during Bioavailability/Bioequivalence (BA/BE) studies to ensure plasma integrity and analytical reliability.
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To provide a standardized procedure for labelling biological samples, including blood and plasma, collected during Bioavailability/Bioequivalence (BA/BE) studies to ensure traceability, prevent mix-ups, and support regulatory compliance.
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To define the procedure for separation of plasma from whole blood and its subsequent aliquoting into labelled containers for storage and bioanalysis during Bioavailability/Bioequivalence (BA/BE) studies.
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To define a standardized procedure for the proper storage of biological samples, including plasma, serum, and whole blood, at -20°C and -70°C in Bioavailability/Bioequivalence (BA/BE) studies, ensuring stability and traceability of samples until analysis.
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To establish a consistent and reliable procedure for monitoring the ambient temperature and relative humidity conditions of rooms where -20°C and -70°C sample freezers are installed, thereby ensuring optimal operating conditions and sample integrity in BA/BE studies.
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To define a standardized process for maintaining an uninterrupted and verifiable chain of custody for biological samples collected during Bioavailability/Bioequivalence (BA/BE) studies from the point of collection to final analysis or disposal.
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To establish standardized cleaning and hygiene practices for clinical trial facilities conducting Bioavailability/Bioequivalence (BA/BE) studies to ensure subject safety, regulatory compliance, and data integrity.
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To define a standardized and unbiased process for bed allotment and facility assignment for healthy volunteers enrolled in Bioavailability/Bioequivalence (BA/BE) studies, ensuring regulatory compliance, safety, and operational efficiency.
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To define a standardized procedure for the secure dispensing of the Investigational Medicinal Product (IMP) during Bioavailability/Bioequivalence (BA/BE) studies, ensuring traceability, subject safety, and regulatory compliance.
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