Protocol for Safe Handling and Shipping of Biological Specimens in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and compliant transportation of biological samples collected during Bioavailability (BA) and Bioequivalence (BE) studies, ensuring sample integrity, stability, and regulatory compliance. Scope This SOP applies to all…
Drug absorption rate
SOP for Managing Study Supplies
Protocol for Inventory Control and Management of Study Materials in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the management of study supplies, including investigational medicinal products (IMPs), ancillary supplies, and study materials, in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This…
SOP for Change Management in Study Protocols
Protocol for Protocol Amendment and Change Control in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for managing changes to study protocols in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring consistency, compliance, and integrity throughout the study conduct. Scope This SOP applies to all study personnel involved in…
SOP for Endpoint Adjudication
Protocol for Standardizing Endpoint Assessment in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for endpoint adjudication in Bioavailability (BA) and Bioequivalence (BE) studies to ensure consistency and accuracy in the assessment of study endpoints. Scope This SOP applies to all study personnel involved in the adjudication…
SOP for Interim Analysis and Data Monitoring
Protocol for Monitoring Study Progress and Data Quality in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define procedures for conducting interim analysis and monitoring data quality during the course of Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all study personnel involved…
SOP for Insurance Coverage for Study Participants
Protocol for Ensuring Insurance Protection of Study Participants Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for providing insurance coverage to participants enrolled in Bioavailability (BA) and Bioequivalence (BE) studies, ensuring their protection against study-related injuries or adverse events. Scope This SOP applies to all study personnel involved in participant…
SOP for Pharmacovigilance
Protocol for Monitoring Drug Safety in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and reporting adverse events, serious adverse events, and other safety-related information in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all study personnel…
SOP for Safety Data Management
Protocol for Managing Safety Information in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the collection, evaluation, documentation, and reporting of safety data related to Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all study personnel involved in safety data…
SOP for Drug Return and Destruction
Protocol for Handling Returned and Expired Drugs in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for the proper handling, documentation, and disposal of returned, expired, or unused investigational drugs used in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to…
SOP for Handling Study Dropouts
Protocol for Managing Participant Withdrawals in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for handling participant dropouts and withdrawals from Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all study personnel involved in participant recruitment, enrollment, and study conduct,…