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…
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…
Protocol for Unmasking Treatment Allocation in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling of unblinding procedures in Bioavailability (BA)…
Protocol for Ensuring Environmental Health and Safety in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for maintaining environmental health and safety standards…
Protocol for Assessing Stability of Investigational Compounds in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the stability testing of study compounds…
Protocol for Reassessment of Analytical Results in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the reanalysis of samples in Bioavailability (BA)…
Protocol for Verification of Bioanalytical Method Performance in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the cross-validation of bioanalytical methods used…
Protocol for Management of External Laboratory Data in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling and integration of external…
Protocol for Electronic Data Management in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the use of software and electronic data capture…
Protocol for Ensuring Confidentiality and Data Security in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for managing confidentiality and data protection in…