Protocol for Surveillance and Documentation of Adverse Events in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic monitoring, documentation, assessment,…
Protocol for Management of Protocol Violations in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the identification, documentation, evaluation, and management of…
Protocol for PK and Statistical Analysis in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the pharmacokinetic (PK) and statistical analysis of…
Protocol for Data Input and Handling in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the accurate, timely, and secure entry and…
Protocol for Data Capture and Record-keeping in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the systematic collection, recording, and management of…
Protocol for Setting up and Conducting Analytical Runs in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the setup, execution, and documentation…
Protocol for Calibration and Maintenance of Laboratory Instruments Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the calibration, verification, and maintenance of analytical equipment…
Protocol for Validation of Bioanalytical Methods in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the validation of bioanalytical methods used for…
Protocol for Plasma Handling and Processing in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling, processing, and storage of…
Protocol for Venous Blood Collection in BA/BE Studies Pugrpose The purpgose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and standardized collection of venous blood…