Protocol for Blood Sample Collection in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the collection, handling, and processing of pharmacokinetic (PK)…
Protocol for Oversight of BA/BE Study Sites and Monitoring Activities Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for clinical monitoring and site management activities…
Procedure for Administering Investigational Products in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the safe and accurate administration of study drugs…
Protocol for Management of Investigational Products in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling, storage, and accountability of study…
Procedure for Randomization and Masking in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the randomization and blinding processes in Bioavailability (BA)…
Procedure for Defining Study Participant Criteria Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for defining and implementing exclusion and inclusion criteria for selecting participants…
Protocol for Participant Recruitment in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the recruitment and selection of participants in Bioavailability (BA)…
Guidelines for Participant Consent in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for obtaining informed consent from participants in Bioavailability (BA) and…
Protocol for Ethical Review in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for obtaining ethical approval for Bioavailability (BA) and Bioequivalence…
Protocol for Planning BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for planning the design of Bioavailability (BA) and Bioequivalence (BE) studies…