The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the recruitment and selection process, including Principal Investigators,…
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 Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the recruitment, enrollment, and consent process of study participants,…
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 (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning, conduct, and oversight of BA and BE studies,…
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 in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning, conduct, and oversight of BA and BE studies, including Principal…