The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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) blood samples in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning,…
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 in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the oversight and monitoring…
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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 or investigational products in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the…
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 drugs or investigational products used in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved…
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) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the design, conduct, and analysis of 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 in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the development, review, and implementation…
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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…