The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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 the quantitative analysis of drug compounds and metabolites in biological samples collected from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the…
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 plasma samples collected from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scope This SOP applies to all personnel…
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 samples from study participants in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry. Scgogpe This SOP applies to all personnel involved in…
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,…