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Click ‘Get Form’ to open it in the editor.
Begin by filling out the 'Background' section, which provides essential information about the bioequivalence studies. Ensure you understand the requirements for both ANDAs and NDAs as outlined in the document.
Proceed to 'Implementation Objectives'. Here, clearly state your objectives related to verifying data quality and protecting human subjects. This section is crucial for compliance.
In 'Inspectional Operations', detail your inspection findings. Use our platform's commenting features to annotate any discrepancies or observations directly on the form.
Complete 'Attachment A' and 'Attachment B' as required. These attachments are vital for summarizing your findings and ensuring all necessary data is reported accurately.
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What is the purpose of the FDAs Bioresearch monitoring Bimo program?
The FDAs Bioresearch Monitoring (BIMO) program is aimed at safeguarding the rights, safety, and welfare of clinical trial subjects, as well as ensuring the accuracy and dependability of study data and the compliance of the study with FDA regulations.
How to check bioequivalence of a drug?
Bioequivalence is concluded if the average bioavailability of the test formulation is within 20% of that of the reference formulation with a certain assurance. This decision rule is based on the additive model and not on relative or percent change. Thus, it is not employed commonly for most drug products.
What are the key features of BIMO?
FDAs Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.
What is in vitro bioequivalence testing?
The application of in vitro bioequivalence techniques provides a realistic, science-based approach for identifying the critical material attributes associated with a drug products formulation, enabling the definition of a control strategy to manage post-approval changes.
What is bioequivalence studies in vivo?
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
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The key objectives of the BIMO Program Audit clinical data. Inspection of ongoing clinical research. Inspection of non-clinical laboratories. Inspection of Institutional Review Boards (IRB)
Related links
FDA Investigational New Drug (IND) Toolkit
Sep 3, 2020 A clinical investigation is an experiment in which a drug is administered to humans for any use that is not per the marketed use of the drug in
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