SOPs for BA-BE Studies V 2.0

To establish a systematic and standardized approach for planning Bioavailability (BA) and Bioequivalence (BE) studies that ensures regulatory compliance, data integrity, and successful study execution aligned with global guidelines.
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To define the procedure for identifying, retrieving, and critically reviewing the reference product literature for the purpose of designing scientifically sound and regulatory-compliant bioavailability/bioequivalence (BA/BE) studies.
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To define a structured approach for drafting a scientifically sound and regulatory-compliant clinical study protocol for Bioavailability (BA) and Bioequivalence (BE) studies that ensures safety of participants, integrity of data, and successful regulatory submissions.
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To outline the procedure for selecting an appropriate study design—crossover, parallel, replicate, or alternative designs—for bioequivalence (BE) studies, ensuring the chosen approach is scientifically valid, regulatory compliant, and suited to the product’s characteristics.
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To establish a standardized process for selecting the appropriate dose strength for conducting Bioavailability and Bioequivalence (BA/BE) studies in alignment with regulatory guidance, product development goals, and safety considerations for study participants.
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To define the criteria and process for selecting fasted, fed, or both conditions in bioequivalence (BE) study designs based on pharmacokinetics, regulatory guidance, and the intended labeling of the drug product.
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To define the standard procedure for developing a study synopsis for submission to Ethics Committees or Institutional Review Boards (IRBs) during the approval process for Bioavailability/Bioequivalence (BA/BE) studies.
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To define a standard process for planning and preparing regulatory submissions for Bioequivalence (BE) studies, ensuring timely and complete documentation for national and international health authority requirements.
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To define the process of preparing, compiling, and submitting Form 44 to the Central Drugs Standard Control Organization (CDSCO), India, for obtaining approval to initiate Bioavailability/Bioequivalence (BA/BE) studies.
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To define a standardized procedure for preparing and compiling a regulatory-compliant Abbreviated New Drug Application (ANDA) dossier in eCTD format for submission to the United States Food and Drug Administration (US FDA).
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