SOPs for BA-BE Studies V 2.0

To define a standard process for identifying, selecting, verifying, and procuring the reference product (RLD – Reference Listed Drug or RMP – Reference Medicinal Product) required for conducting Bioavailability/Bioequivalence (BA/BE) studies.
Click to read the full article.

To define the procedure for managing expired reference products procured for Bioequivalence (BE) studies, including identification, segregation, documentation, and proper disposal in compliance with applicable regulatory and Good Manufacturing Practice (GMP) requirements.
Click to read the full article.

To define the process for selecting appropriate comparator drugs (Reference Listed Drugs or Reference Medicinal Products) for global regulatory submissions, ensuring scientific validity and compliance with local authority expectations.
Click to read the full article.

To establish a standard procedure for obtaining and managing clinical trial insurance coverage to safeguard the rights and well-being of study participants and to meet national and international regulatory requirements for conducting BA/BE studies.
Click to read the full article.

To establish a procedure for reviewing, interpreting, and summarizing Product-Specific Guidances (PSGs) issued by regulatory agencies such as the USFDA, EMA, and others, to guide the design and regulatory planning of Bioavailability/Bioequivalence (BA/BE) studies.
Click to read the full article.

To establish a systematic procedure for compiling, reviewing, and submitting required documentation to Ethics Committees (ECs) or Institutional Review Boards (IRBs) to obtain ethical clearance for conducting Bioavailability/Bioequivalence (BA/BE) studies.
Click to read the full article.

To define a systematic and compliant process for addressing Ethics Committee (EC) or Institutional Review Board (IRB) queries related to Bioavailability/Bioequivalence (BA/BE) studies to ensure timely resolution, protocol integrity, and ethical compliance.
Click to read the full article.

To outline the procedure for preparing and submitting Continuing Review Applications (CRA) to Institutional Ethics Committees (IEC) or Institutional Review Boards (IRB) for BA/BE studies that exceed the initial approval period or are ongoing.
Click to read the full article.

To define the procedure for initiating, reviewing, approving, and implementing protocol amendments in BA/BE clinical studies, ensuring compliance with regulatory guidelines, Good Clinical Practice (GCP), and Ethics Committee (EC) requirements.
Click to read the full article.

To define a structured procedure for initiating, planning, conducting, and documenting pre-submission meetings with regulatory authorities (e.g., CDSCO, USFDA, EMA) prior to submitting Bioavailability/Bioequivalence (BA/BE) study applications or dossiers.
Click to read the full article.