Read more about the article Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies
Ensuring Data Integrity: FDA's Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

Ensuring Data Integrity: FDA’s Draft Guidance on In Vivo Bioavailability and Bioequivalence Studies

The FDA recently unveiled the draft guidance for the industry titled, “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” This draft guidance serves as a framework for maintaining the highest standards of data integrity in clinical and bioanalytical domains, crucial for supporting investigational new drug applications, new drug applications, and abbreviated new drug applications.

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