FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence
The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.
FDA has published a draft guidance on Dec. 5, 2022, with recommendations to sponsors and applicants who intend to use equivalence criteria in analyzing in vivo or in vitro bioequivalence (BE) studies for investigational new drug applications, new drug applications, abbreviated new drug applications, and supplements to these applications.
The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. After being finalized, it will replace the Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, which was originally issued in February 2001.
In addition to covering some of the topics in the 2001 guidance, subjects discussed in the new guidance will include missing data, intercurrent events, narrow therapeutic index drugs, variable drugs, and data preparation.
The draft guidance can be viewed in full here.
Source: FDA
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF
July 25th 2025The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety of cancers.
Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical Translation
July 16th 2025Mechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.
