What question did this study set out to answer?

To evaluate the current state of knowledge, identify information gaps, and examine whether pharmacokinetics can serve as the primary determinant of in vivo bioequivalence for locally acting orally inhaled drug products.

March 31, 2011Journal of Aerosol Medicine and Pulmonary Drug Delivery

Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report

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Authors

DODennis O’ConnorBoehringer Ingelheim (Germany)WAWallace P. AdamsCenter for Drug Evaluation and Research MCMei‐Ling ChenNanjing Forestry University

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Implication

Expert workshop report evaluates pharmacokinetic approaches for bioequivalence in orally inhaled products, suggesting simplified regulatory pathways.

Key Points

To evaluate the current state of knowledge, identify information gaps, and examine whether pharmacokinetics can serve as the primary determinant of in vivo bioequivalence for locally acting orally inhaled drug products.
Convened an expert workshop sponsored by PQRI and RDD in April 2010 bringing together regulatory and scientific specialists.
Evaluated the relationship between pharmacokinetics, in vitro testing, pharmacodynamic studies, and lung deposition patterns.
Assessed existing regulatory precedents, notably the European approach of utilizing pharmacokinetic data alone for in vivo bioequivalence.
Sensitivity to detect product performance variations decreases moving from in vitro testing to pharmacodynamic measurements, where establishing clear dose-response relationships remains a major hurdle.
Demonstrating bioequivalence solely through pharmacodynamic endpoints in inhaled corticosteroids is limited by insufficient assay sensitivity.
Broad expert and regulatory consensus supports further exploring pharmacokinetic data alone or with in vitro tests to establish bioequivalence in certain orally inhaled products.

Cite This Study

O’Connor et al. (2011) studied this question.

synapsesocial.com/papers/69d736fdc74376700bf30b10 https://doi.org/10.1089/jamp.2011.0878

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Implication

Expert workshop report evaluates pharmacokinetic approaches for bioequivalence in orally inhaled products, suggesting simplified regulatory pathways.

Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report

Discussion

Member takes

Implication

Key Points

Cite This Study

Role of Pharmacokinetics in Establishing Bioequivalence for Orally Inhaled Drug Products: Workshop Summary Report

Discussion

Member takes

Implication

Key Points

Cite This Study

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