The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference

Herein, we present the US Food and Drug Administration (FDA) Office of Research and Standards’ current thinking, challenges, and opportunities for comparative clinical endpoint bioequivalence (BE) studies of orally inhaled drug products (OIDPs). Given the product‐associated complexities of OIDPs, the FDA currently uses an aggregate weight‐of‐evidence approach to demonstrate that a generic OIDP is bioequivalent to its reference listed drug. The approach utilizes comparative clinical endpoint BE or pharmacodynamic BE studies, pharmacokinetic BE studies, and in vitro BE studies to demonstrate equivalence, in addition to formulation sameness and device similarity. For the comparative clinical endpoint BE studies, metrics based on forced expiratory volume in the first second (FEV1) are often the recommended clinical endpoints. However, the use of FEV1 can pose a challenge due to its large variability and a relatively flat dose‐response relationship for most OIDPs. The utility of applying dose‐scale analysis was also investigated by the FDA but often not recommended, due to either flat dose‐response relationships or insufficient clinical study data. As a potential way to reduce sample size, we found adapting covariate analysis only explained a limited portion of the variation based on further investigation. The FDA continues to develop alternative methods to make BE assessment of OIDPs more cost‐ and time‐efficient. Prospective generic drug applicants and academia are encouraged to participate in this effort by proposing new approaches in pre‐abbreviated new drug application meeting requests and collaborating in the form of grants and contracts under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science and Research Program.

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Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Lee

Feng

Conti

et al. 2022

Clin Pharma and Therapeutics

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Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products

Renukuntla

Palakurthi²,

Bolla³

et al. 2022

International Journal of Pharmaceutics

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An experiential program on the foundations of quantum mechanics for final-year high-school students

Montagnani¹,

Stefanel

Chiofalo

et al. 2023

Phys. Educ.

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Teaching and learning quantum mechanics is one of the most demanding educational and conceptual challenges, in particular in secondary schools where students do not possess an adequate mathematical background to effectively support the description of quantum behaviour. Educational research shows that traditional approaches, generally based on historical and narrative perspectives, are only partially effective. The reason is that they do not address in depth those basic quantum concepts that radically question the fundamentals of classical physics. A research-based educational program has been proposed to two final-year classes of an Italian scientific high school. In order to build the main concepts of quantum mechanics and their formal basic representation via real and simulated experiments, the program uses the light polarization as a context. A quantum game was then integrated in the educational program, to support students’ learning. Their conceptual paths, monitored by means of tutorials and questionnaires, show significant student learning especially on the concept of state and on appropriating the formalism meaning, whereas students more frequently referred to the geometrical vector representation instead of the algebraic-analytic formula. The quantum game has emerged to support intuition and operative experience in distinguishing the foundational concepts of superposition and entanglement.

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The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference

Cited by 4 publications

References 26 publications

Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products

An experiential program on the foundations of quantum mechanics for final-year high-school students

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