Unveiling the Potential of C<sub>max</sub> <i>f</i><sub>2</sub> Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products

Unveiling the Potential of C<sub>max</sub> <i>f</i><sub>2</sub> Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products

<b>Background:</b> When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to move forward or not with a full-size pivo...

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Main Authors: Sara Carolina Henriques, Ana Leblanc, Sérgio Simões, Marlene Fonseca, Francisco Luís Pimentel, Luis Almeida, Nuno Elvas Silva
Format: Article
Language:English
Published: MDPI AG 2024-12-01
Series:Pharmaceutics
Subjects:
bioequivalence
generic medicinal products
pilot studies
<i>f</i><sub>2</sub> factor
pharmacokinetics
highly variable drugs
Online Access:https://www.mdpi.com/1999-4923/16/12/1579
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Summary:<b>Background:</b> When companies are uncertain about the potential of a new formulation to be bioequivalent to a Reference product, it is common practice to carry out downsized pilot studies as a gatekeeping in vivo strategy to decide whether to move forward or not with a full-size pivotal study. However, due to the small study size, these studies are inarguably more sensitive to variability. <b>Objectives:</b> To address and mitigate the uncertainty of the conclusions of pilot studies concerning the maximum observed concentration (C<sub>max</sub>), the <i>f</i><sub>2</sub> factor was proposed as an alternative approach to the average bioequivalence statistical methodology. <b>Methods:</b> In this work, the alternative methodology is applied to pharmacokinetic data from pilot bioequivalence trials performed with pazopanib 200 mg and 400 mg. <b>Results:</b> Despite the small sample size, and very high intra-subject variability, the <i>f</i><sub>2</sub> factor demonstrated the potential for predicting bioequivalence. The positive results were confirmed in the full sized pivotal studies. <b>Conclusions:</b> In conclusion, this alternate methodology shows promise in reducing uncertainty associated with pilot studies and aiding in decisions to go forward with pivotal bioequivalence studies.
ISSN:1999-4923

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