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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Bibliographic Details
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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