Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products
Sara Carolina Henriques, Ana Leblanc, Sérgio Simões, Marlene Fonseca, Francisco Luís Pimentel, Luis Almeida, Nuno Elvas Silva, Im-Sook Song · 2024
Read Unveiling the Potential of Cmax f2 Factor Applied to Pilot Bioavailability/Bioequivalence Studies—A Case Study with Pazopanib Drug Products by Sara Carolina Henriques, Ana Leblanc, Sérgio Simões, Marlene Fonseca, Francisco Luís Pimentel, Luis Almeida, Nuno Elvas Silva, Im-Sook Song (2024) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/pmc-11678822.txt.
Description
Sara Carolina Henriques and co-authors test a simpler way to judge small pilot drug studies, in this 2024 paper. Before a full trial, drug makers run small studies to check whether a new copy of a drug matches the original in the body. Small samples make the usual statistics shaky, mainly for the peak drug level in the blood.
The team applied a similarity factor, called f2, to pilot data for the cancer drug pazopanib in two strengths. Despite wide variation between subjects, the factor correctly predicted the outcomes of the later full trials. The authors propose it as a steadier gatekeeper for go or no-go choices.
Catalog record
| CREATOR | Sara Carolina Henriques, Ana Leblanc, Sérgio Simões, Marlene Fonseca, Francisco Luís Pimentel, Luis Almeida, Nuno Elvas Silva, Im-Sook Song |
|---|---|
| YEAR | 2024 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 39 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |