By: Anton Bespalov
“The Steal syndrome – or the FDA Modernization Act to end animal testing requirement passes U.S. Senate”
November 2, 2022On September 29, 2022, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, by unanimous consent. While it is unclear…
Read More“Blinding in histopathology assessments – I see your point but…”
June 16, 2022We strongly believe that, in most cases, preclinical in vivo studies conducted without adequate protection against risks of bias (i.e., underpowered, without randomization, blinding,…
Read MoreHow much power should my next study have: One size fits all?
March 14, 2022There is a slow but steady increase in the number of publications where authors report on sample size justification. In most…
Read MorePre-study odds
March 14, 2022One of the key themes in the 2005 seminal paper by John Ioannidis “Why most published research findings are false” is…
Read MoreIllustrating the role of PPV, power and sample size with an R script
March 8, 2022This is the R Script referenced in the blog post LINK # ratio of true to not-true relationships tnott
Read MoreThe “from-quality-to-system” pendulum
December 20, 2021by Anton Bespalov and Anja Gilis In the dialectics world of the German philosopher Georg Hegel, quantitative changes transform into qualitative…
Read MoreOf peer review and data sharing
November 3, 2021We (preclinical) learn from the Big Brother (clinical). For example, they recognize the risks of bias in study design, conduct and…
Read More“Don’t cut the tree you are sitting on!”
November 3, 2021According to a recent press release from the European parliament, an EU-wide action plan is requested with ambitious and achievable objectives for phasing-out…
Read MoreAducanumab’s approval is not FDA’s failure, it is our failure
June 16, 2021On June 7, 2021, the FDA approved aducanumab, an amyloid beta-directed monoclonal antibody indicated for the treatment of Alzheimer’s disease.However, most…
Read MoreThe EQIPD Workshop “Rigor, reproducibility and data management in nonclinical research”
June 16, 2021On 21 April 2021 a virtual EQIPD workshop entitled “Rigor, reproducibility and data management in nonclinical research” was organized in Finland…
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