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I would like to see more examination of the validation requirement beyond the lens of peer review, and I would like a deeper examination of incentives and credit beyond citation.
For in vitro DNT methods, validation requirement (Hartung et al. 2004) may be relaxed when the goal of testing is screening of chemical library to identify substances of highest concern for further testing.
This focus does not ignore the validation requirement for a new clinical composite outcome, but merely emphasizes responsiveness as the area of greatest challenge with a very slowly declining population.
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The validation requirements of pharmaceutical plants require pump manufacturers to have a good understanding of plant processes.
During pre-validation method development, we systematically examined every aspect of the method, and made significant modifications when required to fulfill advanced validation requirements.
The validation requirements are much higher for surrogate endpoints than for pharmacodynamic biomarkers.
However, we could not find any published equilibrium sampling methods able to fulfil these validation requirements.
The chapter concludes with a discussion of concept validation, requirements validation, and the details of the verification process.
Consequently, the validation requirements of analytical procedures become more complex and comprehensive, and a suitable strategy is described.
In addition it significantly reduces process liquid waste, labour costs and on-site quality and validation requirements.
Called the Council on Integrity in Results Reporting (damn y'all that is… really quite an acronym), the organization will create truth in advertising standards, and common definitions, documentation and validation requirements for all participating organizations.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.
Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com