INFORMED: an incubator at the US FDA for driving innovations in data science and agile technology

Psychology, as a scientific discipline, aims to understand the mind and behavior through rigorous and systematic methods. The foundation of psychological research is evidence-based, relying heavily on the scientific method to derive and validate knowledge. This structured approach ensures that findings are reliable, valid, and applicable to broader contexts.
The scientific method in psychology involves six critical steps: making observations, formulating hypotheses, conducting tests, analyzing...

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

Mitochondrial protein import is powered by two distinct energy sources: ATP hydrolysis and electrochemical potential across the inner membrane. Newly synthesized precursors are bound by cytosolic chaperones of the Hsp70 family, which guide them to the import receptors on the mitochondrial surface. Utilizing the energy of ATP hydrolysis, Hsp70 chaperones transfer these precursors to the TOM receptors on the mitochondrial outer membrane.
Generally, polypeptides are unfolded by two distinct...

Biostatistics involves the application of statistical techniques to scientific research in health-related fields, including biology and public health. These techniques are essential for designing studies, collecting data, and analyzing it to draw meaningful conclusions. Given the complexity of biological processes, particularly in studies involving human subjects, biostatistical methods are crucial for effectively organizing and interpreting data that might otherwise obscure underlying patterns...

Checkpoints throughout the cell cycle serve as safeguards and gatekeepers, allowing the cell cycle to progress in favorable conditions and slow or halt it in problematic ones. This regulation is known as the cell cycle control system.
Cyclin-dependent kinases, or Cdks, work in concert with cyclins to control cell cycle transitions. M-Cdk, a complex of Cdk1 bound to M cyclin, is a well-known example of this coordinated control that drives the transition from the G2 to the M phase.
M cyclin...

The Statistical Package for the Social Sciences, or SPSS, is a data management and analysis software suite. Developed by SPSS Inc. in 1968 and acquired by IBM in 2009, this tool was initially designed for social science data analysis, evolving to serve a wider range of disciplines. It was later renamed to Statistical Product and Service Solutions.
SPSS streamlines the process from data preparation to analysis and reporting. It is characterized by its user-friendly interface, which conceals...