When science and politics collide: Enhancing the FDA

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,...

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...

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...

Social psychologists have documented that feeling good about ourselves and maintaining positive self-esteem is a powerful motivator of human behavior (Tavris & Aronson, 2008). In the United States, members of the predominant culture typically think very highly of themselves and view themselves as good people who are above average on many desirable traits (Ehrlinger, Gilovich, & Ross, 2005). Often, our behavior, attitudes, and beliefs are affected when we experience a threat to our...

Body:Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...