抗体-药物结合体表征和质量控制中的多属性方法:机遇,挑战和监管前景

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...

Behavior is a product of both the situation (e.g., cultural influences, social roles, and the presence of bystanders) and of the person (e.g., personality characteristics). Subfields of psychology tend to focus on one influence or behavior over others. Situationism is the view that our behavior and actions are determined by our immediate environment and surroundings. In contrast, dispositionism holds that our behavior is determined by internal factors (Heider, 1958).

According to some social psychologists, people tend to overemphasize internal factors as explanations—or attributions—for the behavior of other people. They tend to assume that the behavior of another person is a trait of that person, and to underestimate the power of the situation on the behavior of others. They tend to fail to recognize when the behavior of another is due to situational variables, and thus to the person’s state. This erroneous assumption is...

Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...

In social interactions, individuals frequently seek to understand the motivations and causes behind others' behaviors. This fundamental aspect of social perception, known as attribution, plays a crucial role in shaping interpersonal relationships and guiding future actions. Attribution refers to the cognitive process through which people infer the reasons behind others' behaviors, allowing them to assess character traits, intentions, and situational influences.Attribution Theory and Its...