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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Drugs, encompassing various chemical compounds from natural sources, lab synthesis, or genetic engineering, elicit different biological responses in living organisms. Some of these responses are desirable or therapeutic, while others are undesirable. The primary goal of administering a drug is to achieve a therapeutic effect, that is, to address a specific disease or health condition. Any concurrent effects outside of this therapeutic outcome are considered undesirable. These undesirable...
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Information is everywhere and its presentation—such as how and when items are presented—can impact our perceptions and decisions surrounding the info. This broad concept umbrellas framing effects—influences that occur due to the way information is framed in its appearance, whether it’s purely the order or the specific wording of a message. Let’s take a look at numerous ways in which two versions of something can objectively say the same thing, yet we respond in...
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Bias01:22

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Bias refers to any tendency that prevents a question from being considered unprejudiced. In research, bias occurs when one outcome or answer is selected or encouraged over others in sampling or testing. Bias can occur during any research phase, including study design, data collection, analysis, and publication.
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Biases can arise at various stages of research, from study design and data collection to analysis and interpretation. Recognizing and addressing these biases is essential to ensure the validity and reliability of epidemiological findings.Broadly speaking, biases in epidemiology fall into three main categories: selection bias, information bias, and confounding. A more detailed description of possible biases is:  
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Confounding in statistical epidemiology represents a pivotal challenge, referring to the distortion in the perceived relationship between an exposure and an outcome due to the presence of a third variable, known as a confounder. This variable is associated with both the exposure and the outcome but is not a direct link in their causal chain. Its presence can lead to erroneous interpretations of the exposure's effect, either exaggerating or underestimating the true association. This...
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Updated: Jan 18, 2026

Comparing Eye-tracking Data of Children with High-functioning ASD, Comorbid ADHD, and of a Control Watching Social Videos
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Is It Adverse, Nonadverse, Adaptive, or Artifact?

Arun R Pandiri1, Roy L Kerlin2, Peter C Mann3

  • 11 National Toxicology Program, Research Triangle Park, North Carolina, USA.

Toxicologic Pathology
|October 23, 2016
PubMed
Summary
This summary is machine-generated.

Toxicologic pathologists face challenges differentiating adverse effects from nonadverse responses. This continuing education course summarized guidance on determining and communicating adversity in nonclinical toxicology studies.

Keywords:
adaptive responseadversityartifactnonadverse response

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Area of Science:

  • Toxicologic Pathology
  • Preclinical Study Interpretation

Background:

  • Differentiating true adverse effects from nonadverse or adaptive responses is a key challenge for toxicologic pathologists.
  • Recent guidance from the Society of Toxicologic Pathology (STP) and European STP aids in determining and communicating adversity in nonclinical studies.

Purpose of the Study:

  • To provide a forum for discussion on determining and communicating adversity in toxicology.
  • To summarize key lectures from a continuing education course held at the 2016 STP Annual Meeting.

Main Methods:

  • Summaries of lectures presented at a continuing education course.
  • Case studies in clinical and anatomic pathology were used to illustrate adversity determination.
  • Discussions included data quality, study design, artifact interpretation, and regulatory engagement.

Main Results:

  • Guidance on determining and communicating adversity was presented.
  • The role of data quality and study design in assessing adversity was highlighted.
  • Strategies for engaging regulatory agencies in the decision-making process were discussed.

Conclusions:

  • The continuing education course provided valuable insights into the complexities of determining and communicating adversity.
  • Understanding and clearly communicating adverse effects are crucial for accurate toxicologic assessments.
  • Effective communication with regulatory agencies is essential for successful preclinical study interpretation.