Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Sensitivity, Specificity, and Predicted Value01:13

Sensitivity, Specificity, and Predicted Value

1.7K
In healthcare diagnostics, laboratory tests play a crucial role in identifying and diagnosing a wide range of medical conditions. However, interpreting test results is not always straightforward. An abnormal test result does not always confirm the presence of a disease, just as a normal result does not guarantee its absence. To assess the reliability of these diagnostic tools, healthcare practitioners rely on two key statistical indicators: sensitivity and specificity.
Sensitivity is the...
1.7K
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

247
In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
247
Bioequivalence Data: Statistical Interpretation01:16

Bioequivalence Data: Statistical Interpretation

307
The statistical interpretation of bioequivalence data is a significant aspect of pharmaceutical research. Bioequivalence refers to the absence of any significant difference in the rate and extent to which the active ingredient in pharmaceutical products becomes available at the site of drug action when administered at the same molar dose under similar conditions. This helps determine if different drug products have similar absorption rates, ensuring their interchangeability.Statistical...
307
Methods of Documentation III: PIE01:21

Methods of Documentation III: PIE

2.1K
Problem-intervention-evaluation (PIE) is a systematic approach to documentation used in healthcare settings for clinical decision-making and patient care planning. It is a structured approach to organizing patient data based on problems, interventions, and evaluations. Here's a breakdown of its key features and considerations:
2.1K
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

279
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
279
Data Reporting and Recording01:24

Data Reporting and Recording

5.6K
Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
5.6K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Naphthoquine-induced Central Nervous System and Hepatic Vasculocentric Toxicity in the Beagle Dog.

Toxicologic pathology·2016
Same author

Deciphering Sources of Variability in Clinical Pathology.

Toxicologic pathology·2016
Same author

Factors affecting urine reagent strip blood results in dogs and nonhuman primates and interpretation of urinalysis in preclinical toxicology studies: a Multi-Institution Contract Research Organization and BioPharmaceutical Company Perspective.

Veterinary clinical pathology·2015
Same author

Best practices for clinical pathology testing in carcinogenicity studies.

Toxicologic pathology·2011
Same author

Refinement of the urine concentration test in rats.

Contemporary topics in laboratory animal science·2005
Same author

Factors affecting the interpretation of canine and nonhuman primate clinical pathology.

Toxicologic pathology·2003
Same journal

Comparison of Standard Clinical Pathology Parameter Values in Fasted and Fed Rats and Non-human Primates.

Toxicologic pathology·2026
Same journal

Time-Dependent Autolysis in Ex Vivo-Maintained Rat Tissue in Saline: A Descriptive Study and Practical Guidance for Histopathologic Assessment.

Toxicologic pathology·2026
Same journal

New Approach Methodologies (NAMs) for Carcinogenicity Evaluation.

Toxicologic pathology·2026
Same journal

2025 International Academy of Toxicologic Pathology (IATP) Satellite Symposium: Pathology Working Groups (PWGs) in Toxicologic Pathology.

Toxicologic pathology·2026
Same journal

Toxicologic Pathology Forum*: Opportunities and Challenges in the Use of Artificial Intelligence in Nonclinical Toxicologic Histopathology Evaluations.

Toxicologic pathology·2026
Same journal

New Modalities and Carcinogenicity Assessment.

Toxicologic pathology·2026
See all related articles

Related Experiment Video

Updated: Mar 13, 2026

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
14:45

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay

Published on: September 16, 2012

15.6K

Practical Considerations in Clinical Pathology Data Interpretation and Description.

Robert L Hall1

  • 11 Palm Coast, FL, USA.

Toxicologic Pathology
|October 13, 2016
PubMed
Summary
This summary is machine-generated.

Interpreting preclinical safety test results requires a consistent approach, yet companies vary in methods like statistical analysis and reference intervals. Flexibility is key due to unique study conditions.

Keywords:
clinical pathology datadata interpretationreference intervalseverity modifiersstatistical analysis

More Related Videos

Introduction of an Integrated Pathology Image Management, Artificial Intelligence, and Reporting System
05:33

Introduction of an Integrated Pathology Image Management, Artificial Intelligence, and Reporting System

Published on: July 11, 2025

1.3K
Standardized SDS-PAGE Workflow for Personalized Protein Corona Profiling in Early Cancer Detection
10:02

Standardized SDS-PAGE Workflow for Personalized Protein Corona Profiling in Early Cancer Detection

Published on: December 19, 2025

664

Related Experiment Videos

Last Updated: Mar 13, 2026

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
14:45

Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay

Published on: September 16, 2012

15.6K
Introduction of an Integrated Pathology Image Management, Artificial Intelligence, and Reporting System
05:33

Introduction of an Integrated Pathology Image Management, Artificial Intelligence, and Reporting System

Published on: July 11, 2025

1.3K
Standardized SDS-PAGE Workflow for Personalized Protein Corona Profiling in Early Cancer Detection
10:02

Standardized SDS-PAGE Workflow for Personalized Protein Corona Profiling in Early Cancer Detection

Published on: December 19, 2025

664

Area of Science:

  • Toxicologic Pathology
  • Preclinical Safety Assessment

Background:

  • Companies utilize diverse methods for interpreting preclinical safety test results.
  • Variations exist in statistical analysis, use of reference intervals, and effect description.

Purpose of the Study:

  • To address and highlight the differences in interpreting clinical pathology data.
  • To emphasize the need for a flexible "consistent standard approach" in preclinical studies.

Main Methods:

  • Review of differing company approaches to preclinical data interpretation.
  • Discussion of statistical analysis, reference intervals, and effect severity descriptors.

Main Results:

  • Significant company-to-company variation in interpreting and presenting preclinical safety data.
  • Disagreement on the necessity of statistical analysis and reference intervals.

Conclusions:

  • A "consistent standard approach" to preclinical safety testing must incorporate flexibility.
  • Study-specific conditions necessitate adaptable interpretation methods for accurate safety assessment.