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Related Concept Videos

Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Types of Reports I: Hand-off Report01:25

Types of Reports I: Hand-off Report

A hand-off report, also known as a change-of-shift report, is a crucial nursing process that ensures the smooth transition of patient care responsibilities between nursing staff.
Following are the key components and categories of hand-off reports:
Purpose and Process:
Types of Reports II: Incident or Occurrence Report01:21

Types of Reports II: Incident or Occurrence Report

An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Data Reporting and Recording01:24

Data Reporting and Recording

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...
Quality Control01:05

Quality Control

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...
Data Validation01:03

Data Validation

Data validation is an essential part of a comprehensive assessment. Validation is confirming or verifying and opening the door to gathering more assessment data as it clarifies vague or unclear data. The process of checking and verifying the collected information is called data validation. The primary purpose of data validation is to ensure data is as free from error, bias, and misinterpretation as possible.
Nursing assessment guides are generally based on holistic models rather than medical...

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Standardization of Transfer across Labs between Flow Cytometers for Detection of Lymphocytes in Japanese Encephalitis Vaccinated Children
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Standardization of Transfer across Labs between Flow Cytometers for Detection of Lymphocytes in Japanese Encephalitis Vaccinated Children

Published on: February 10, 2023

Validation activities in Japan: a report.

Hiroshi Ono1

  • 1Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano-city, Kanagawa 57-8523, Japan. ono.h@fdsc.or.jp

Alternatives to Laboratory Animals : ATLA
|April 16, 2013
PubMed
Summary
This summary is machine-generated.

Japanese researchers validated alternative testing methods, including the Limulus endotoxin test and in vitro eye irritation tests. These efforts advance animal testing alternatives in toxicology and cosmetics.

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Published on: November 9, 2020

Area of Science:

  • Toxicology
  • Biotechnology
  • Regulatory Science

Background:

  • The Japanese Pharmacopoeia Society initiated validation of the Limulus endotoxin test as an alternative to the rabbit pyrogen test.
  • The National Institute of Health Sciences (NIHS) and cosmetic companies validated in vitro alternatives to the Draize eye test.
  • The Japanese Society of Alternatives to Animal Experiments (JSAAE) has promoted research on alternatives since 1989.

Purpose of the Study:

  • To review Japanese activities in validating alternative testing methods.
  • To assess the progress and scope of alternative method validation in Japan.
  • To highlight the collaborative efforts between regulatory bodies, research institutions, and industry.

Main Methods:

  • Validation studies for the Limulus endotoxin test (alternative to rabbit pyrogen test).
  • Validation of in vitro alternatives for the Draize eye test.
  • Interlaboratory reproducibility studies on cytotoxicity tests by JSAAE.
  • Cell transformation assays as adjuncts to carcinogenicity testing.

Main Results:

  • Successful validation of the Limulus endotoxin test under NIHS direction.
  • Validation of in vitro cosmetic eye test alternatives by NIHS and industry.
  • JSAAE conducted reproducibility studies on five cytotoxicity tests.
  • Ongoing planning for validation of in vitro local irritation tests.

Conclusions:

  • Japan has made significant progress in validating alternative testing methods across various toxicological applications.
  • Collaborative efforts involving regulatory agencies, research institutes, and industry are crucial for successful validation.
  • These advancements contribute to reducing animal testing in pharmaceutical and cosmetic safety evaluations.