Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories

Ezzelle, J.; Rodriguez-Chavez, Isaac R.; Darden, Janice M.; Stirewalt, Michael; Kunwar, Nina; Hitchcock, Rowena; Walter, T.; D’Souza, M. Patricia

doi:10.1016/j.jpba.2007.10.010

Cited by 138 publications

(92 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The laboratory complies with the principles of Good Clinical Laboratory Practice. 19,20 Children with abnormal clinical or laboratory test results were referred for appropriate care and treatment.…”

Section: Methodsmentioning

confidence: 99%

Biochemical and Hematologic Parameters for Children in the Middle Belt of Ghana

Dosoo

Asante

Kayan³

et al. 2014

The American Society of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

Abstract. Reference values derived from developed countries are used in many countries in Africa for interpretation of laboratory results obtained during routine healthcare and clinical trials. Use of locally derived reference values has been recommended. The purpose of the study was to establish age-and sex-specific reference values for children in the middle belt of Ghana. Reference values were determined for 21 biochemical and 18 hematologic parameters by using Clinical and Laboratory Standards Institute C28-A3 guidelines in a sample of 1,442 healthy children. Hemoglobin, hematocrit, mean cell volume, erythrocytes, urea, and creatinine were lower when compared with values from northern countries but alanine aminotransferase, aspartate aminotransferase, and total bilirubin were higher. A panel of locally relevant age-and sex-specific reference values was established for commonly used biochemical and hematologic tests in children in the middle part of Ghana. This will help in interpretation of laboratory results for clinical management of patients, screening, and safety monitoring during clinical trials.

show abstract

Section: Methodsmentioning

confidence: 99%

Biochemical and Hematologic Parameters for Children in the Middle Belt of Ghana

Dosoo

Asante

Kayan³

et al. 2014

The American Society of Tropical Medicine and Hygiene

View full text Add to dashboard Cite

show abstract

“…In this case, a correction factor based on the value of MR can be applied to the results from the new lot. The importance of the use of a correction factor when lot-dependent performance changes are observed has also been discussed elsewhere, and the reader is referred to these papers (26,27). The use of a correction factor may be considered to compensate for content and proportional errors if experimental data have been generated and are available to support.…”

Section: Solving Challenges With Lot-to-lot Differencesmentioning

confidence: 99%

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Jani

Allinson²,

Berisha

et al. 2015

AAPS J

View full text Add to dashboard Cite

Abstract. Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-forpurpose-based validation, emphasizing issues that are unique to multiplex kit assays.

show abstract

“…Then, after obtaining sufficient ethical approvals and consent forms, blood sampling could be gathered by a trained client under the guidance of existing guidelines [12,13]. In clinical trials on pediatric psychiatry, a team-based approach involving the laboratory physician would help the quality assurance of examination, diagnosis, and reporting, as well as patient safety [14,15].…”

Section: Protection Of Trial Subjectsmentioning

confidence: 99%

Good Clinical Practice in Children and Adolescents

Mohammadi¹,

Mostafavi²

2018

Clinical Trials in Vulnerable Populations

View full text Add to dashboard Cite

Good clinical practice (GCP) is a series of systematically developed ethical and quality standard of designing, registering, running, recording, and reporting of the clinical trials. Good clinical practice is very important regarding the trials usually performed on the vulnerable populations especially children and adolescents. The sensitivity of the issue is even higher in the children with psychiatric disorders. Usually, these children have little legal protection. Hence, the safety of interventions and the ethical considerations are among the most important issues in this field. The purpose of this chapter is to deal with above problems and globally applicable standards for the conduct of clinical trials on the under legal age subjects especially those with psychiatric disorders. Selection of trial subjects, ethical principles, regulatory requirements, protection of trial subjects, monitoring (compliance with the protocol), responsibilities of the investigator, and other requirements to perform a clinically and ethically sound clinical trial in children and adolescents will be discussed in this chapter.

show abstract

Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories

Cited by 138 publications

References 8 publications

Biochemical and Hematologic Parameters for Children in the Middle Belt of Ghana

Biochemical and Hematologic Parameters for Children in the Middle Belt of Ghana

Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development

Good Clinical Practice in Children and Adolescents

Contact Info

Product

Resources

About