PubMed Health⌕ Search

Biomedical subjects

R W Usher

Publications and source records attributed to R W Usher.

7 recordsLinked to original sources
PubMed1995

Beyond computer validation - a new role for quality assurance in systems development.

The Quality Assurance Unit (QAU) at Eli Lilly and Company is involved in the development of a new clinical pathology computer system in conjunction with the information systems area and the user area. This is the first time that the QAU had the opportunity to build our requirements into a new computer system. This is a new role for QA and includes both auditing and validation personnel who offer QA insights into issues. Benefits of QA involvement in the developmental process include saving time by building quality checks into the system, thus eliminating the need for manual review later in the process. Early resolution of issues leads to significant financial savings. Other benefits include improved communication among the three functional areas and a better understanding of the requirements and work processes. The team approach to the development of a new computer system results in a high-quality final product which meets all user and regulatory requirements, while also providing additional benefits to our organization.

Efficiency, Organizational↗
PubMed1995

Developing an effective toxicology/quality assurance partnership. Improving quality, compliance, and cooperation.

Toxicology and Quality Assurance (QA) at Eli Lilly and Company are well integrated, yet still independent organizations that are aligned with the same overall business objective: to efficiently deliver a high-quality product to the customer. One of the keys to success has been the implementation of a monitoring/metric and trend analysis program of key work processes that are central to the delivery of final product. Our metrics program indicates that the multiple changes that we have made have resulted in a higher quality product. This paper will discuss the practical changes we have made as a part of our Total Quality journey. This article is based solely on the authors' experiences while at Eli Lilly and Company.

Communication↗
PubMed1994

Good research practices: a commonsense approach to ensuring quality in research facilities.

This guideline can be a useful tool for assisting and assessing "non-GLP" laboratories in academic and contract settings. This guideline has proven useful in assessing academic and/or contract labs where a final product is needed which would meet FDA expectations for preclinical or clinical research. Because of differing research settings and study types, we apply the standards in a flexible manner. For example, in some settings, the study plan is simply documented in a research notebook as the study unfolds, whereas in other settings a written protocol (which is signed by the principal investigator) is in place prior to study initiation. Additionally, all criteria may not be applicable to every research facility. The focus of this guideline is to ensure that sufficient documentation exists which will allow for study reconstruction and to provide adequate evidence that the raw data generated by the facility are accurate. This guideline is a useful tool for Quality Assurance personnel and can also be used by research personnel in the development of appropriate quality systems for their research environment.

Biological Assay↗
PubMed1991

Efficacy and safety of morning versus evening fluoxetine administration.

A total of 120 patients who met DSM-III criteria for unipolar major depressive episode were equally randomized to fluoxetine a.m. or fluoxetine p.m. treatment groups, such that 30 patients were in each group at each of two sites. Patients received 20 to 80 mg of fluoxetine every day for 5 weeks; the dose was based on clinical response. Highly significant within-treatment improvement was reflected by changes in mean scores on the Hamilton Rating Scale for Depression (total score and factors), the Raskin Depression Scale, the Covi Anxiety Scale, the Clinical Global Impressions Scale for Severity, and the Clinical Global Impressions Scale for Improvement. No significant differences occurred between the a.m. and p.m. groups for any efficacy variable. Evaluation of adverse events and vital signs indicated no clinically significant differences between the two treatment groups. The data indicate that fluoxetine is equally efficacious and well tolerated regardless of the time of day it is administered and suggest that fluoxetine may be administered at either time of day without affecting clinical course.

Adolescent↗
PubMed1987

Chronic dietary oncogenicity studies of indecainide in rats and mice.

Chronic toxicity and oncogenicity studies of indecainide, an antiarrhythmic compound, were conducted in Fischer 344 rats and B6C3F1 mice at dietary concentrations of 0.0, 0.02, 0.04, or 0.08%. Sixty animals per sex per dose of each species were tested. The duration of compound administration was 2 years for both species. The average daily dose was 9.0, 18.0, or 37.0 mg/kg for rats and approximately 27.0, 53.0, or 113.0 mg/kg for mice. In rats, no biologically significant changes were seen with respect to mortality and clinical signs. Body weight gain and daily food consumption were significantly depressed in the 0.08% dose group males and 0.04 and 0.08% females. Treatment with indecainide had no toxicologically important effects on hematologic or clinical chemistry parameters or on organ weight values. Centrilobular fat deposition was present in the livers of males in the 0.04 and 0.08% dose groups. The incidence of benign and malignant tumors in the treated groups was not increased by treatment with indecainide. Survival of B6C3F1 mice was not significantly affected by exposure to indecainide. Mean body weight gain was slightly decreased throughout the study in mice receiving 0.02 or 0.04%, while mice receiving 0.08% indecainide had moderately decreased body weight gain. Treatment with indecainide had no toxicologically important effects on the hematologic or clinical chemistry parameters measured. No biologically important effects were observed in organ weight values. The incidence of non-neoplastic and neoplastic lesions was similar to those associated with aging in this strain and these were considered to be unrelated to drug treatment. Based on the findings in these studies, indecainide was not carcinogenic to either F344 rats or B6C3F1 mice at dietary concentrations of 0.02, 0.04, or 0.08% for 2 years.

Administration, Oral↗
PubMedDate not supplied

How to measure the effectiveness of quality assurance.

Measuring is an essential component of any Total Quality Management System. In the Good Laboratory Practices arena this normally is done by measuring the quality of the customer's (e.g. Toxicology) output. This paper describes a holistic approach to measuring the effectiveness of the Quality Assurance Unit (QAU), which includes measures of both the customer and the QAU. When taken together, these measures provide management with a picture of the effectiveness of the QAU.

Consumer Behavior↗