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Your search keyword '"Manasco, Penelope K."' showing total 20 results
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20 results on '"Manasco, Penelope K."'

1. Adopting eISF for Remote Quality Oversight of Trials: Exploring the use of electronic investigator site files for review of regulatory documents and informed consents

Author

Manasco, Penelope K.

Subjects
Electronic records -- Evaluation, Medical research, Independent regulatory commissions, Technology, Backup software, Clinical trials, General interest, Health
Abstract

The adoption of using electronic systems in clinical research has been like watching a slow-moving train on a cross-country tour. Over the past 20 years, many technologies have been delivered [...]

Published
2019

2. Risk-Based Monitoring: Barriers to Adoption: Examining the barriers, challenges, and outcomes to determine the effectiveness of different RBM implementation approaches

Author

Manasco, Penelope K.

Subjects
Risk assessment -- Surveys -- Methods, Clinical research organizations -- Surveys -- Management, Pharmaceutical industry -- Surveys -- Management, Biotechnology industries -- Surveys -- Management, Company business management, General interest, Health
Abstract

In April and May 2018, I developed and conducted a survey of pharma, biotech, and CRO staff to better understand the barriers to adopting risk-based monitoring (RBM). I performed these [...]

Published
2018

5. A novel testis-stimulating factor in familial male precocious puberty

Author

Manasco, Penelope K., Girton, Mary E., Diggs, Richard L., Doppman, John L., Feuillan, Penelope P., Barnes, Kevin M., Cutler, Gordon B., Jr., Loriaux, D. Lynn, and Albertson, Barry D.

Subjects
Precocious puberty -- Genetic aspects, Precocious puberty -- Physiological aspects, Testis-determining factor -- Physiological aspects
Abstract

Familial male precocious puberty affects only males, and is characterized by early development of the sex organs. The disease is inherited, and is not related to the secretion of gonadotropin, a sex hormone. The disease is transmitted in the sex chromosomes and is a dominant trait, meaning that it is expressed even if it is carried on only one of the two chromosomes. Rapid growth and development of secondary sexual characteristics occur by the age of three. The genetic cause of familial male precocious puberty is unknown. Blood plasma was collected from 12 boys with familial male precocious puberty, 7 normal prepubertal boys, and 1 with hypogonadotropic hypogonadism (inhibited secretion of gonadotropin by the testes). This was then injected into the testicles of cynomolgus monkeys that had been pretreated with gonadotropin-releasing-hormone antagonist to inhibit the monkeys' natural secretion of hormones. Testosterone levels were then measured. The peak testosterone response was significantly greater in monkeys treated with blood from the 12 boys with familial male precocious puberty than in those receiving blood from the normal prepubertal boys. It would appear that there is a circulating testis-stimulating factor in boys with familial male precocious puberty. Such a factor explains the biological nature of the disorder. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

10. Pharmacogenetics and the Genetic Basis of ADRs.

Author

Manasco, Penelope K., Rieser, Patricia, Renegar, Gaile, and Mosteller, Michael

Abstract

The article focuses on pharmacogenetics and the genetic basis of adverse drugs reactions (ADRs). Pharmacogenetics is the study of genetic factors related to human variability in response to medicines. Incidental clinical observations during the late 1940s and 1950s resulted in the discovery of several relatively common genetic variations related to ADRs. Hemolysis related to anti-malarial treatment was much more common among African-American soldiers during World War II, leading to the identification of inherited variants of glucose-6-phosphate dehydrogenase. Most drugs are degraded via a limited number of metabolic pathways, most of which involve microsomal hepatic enzymes.

Published
2002

16. Ethical and Legal Aspects of Applied Genomic Technologies: Practical Solutions

Author

Manasco, Penelope K.

Abstract

Many ethical and legal issues surround genomic technologies, some of which are present for other kinds of medical data, but some of which are specific to genomic data. Specifically the global nature of genomic data and the life-long implications of genetic defects on the health of the individual subject produce challenges in the ethical and legal handling of this data. In general, data derived from transcriptome analysis, which studies gene expression, as well as proteomics and metabolomics, carry less ethically-charged information than measures of the germ line genome. However, theoretical issues that have been raised related to withholding therapy based on a specific genotype which could also apply to a specific expression profile. Potential solutions for these challenges are discussed, such as maintaining a connection with research participants through a trusted third party, using electronic means to manage that contact and reconsent subjects. A flexible, secure information technology infrastructure is proposed to manage and search consent forms, provide the ability to collect additional data and consent while maintaining participant confidentiality.

Published
2005

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