University of Notre Dame
Browse
- No file added yet -

Developing Screening Technologies for Low Resource Settings

Download (8.16 MB)
thesis
posted on 2020-11-24, 00:00 authored by Sarah L. Bliese

Analytical instrumentation is critical for regulating medicine and environmental quality, yet in many low- and middle-income countries (LMICs) a lack of technological infrastructure prevents regulatory agencies from responding effectively to problems that affect the health of their populations. The goal of my thesis work was to determine if screening technologies could be used to help LMIC regulatory agencies bridge this gap. During my thesis research, I created novel screening tools based on paper analytical devices (PADs), performed field tests to show that these screening devices are sensitive, specific, and usable by LMIC regulators. I also managed a program that coordinated quality determination of pharmaceutical samples from LMICs, and helped model the regulatory and economic impact of screening medicine quality in Kenya.

I collaborated with medicine regulatory agencies in Bangladesh and Tanzania to conduct specificity and sensitivity studies of paper analytical devices used for rapid screening of pharmaceuticals. Through these projects, I trained 55 drug inspectors on using the PAD and ten on how to fabricate the PAD locally in Bangladesh. The previously published PAD could not detect solid dosage forms that were degraded or substandard, but I showed that PAD analysis of liquid dosage forms coupled with principal component analysis could differentiate adulterated, degraded, and falsified ceftriaxone which allows for a more effective regulatory response to those products. To increase access to confirmatory analysis, I coordinated the Distributed Pharmaceutical Analysis Laboratory (DPAL), a network of twenty-nine academic institutions. During my time as coordinator, the program tripled in size, over one thousand samples were analyzed, and over one hundred substandard products were reported to medicine regulatory agencies. I helped a group at UNC-Chapel Hill to model market turnover rates, prevalence of substandard and falsified products, and detection efficiency based on our sample metadata. The model shows that using the PADs as a rapid screening discovered poor quality amoxicillin ten months sooner than compendial testing alone and allowed for removal of those products more frequently. The PADs used along with confirmatory testing averted 586 child deaths annually compared to confirmatory testing only.

Stepping away from pharmaceuticals, I also developed a test card for monitoring carbon monoxides levels, temperature, and humidity for use in low resources settings. The device can quantitatively respond within the permissible exposure level and the immediately dangerous to life and health level for carbon monoxide.

History

Date Modified

2020-12-18

Defense Date

2020-11-18

CIP Code

  • 40.0501

Research Director(s)

Marya Lieberman

Degree

  • Doctor of Philosophy

Degree Level

  • Doctoral Dissertation

Alternate Identifier

1227105879

Library Record

5951859

OCLC Number

1227105879

Program Name

  • Chemistry and Biochemistry

Usage metrics

    Dissertations

    Categories

    No categories selected

    Keywords

    Exports

    RefWorks
    BibTeX
    Ref. manager
    Endnote
    DataCite
    NLM
    DC