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In the present study, a 8 x 4 mm biodegradable device was formulated using poly(ortho ester) and metronidazole for treatment of periodontitis. Investigation focussed upon determination of formulation parameters in the form of drug (metronidazole) and adjuvant concentrations (oleic acid and palmitic acid) and device thickness necessary to achieve constant release of 0.6 μg/hr over a period of 7 days and complete degradation of the device over a period of 11 to 13 days. Presence of oleic or palmitic acid influenced the release and erosion profile considerably. Thickness of the device did not have significant influence on the drug release. The DSC and NMR studies indicated absence of interaction between drug and polymer. Computer optimization studies indicate that the optimum formulation for 7 day constant drug delivery and disappearance in 13 days should contain 0.28% w/w of oleic acid and 5.26% w/w of metronidazole at the thickness of 400-450 or 500-550 μm. This is in close agreement with the optimum formulation which was obtained with the experimental data.

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This dissertation investigates the consequences of supply chain disruptions in pharmaceutical supply chains. Across different studies, I examine various impacts of pharmaceutical supply chain disruptions on buyer’s behavior, medication errors, and market share. In Chapter 1, coauthored with Anita Carson, Erin Fox, and Rena Conti, we demonstrate the stockpiling behaviors of buyers during the early phase of the COVID-19 pandemic. Leveraging a quasi-experimental design on IQVIA’s National Sales Perspectives™ data, we show that the sales volume of essential medicines related to U.S. hospital-based COVID-19 treatment concentrated only for the first two months of the pandemic. After these two months, the sales volume of drugs for COVID-19 treatment decreases significantly despite a nationwide increase in COVID-19-related hospitalizations. In Chapter 2, coauthored with Anita Carson and Rena Conti, we examine the impact of a hurricane that decimated the factories of major producers of heparin, an important drug used frequently in hospitals. Using a natural experiment, we find that the hurricane-related pharmaceutical supply chain disruption increased medication error rates of heparin. In addition, we find significant spillover effects. The supply chain disruption increased the medication error rates of a substitute drug. In Chapter 3, coauthored with Anita Carson and Rena Conti, we study how long it takes to recover the market share after the supply chain disruptions using a new metric we propose, Time to Recover Market Share. We explore the differential effects by the brand type of products, the competition level in markets, and the duration of the supply disruptions. With the extensive global supply chain disruptions that we are facing today, understanding their potential consequences is significant. This dissertation advances our understanding of the different impacts of supply chain disruptions and provides practical implications for supply chain members to build resilient supply chains and minimize the effects of supply chain disruptions.

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On June 8, 2006, Merck announced the debut of Gardasil, the world's first vaccine found successful in preventing human papillomavirus (HPV) infections, a sexually transmitted infection that is one of the main causes of certain cancers in men and women, including cervical, vulvar, penile and anal cancers. To promote the vaccine's release, Merck launched Gardasil's "One Less" advertising campaign that included television commercials, print ads and a consumerfocused website (www.Gardasil.com), each promoting the message that "you" could now be "one less woman" affected by cervical cancer ("One Less" campaign). The vaccine, tested and approved only for females age 9-26, was advertised to this age group, as well as parents or guardians responsible for making medical decisions for female minors. As the campaign launched, commercials depicted females laughing and enjoying hobbies while mentioning the positive decision they made to receive the Gardasil vaccine. Many commercials also included portrayals of mothers talking happily about their decision to get their young daughters vaccinated. Interestingly, male figures were completely left out of Gardasil's "One Less" campaign ads, despite the fact that in reality, males administer the vaccine as medical professionals, transmit the infection as sexual partners, and suffer cancers as HPVinfected patients. Males were even left out of the ads as parents, who were always portrayed by women in the ad campaign. iv Informed consumers may have expected all this to change on Oct. 16, 2009 – three years after Gardasil's debut – when the Food & Drug Administration (FDA) approved the vaccine for use in males age 9-26 to protect against HPV-caused genital warts. Though Merck's vaccine was now accessible to more consumers than ever, the advertising that surrounded this medical breakthrough changed very little. Television commercials for the vaccine still promoted Gardasil primarily to women for the purpose of preventing HPV-related cervical cancer. Again, men were not featured in commercials as medical professionals, parents, guardians, romantic partners, or even as patients able to get the vaccine. Males did begin appearing on the vaccine's official website, however these depictions were limited to showing only young boys, who appeared standing with a mother's protective arm around them. Males that represent the older age range (up to age 26) were never shown. What effect does the lack of male representation have on the verbal and nonverbal message these ads are sending consumers about who fits in the target consumer group, as well as who is at risk for an HPV infection? On a broader level, how does gender representation as a whole affect pharmaceutical advertisements and the adoption of the potentially life-saving products they promote? How does a pharmaceutical technology become "gendered"? How do specific gender portrayals impact the educational aspects of pharmaceutical ads, which may shape a consumer's opinion of who is at risk for an illness, and who is responsible for its treatment or prevention? And how do these gender portrayals connect with, reflect or reinforce v dominant cultural beliefs about the roles males and females play in protecting themselves and others from disease? In this study, I investigate these questions using a blended cultural studies/social sciences research perspective, first looking at the controversial history of direct-toconsumer pharmaceutical advertising and the gender stereotypes that traditionally exist in this form of rhetoric. I then test the affect Merck's gender portrayals has on its ad message in a blind study done with a small sample population, which provides evidence that Merck's ads are confusing and exclusive of certain populations, particularly men. I then investigate how Merck's existing gender portrayals, and strong focus on women, reflect larger historical beliefs on the roles that males and females play in health care and in the family. I show how, through advertising, Gardasil has become "gendered" as a pharmaceutical technology for female children. From here, I will show how pharmaceutical companies, such as Merck, have both reflected and reinforced the belief that women are the primary caregivers to children, how this stereotype is both damaging and statistically incorrect, and how using it targets Gardasil ads to a very narrow population of consumers, miscommunicating the message of who is at risk for illness contraction and perhaps even damaging sales in addition to prevention. I later provide evidence that Merck's current Gardasil ad series and other actions in the marketplace are dangerously misleading certain populations regarding the nature of the HPV virus, the protective abilities of the vaccine, and the populations responsible for accessing Gardasil. I then provide the argument that gendering Gardasil as a "women's technology" is done intentionally by Merck, which has a history of making vi profits a priority over responsibly treating patient health. I conclude by providing detailed suggestions on how Merck can augment their current ad series to de-gender Gardasil to become more medically responsible, and break out of the cycle of portraying men and women using damaging and outdated stereotypes. Instead, my suggestions for changes to Gardasil's advertising approach would make the vaccine's messages appeal to all audiences at risk.

This study evaluates soil properties that impact the effectiveness of soil aquifer treatment (SAT) as a polishing step to the remove two classes of ECs from wastewater effluent: pharmaceuticals and personal care products (PPCPs), and engineering nanomaterials (ENMs). In recent years, it has been determined that elevated levels of emerging contaminants (ECs) are being released into the environment with wastewater effluent. ECs are proven to cause adverse environmental and health effects as a result of long-term exposure. It is important to evaluate sustainable solutions to improve the current methods of wastewater treatment to address these ECs. Soil aquifer treatment (SAT) is a sustainable, cost effect treatment alternative to advanced treatment at a wastewater treatment plant. SAT replenishes local groundwater supplies while allowing for indirect potable reuse, if contaminants of concern such as ECs can be effectively removed from the water. Since wastewater effluent can contain a variety of contaminants with myriad physical and chemical properties, understanding the potential of the aquifer itself to provide EC removal is a key step in establishing SAT as a viable treatment alternative. Peer-reviewed research studies were analyzed to determine the soil properties that affect the fate and transport of ECs in the aquifer environment. The data was complied to produce recommendations for an effective SAT site. Physical and chemical properties of the soil facilitate contaminant removal as the groundwater flows through the aquifer. This study determined that removal of ECs from effluent had a correlation with (1) high clay content, (2) small Darcy Velocity, (3) high soil organic matter content, and (4) low sand content. Based on the 6 peer-reviewed research studies reviewed, the removal of nanomaterials is affected by clay content and sand content, but not soil organic matter content. Conversely, the removal of PPCPs is affected by clay content and soil organic mater content, but not sand content. It can be concluded that two different removal mechanisms facilitate the removal of nanomaterials versus PPCPs; physical removal for nanomaterials and chemical removal (sorption) for PPCPs. Clay facilitates the removal of both contaminants. The small soil diameter of clay forms smaller pores in the soil media. This causes increased pore straining, while also restricting the flow through the soil, which increases the contact time between the soil particle and the ECs. Additionally, clay has a large surface area, which increases surface interactions, such as sorption, of the EC to the surface of the clay particle.

The population pharmacokinetics and pharmacodynamics (PK/PD) of nevirapine (NVP), zidovudine (ZDV), and didanosine (ddI) were evaluated in 432 pediatric patients with HIV, randomized to receive either a double-therapy of ZDV + ddI or NVP + ddI; or triple-therapy of NVP + ZDV + ddI as a substudy of the AIDS Clinical Trials Group Protocol 245 in 2 phases. In phase 1, nonlinear mixed-effect modeling (NONMEM) analysis was employed for population pharmacokinetics (PPK) study for ZDV, ddI and NVP. One-compartment model with first-order input and first-order elimination was fitted to the NVP, ZDV and ddI data. Final PPK models were as follows: ZDV; CL (1/hr, without nevirapine coadministration) = 52.4 × BSA, CL (1/hr, with nevirapine coadministration) = 65.0 × BSA, Vd/F(1) = 116 × BSA, ddI; CL (1/hr) = 73.4 × BSA + 69.9, Vd/F(1) = 132, and NVP; CL (1/hr) = 2.30 × BSA, Vd/F(1) = 120. In phase 2, the relationship between the predicted serum concentrations of ZDV, ddI, and NVP and pharmacodynamic responses were evaluated via S-Plus ® exploratory data analysis. No apparent relationship between average steady-state serum concentrations and pharmacodynamic variables, such as HIV-1 RNA(RNA) levels, CD4 + count was found. However, the responses of RNA level and CD4 + count to the double therapy (ddI/NVP) versus triple therapy (ddI/NVP/ZDV) were significantly different after 4 weeks of therapy ( P = 0.0014 for RNA level at week 4, P = 0.0454 for CD4 + count at week 12). No significantly different responses were found in weight changes ( P > 0.25 at all weeks). Also, the maximum drop of RNA level throughout the treatment period had a strong relationship to the decline slope of RNA at week 4 as follows: Maximum drop of RNA = 3.1139 × RNA decline slope at week 4 - 0.411. Nevirapine dosing regimens were compared using simulation via Trial Simulator™. Both ACTG regimen (body surface area based) and manufacture's regimen (age and weight based) produced similar concentrations at lower end concentration but manufacture's regimen produce higher concentration at upper end with 1000 simulated patients (ACTG regimen; 2150, 3827, and 4992 ng/ml, manufacturer's regimen; 2066, 4130, and 6568 ng/ml, for 10 th , 50 th , and 96 th percentile, respectively). It is suggested to use body surface area based dosing regimen for NVP.

Using a multiple baseline design, this study examined the effect of preferred items in increasing medication knowledge among individuals diagnosed with a mental illness. Participants were asked questions regarding their Haldol medication. After baseline, participants received the answers and a pharmacy-generated medication profile. During the Repeated Trials intervention, participants were given only verbal feedback. Those who had not reached criterion after 4 weeks entered the Preferred Trials intervention. In this phase, participants received a high, medium, or low preferred item contingent on the number of correct answers. All participants increased their number of correct answers. Although the effects of a contingent preferred item were mixed, this study showed that information regarding medications can be learned with minimal staff intervention.