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Comparison Of Post-Marketing Surveillance Approaches Regarding Infections Related To Tumor Necrosis Factor (Tnf) Inhibitors, Cheng Chen Jul 2017

Comparison Of Post-Marketing Surveillance Approaches Regarding Infections Related To Tumor Necrosis Factor (Tnf) Inhibitors, Cheng Chen

Pharmaceutical Sciences ETDs

Objective: Both spontaneous (voluntary) reporting systems and observational approaches serve as important tools in post-marketing surveillance for adverse drug events, however, each has its own advantages. The primary purpose of this project was to compare and contrast the FDA Adverse Event Reporting System (FAERS) data and findings from observational studies in post-marketing surveillance through examining TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab and golimumab) related infections, and secondarily, to examine the applicability of additional analyses in FAERS, such as multiple logistic regressions and time to onset of event analysis.

Methods: Using MedDRA® preferred terms (PTs), infection and infestation cases in …


Comparing The Effectiveness Of Using Educational Booklet Or Brief Video On Patients’ Knowledge, Perceptions And Willingness To Participate In Placebo-Controlled Clinical Trials, Khalid F. Almoaikel, Dennis Raisch, Matthew Borrego, Mike Sather, Mark Holdsworth May 2017

Comparing The Effectiveness Of Using Educational Booklet Or Brief Video On Patients’ Knowledge, Perceptions And Willingness To Participate In Placebo-Controlled Clinical Trials, Khalid F. Almoaikel, Dennis Raisch, Matthew Borrego, Mike Sather, Mark Holdsworth

Pharmaceutical Sciences ETDs

Background and Objectives: Limited knowledge about clinical trials can influence a patient’s willingness to participate in medical research. For placebo-controlled clinical trials, it is more difficult to recruit patients compared to clinical trials without a placebo arm. Thus, educating individuals about clinical trials and placebos can potentially improve their perceptions about clinical trials and might increase their willingness to enroll in them. The study objectives include:

1) To design educational interventions (a booklet and a video) to improve a patient’s knowledge of placebo controlled clinical trials.

2) To compare the impact of the educational interventions (booklet, video or both) on …


Role Of Nuclear Pharmacist In Clinical Translation Of Positron Emission Tomography (Pet) Radiopharmaceuticals And Environmental Monitoring Of Facility, Reiko Oyama Jan 2017

Role Of Nuclear Pharmacist In Clinical Translation Of Positron Emission Tomography (Pet) Radiopharmaceuticals And Environmental Monitoring Of Facility, Reiko Oyama

Pharmaceutical Sciences ETDs

There have been many changes in nuclear medicine and molecular imaging field as several radiopharmaceuticals have recently been approved and many others on the horizon. Ensuring the compliance with the increasingly aggressive national, federal, and state regulatory has become a critical piece of PET manufacturing and Nuclear Pharmacy.

As a nuclear pharmacist, I have been searching for the way I can better contribute to the progress of this field with an ultimate goal of proving safe and effective healthcare to the patients. In order to do so, strengthening my expertise is essential. In this thesis, I would like to capture …