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Clinical Research administration Projects 

2018

Restructuring a Regulatory Team: The Effect on New Study Approval Timelines, Aneta R. Leavitt
A Comparative Meta-Analysis of Cardiovascular Risk During the Treatment of Adult Age ADHD with Mixed-Salt Amphetamine and Methylphenidate Compounds
, Nicholas Hill

The Effectiveness of Eastern Michigan University’s Institutional Review Board, DeQuindalyn D. Moore

Use of Nonsteroidal Anti-Inflammatory Agents and Risk of Melanoma and Non-Melanoma Skin Cancer, Santhosh Reddy Mukkisa

2017

The Effect of Shorter Review Times on Drug Safety Information, Dawud Ellayan

An Evaluation of the Readability of Drug Trials Snapshots, Sharada Lanka

Clinical Trials in India: History, Current Regulations, and Future Considerations, Kalindi Naik

Effects of FDA Imposed Pediatric Initiatives since 1997; Expectations vs Actualizations, Devon Sivhra

Drug Lag Analysis of New Molecular Entities (NMEs) in the United States and Europe, Sandhya Deore

2016

Evaluating the Need for an Orphan Drug Act in India by comparing it with the US Orphan Drug Act of 1983,  Dhirenvijaykumar Aaytee

An analysis of trends in drug advertising violations based on Warning letters & Untitled letters issued by the US FDA ,  Chavan Chetanshaligram 

“Drug Lag” analysis of New Molecular Entities between the United States and Europee, Vivekdasharath Deore 

Evaluation of Factors Associated with Human Papilloma Virus (HPV) Vaccine Acceptability in Parents of Adolescents, Sravankumar Goli

Are the Strategies Taken by the FDA Effective in Combating Counterfeit Drugs?, Rakesh Padigala

2015

A Case Study of Serious Adverse Event Reporting: Chantix, Zainab Jafar

An Analysis of Factors in the Approval of Orphan Drugs for the Rarest Diseases, Sadeepa Munasinghe

Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials, April M. Nelson

Comparison of the Dietary Supplements Use in the U.S. And Developing Countries: 2003-2015, Nutandeepthi Ponnada

Correlation between General Population Suicide Rates and NIH Funding in the United States, Noel B. Ramsey

Eastern Michigan University Human Subjects Review Committee: Analysis of Review Times, Mrunmayee Samant

Cyclical Health Patterns in Alzheimer’s Patients and Caregivers, Christopher Schneider

2014

US vs. Foreign Source of Counterfeit Drugs Found in US, Sruthi Akavaram

Analysis of FDA Safety Alerts from 2003 to 2012Prathuyusha Devireddy

Does Priority Review Result in a Higher Frequency of Drug Withdrawals From the Market Than Standard Review, Apoorva Gudimella

Long-term use of Autologous Serum Eye Drops for the Treatment of Dry Eye Disease, Munira T. Hussain

Relationship between Cancer Incidence, Mortality Rates and Funding, Sowmya Mallela

Deviations from Ethical Drug Promotion in India, Srilakshmi Medavarapu

Analysis of the impact of FDA labeling revisions:  The Fentora case study, Gopal Reddy Palvatla

Protection of Subjects and Regulation of Clinical Trials in India, Deepthi Pandiri

Review of Warning Letters Issued to Clinical Investigators During The Years 2002 to 2011, Pratyusha Bedadala

Cost Comparison of Medical Treatment in the United States vs India for Uninsured Americans, Jahnavi Vellanki

Percentage of Non-Caucasians in Clinical Trials from 2000 to 2009, Meghanadh Yerram

2013

Are the strategies employed by FDA efficient to resolve Drug Shortages?, Narotham Bantaram

Differences in the Collection of Clinical Trial Safety Information: United States Versus India, Nikhila Devireddy

Do the Differences in Worldwide Labeling for Some Drugs Correlate with Known Metabolic Variations in Different Races?, Girish Kankipati

Regulatory Challenges in the Manufacturing, Adverse Event Reporting and Marketing of Combination Products, Lavanya Kasaraneni

Are the strategies undertaken by the FDA effective in minimizing the illegal sales of online medicines?, Mani Mudumba

Risk Minimization Strategies in the USA, EU, Japan: How Developing Countries May Benefit, Uday K Singathi

Comparison of Prescription Procedures between Developed Countries and India- Suggestions on How to Minimize the Prescription Errors in India, Sandeep Kumar Thudi

Regulatory Issues with Current Dietary Supplement Regulations in the U.S.: Have Politics Triumphed over Science?, Soujanya Vidiyala

2012

Can the Reasons for Class-I Device Recall Be Predicted Prior to Regulatory Approval?, Mangala Deepthi Betha

Is a Personalized Approach to Lung Cancer Therapy a Less Toxic, Life Extending Option for Lung Cancer Patients?, Anusha Kakarala

Cardiologist’s Perceptions of Generic Drugs:  Are there Hurdles in Generic Substitution, Prashant Kyadhari

Do Articles in Medical Journals Provide Required Information to Assess the Validity of Clinical Trials with Negative Results, Rambabu Koritala

How to Effectively Guide Parents on the Discussion of Autism-Vaccine Controversy , Cinderalla Harry Saru

Therapeutic Cloning and its Effect on Women, Myeashia T. Stewart

Changes to Prescription Drug Pediatric Labeling: Awareness by Practicing Pediatricians, Siva Rama Krishna Thottempudi

Boundaries, Limitations and the Parental Perception of Newborn Research in the Neonatal Intensive Care Unit, Stephanie A. Wiggins

Seeking Predictable Subject Characteristics That Influence Clinical Trial Discontinuation, Jai Shankar K.B. Yadlapalli

Regulation of Herbal Dietary Supplements: Is There a Better Way?, Annet Zakaryan

2011

What is the current status of the use of Amyloid-b therapy for the prevention of Alzheimer’s Disease, Kiran Chaudhary

Impact of Targeted Therapy on Overall Survival in Advanced Kidney Cancer; a population based analysis of the National Surveillance Epidemiology and End Results (SEER) Registry Database, Supraja Chalasani

Are Pharmaceutical Market Withdrawals Preventable?, Jaya Sai V. Daggumalli

Alzheimer’s disease: A Comprehensive Overview and a Look into the Future, Ryan Drzewicki

How have FDA Warning Letters to Pharmaceutical Industry Changed since the Implementation of the new Bioresearch Monitoring Compliance program Guidance manuals in 2001?, Ravi Duddelli

Preventive Diabetic Care: Race/Ethnicity vs. Socioeconomic Status, Justin Jones

Volunteer Recruitment For Bioavailability and Bioequivalence Studies, Shilpa Lakkam

What are the Strategies being Employed to Increase the number of approved medical products, Rahshell Stephens

Therapeutic Cloning and its Effect on Women, Myeashia Stewart

What is the medical benefit of Computed Coronography Tomographic Angiography, Eric Weber

Are Mastectomies on the rise in Mercy Health system, Toledo, Ohio? A 14 Year trend analysis of the selection of Mastectomies vs. Breast Conservation Therapy, Saikrishna Velagapudi

2010

A comparison of policies to limit the transmission of influenza virus from health care workers (HCWs) to patients, Lavanya Amara

Improving Regulatory Processes for Investigator Initiated Studies at the University of Michigan, Debra Krease

Compendium for the Regulation of Nanotechnology: Past, Present and Future, Jessica Knowlton

A sub-analyses from the Benign Prostatic Hyperplasia (BPH) Registry and Patient survey: Predictive validity of the International Prostate Symptom Score (IPSS) in Ethnic Minority-African Americans with Benign Prostatic Hyperplasia (BPH), Fatai Osinowo

Evaluation of the Risks and Benefits of Vaccines in Children, Pranali Wandile

2009

The Protection of Subjects Rights in International Clinical Trials, Olga Muccino

Artificial Cervical Disc Replacement Vs. Anterior Cervical Discectomy and Fusion, Ben Murray

Academic and Professional Status Survey of Current and Former Students of EMU’s Clinical Research Administration program Fall/Winter 2008-2009, James Vitale

2008

Evaluating Current Post-IRB approval practice:  Is it QI/QA, audits or more?, Belinda Adamson

Global Clinical Trials and the Protection of Human Subjects, Christian Buhagiar

A Study of Warning Letters Issued to Institutional Review Boards (IRBs) from the Food and Drug Administration (FDA), Arthi Ramakrishnan

An Investigation of Social Support and Physical Activity as Lifestyle Components of Weight Loss or Maintenance in Michigan’s Overweight Population, Elizabeth Sandusky

2007

Can there be a Global Preparedness for Avian Influenza Preparedness Preparation, Dana Dyderski

Do Radio Frequency Identification Devices have the Potential to Combat Counterfeiting in the Pharmaceutical Industry?, Lydia McGowan

An Overview of Clinical Studies Assessing the Effectiveness of a Multi-Modal Regime for Prevention of Deep Vein Thrombosis Following Total Joint Replacement of the Hip or Knee with a Focus on Mechanical Pneumatic Device Effectiveness, Jan Parslow

A Study of the Effectiveness of Warning Letters in Achieving Voluntary Compliance by Regulated Firms for Product Misbranding Violations in 2005, Christine Tervo

2006

Waiver of Informed Consent for Military Service Members, Dana Jackson

"Primum non nocere" ("First do no harm"), Kathryn Lindblad

Ethical Considerations of Conducting Clinical Research in Developing Countries, Kate McGovren

2005

 A Report on the Comprehensive Database of Academic  Clinical Research Programs in the United States, Donna Harsh

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