2020
- Rate of Termination in Clinical Depression Trials [PDF], Sai Priya Marrapu
- Warning Letters Issued to Sponsors, IRBs and Investigators from 2010 to 2019 [PDF],Deepika Sri Prashanthi Gundrathi
- Does Adverse Event Reporting by Consumers Via Social/Online Media Platforms Impact the Drug Safety Profile? [PDF],Jaspreet Singh
- Evaluation of Class I Solid Oral Drug recalls: Can such Recalls be Preventable? [PDF], Navya Chiramana
2019
- "Drug Lag” Analysis of Monoclonal Antibodies in the United States and Europe [PDF], Vibha Sharma
- Comparison in Oncological Indication Approval Policies between the United States and Europe [PDF], Nitesh Tirumala
- Changes in the Rate of FDA Warning Letters and Untitled Letters Issued by CDER’s OPDP [PDF], Fatima Jawed
- Investigating Safety Signals: Non-Prescription Retinoids versus Prescription Tretinoin [PDF], Margaret M. Whitton
- Label Readability Analysis of FDA Regulated OTC Drug Products and Cosmetics [PDF], Keerthi Pakeer
2018
- An Analysis of Differential Acceptance Rates of Advisory Committee Recommendations by FDA Review Divisions Within CDER [PDF], Pallavi Neeraj
- FDA’s Accelerated Approval Process: Efficacy Assessment of Surrogate Endpoints And Post-Marketing Studies [PDF], Saikavya Bekal Rao
- 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 [PDF], Nicholas Hill
- The Effectiveness of Eastern Michigan University’s Institutional Review Board [PDF], DeQuindalyn D. Moore
- Use of Nonsteroidal Anti-Inflammatory Agents and Risk of Melanoma and Non-Melanoma Skin Cancer [PDF], Santhosh Reddy Mukkisa
2017
- The Effect of Shorter Review Times on Drug Safety Information [PDF], Dawud Ellayan
- An Evaluation of the Readability of Drug Trials Snapshots[PDF], Sharada Lanka
- Clinical Trials in India: History, Current Regulations, and Future Considerations [PDF], Kalindi Naik
- Effects of FDA Imposed Pediatric Initiatives since 1997; Expectations vs Actualizations[PDF], 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[PDF], Dhirenvijaykumar Aaytee
- An analysis of trends in drug advertising violations based on Warning letters & Untitled letters issued by the US FDA[PDF], Chavan Chetanshaligram
- “Drug Lag” analysis of New Molecular Entities between the United States and Europe [PDF], Vivekdasharath Deore
- Evaluation of Factors Associated with Human Papilloma Virus [HPV] Vaccine Acceptability in Parents of Adolescents[PDF], Sravankumar Goli
- Are the Strategies Taken by the FDA Effective in Combating Counterfeit Drugs?[PDF], Rakesh Padigala
2015
- A Case Study of Serious Adverse Event Reporting: Chantix[PDF], Zainab Jafar
- An Analysis of Factors in the Approval of Orphan Drugs for the Rarest Diseases[PDF], Sadeepa Munasinghe
- Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical Trials[PDF], April M. Nelson
- Comparison of the Dietary Supplements Use in the U.S. And Developing Countries: 2003–2015 [PDF], Nutandeepthi Ponnada
- Correlation between General Population Suicide Rates and NIH Funding in the United States[PDF], Noel B. Ramsey
- Eastern Michigan University Human Subjects Review Committee: Analysis of Review Times[PDF], Mrunmayee Samant
- Cyclical Health Patterns in Alzheimer’s Patients and Caregivers[PDF], Christopher Schneider
2014
- US vs. Foreign Source of Counterfeit Drugs Found in US[PDF], Sruthi Akavaram
- Analysis of FDA Safety Alerts from 2003 to 2012[PDF], Sruthi Akavaram
- Does Priority Review Result in a Higher Frequency of Drug Withdrawals From the Market Than Standard Review[PDF], Apoorva Gudimella
- Long-term Use of Autologous Serum Eye Drops for the Treatment of Dry Eye Disease [PDF], Munira T. Hussain
- Relationship Between Cancer Incidence, Mortality Rates and Funding [PDF], Sowmya Mallela
- Deviations from Ethical Drug Promotion in India[PDF], Srilakshmi Medavarapu
- Analysis of the impact of FDA labeling revisions: The Fentora case study [PDF], Gopal Reddy Palvatla
- Protection of Subjects and Regulation of Clinical Trials in India[PDF], Deepthi Pandiri
- Review of Warning Letters Issued to Clinical Investigators During The Years 2002 to 2011[PDF], Pratyusha Bedadala
- Cost Comparison of Medical Treatment in the United States vs India for Uninsured Americans[PDF], Jahnavi Vellanki
- Percentage of Non-Caucasians in Clinical Trials from 2000 to 2009[PDF], 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[PDF], Nikhila Devireddy
- Do the Differences in Worldwide Labeling for Some Drugs Correlate with Known Metabolic Variations in Different Races?[PDF], Girish Kankipati
- Regulatory Challenges in the Manufacturing, Adverse Event Reporting and Marketing of Combination Products[PDF], 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[PDF], Uday K Singathi
- Comparison of Prescription Procedures between Developed Countries and India- Suggestions on How to Minimize the Prescription Errors in India[PDF], Sandeep Kumar Thudi
- Regulatory Issues with Current Dietary Supplement Regulations in the U.S.: Have Politics Triumphed over Science?[PDF], Soujanya Vidiyala
2012
- Can the Reasons for Class-I Device Recall Be Predicted Prior to Regulatory Approval?[PDF], 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[PDF], 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[PDF], 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?[PDF], 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[PDF], 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 [PDF], 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)[PDF], 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[PDF], 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[PDF], Dana Jackson
- "Primum non nocere" ["First do no harm"][PDF], Kathryn Lindblad
- Ethical Considerations of Conducting Clinical Research in Developing Countries[PDF], Kate McGovren
2005
- A Report on the Comprehensive Database of Academic Clinical Research Programs in the United States, Donna Harsh
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