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Science & Research

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Current and Previous Intramural Research Science Program Awards

Center for Biologic Evaluation and Research (CBER)

 

2009

Indira Hewlett, Ph.D.

In Vitro Studies to Assess Impact of Gender and Co-Infection with Herpes Simplex Virus Type 2 on the Replication and Transmissibility of Major Emerging HIV-1 Variants

 

Debora Taylor, Ph.D.

The Role of Estrogen in Enhancing Innate Immunity During Viral Infection

 

2008

Mustafa Akkoyunlu Ph.D.
The Role of Vaccine Adjuvant Mediated TACI Upregulation in SLE

 

Andrew Dayton, Ph.D.

Effects of B-Estradiol on the Safety of Anti-HIV Drugs

 

2007
Indira Hewlett, Ph.D.
Evaluation of Gender Differences in Detection, Replication and Transmissibility of Emerging HIV-1 Variants

 

Deborah Taylor, Ph.D.

The Role of Estrogen in Enhancing Innate Immunity During Viral Infection

 

2006

Hana Golding, Ph.D., Surender Khurana, Ph.D.

HIV SELECTEST A Novel Assay for Diagnosis of HIV Infections in the Presence of Antibodies Induced by Candidate HIV Vaccines:  Evaluation of Gender Bias in Sensitivity and Specificity

 

2004

Felice D’Agnillo, Ph.D.                                                                                      

Gender Based Differences in the Vascular Response to Anthrax Toxin: Investigation of the Role of Hormones in an In Vitro Human Endothelial Cell Culture System 

 

Andrew Dayton, Ph.D.                                                                                        

Gender Dimorphism in HIV Infection in Primary Macrophages and T-Lymphocytes  Kinetics of HIV Replication and Efficacy of Anti-Retroviral Agents

 

2002

Daniela Verthelyi, Ph.D.                                                                                        

Effect of Sex Hormones on the Immune Response to CpG ODN

 

2001

Hana Golding, Ph.D., Marina Zaitseva, Ph.D.                                                    

Thymic Regeneration and Immune Function Reconstitution in Babies Born to HIV-infected Mothers

 

1999
Vance Berger, Ph.D.                                                                                              

 Improving the Evaluation of Ovarian Cancer Treatment

 

Carolyn Deal, Ph.D.                                                                                               

Hormone Effects on Pathogenesis & Host Cell Interactions of N. Gonnorrhea

 

1998
Frederick Miller, M.D., Ph.D.                                                                                   

Silicone Gel-filled Breast Implant Capsules:  A Molecular Histologic and Immunophenotypic Study

 

Emily Shachter, Ph.D.                                                                      

Improve the Efficacy of Chemotherapeutic Drugs for the Treatment of Breast Cancer


1997
Margaret Bash, M.D., MPH                                                               

Antigenic Characteristics and Immunogenicity of Synthetic Peptide Vaccines for the Pathogenic Neisseria: Neisseria meningitides and Neisseria gonorrhea

 

Hana Golding, Ph.D.                                                                        

Sexual transmission of HIV-1 in Women and Mother to Infant Transmission: The Importance of HIV-1 Co-receptor Expression on Cerviovaginal Cells and on Cord Blood Cell Subsets

 

1996
Dennis Klinman, M.D., Ph.D.

A Novel Approach to the Treatment of Lupus Nephritis                                     

 

Penelope Robbins, Ph.D.                                                                            

Human Cytotoxic T Lymphocyte Recognition of Papilloma Virus

 

Emily B. Shachter, Ph.D.                                                                                 

Administration of Thrombolytic Therapy to Women with Acute Myocardial Infarction: Is It Too Late?

 

Giovanna Tosato, M.D.                                                                  

IP-10: A Potential New Therapeutic for Breast Cancer

 

1995
David S. Finbloom, M.D.                                                                             

Cytokine Induced Activation of the Jak Kinase/STAT Transcription Factor Pathway in Immune Cells (Monocytes and Lymphocytes) of Patients with Rheumatoid Arthritis and Systemic Lupus Erythematosus

 

Basil Golding, M.D.                                                                                          

Induction of Mucosal Immunity to Protect Females from HIV-1

 

Dennis Klinman, M.D., Ph.D.                                                                               

Hormonal Regulation of Cytokine-producing Cells in Women with Systemic Lupus Erythematosus

 

Philip R. Krause, M.D.                                                                   

Development of a Method to Evaluate the Effect of Vaccines and Antiviral Therapy on Latent Viral Burden in an Animal Model of Genital Herpes

 

Carol B. Trapnell, M.D.                                                                                     

The Effect of Thalidomide on the Pharmacokinetics of Ethinyl Estradiol and Norethindrone

 

1994
Frederick W. Miller, M.D., Ph.D.                                                               

Immunogenetic Risk Factors for Silicone-associated Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance

 

Michael A. Norcross, M.D.                                                                                     

Women and AIDS Transmission

 

Carol B. Trapnell, M.D.                                                                                     

An Open-label, Randomized, Cross-over, Feasibility Study to Quantify the Retention of Vaginally Administered Nonoxynol-9 (N-9) Foam in Premenopausal Women


Center for Drug Evaluation and Research (CDER)

2009

Luis Valerio, Jr., Ph.D.

Computational Human Health Effects Study to Assess the Safety of Botanical Extracts Widely Used by Women in the United States for Treatment of Menopausal Symptoms

 

Karen Feibus, M.D.

Ethics Roundtable:  The Ethics of Studying Drugs and Biologics in Pregnant Women

 

2008

Christine Garnett, Ph.D., Philip Dinh, Ph.D.

Gender-Related Differences in QT Effects and Torsade de Pointes Potential of Drugs

 

Christy John, Ph.D.
Qualifying Imaging Biomarkers to Monitor Neoadjuvant Chemotherapy in Breast Cancer Patients to Identify Responders Using Positron Emission Tomography (PET)

 

Sandra Kweder, M.D., Susan Cummins, M.D.

The Athma and Allergy Medications in Pregnancy Surveillance System (AAMPSS) Demonstration Project

 

Nakissa Sadrieh, Ph.D.

Evaluating the Effects of Over-the-Counter Skin Products, such as Sunscreen, on the Absorption of Dermally Applied Estradiol, in an In- Vitro and an In-Vivo Model

 

Anna Szarfman, Ph.D.

Detection and Confirmation of Gender Related Safety Signals Using the Electronic Healthcare Data from the Department of Defense

 

Lee Zhang Ph.D.

Safer use of Narcotics in Pregnant and Lactating Women

 

2007

Shashi Amur, Ph.D

Gender, Ethnicity and Pharmacogenomics in Systemic Lupus Erythematosus (SLE)

 

Audrey Gassman, M.D.

Workshop: Drugs in Pregnancy

 

Yongsheng Yang, Ph.D.

Identification of Sex Differences in Adverse Outcomes for New Molecular Entities (NMEs) Approved from 2000-2002

 

2006

Shashi Amur, Ph.D.

Gender Differences and Impact of Pharmacogenomics in Rheumatoid Arthritis

 

Angela Men, Ph.D., Shashi Amur, Ph.D.

Impact of Gender Analysis and Pharmacogenomics on Clinical Efficacy, Safety, and Pharmacokinetics of Drugs Used for the Treatment of Alzheimer’s Disease.

 

Roshni Ramchandani Ph.D., Edwin P. Rock, M.D., Ph.D.
Quantitative Tumor Size- Survival Relationship in Oncology Clinical Trials

Ohidul Siddiqui, Ph.D.
Statistical Analysis of Gender Specific Data from New Drug Application (NDA) Submissions

 

Greg Soon, Ph.D.

Women in HIV Trials: A Comprehensive Review and Meta-Analysis

 

Mary Willy, Ph.D.
Drug Use in Pregnancy

 

Yongsheng Yang, Ph.D.

Participation of Women in Clinical Trials and Gender Analysis of Data in Original NDAs Approved 2000-2002.

 

2005

Hyojong Kwon, Ph.D., Robert Lionberger, Ph.D.                                  

Sex Difference Dependent Drug-drug Interactions of Anti-HIV Therapeutics


2004

Ellen Tabak, Ph.D, Leslie Wheelock, Ph.D.                                                

Gender Differences in the Willingness to Read and Follow Patient Information


2003

Jogarao Gobburu, Ph.D.                                                                                    

Are Women at Higher Risk from Proarrhythmic Drugs?

 

Eugene Herman, Ph.D.                                                                                   

Discovery and Evaluation of Interspecies Biomarkers to Monitor the Early Onset and the Progression of Cardiovascular Toxicity Associated with Tiazolidinedione Compounds Used in the Treatment of Type 2 Diabetes

 

John. Koerner, Ph.D.                                                                                        

Electrophysiological Characterization of Several Torsadogenic Drugs in Isolated Rabbit Hearts

 

2002

Mei Ling Chen, Ph.D.                                                                                                  

Gender Effect on the Assessment of Bioavailability and Bioequivalence Gender Differences in Intestinal Levels of CYP3A4, CYP 3A5, P-gP and MRP

 

2001

Eugene A. Herman, Ph.D., Frank Sistare Ph.D.                                                           

Discovery and Evaluation of Interspecies Biomarkers to Identify and Characterize the Cardiotoxic Effects of Herceptin, a Novel Antibody Used in the Treatment of Breast Cancer

 

Shew-Mei Huang, Ph.D., Steven Hall Ph.D.                                                                

The Effects of Echinacea on Cytochrome P450 Enzymes and Oral Contraceptives

 

Shinya Ito, M.D., Gerald Fetterly, Ph.D.                                                             

Drug Update in Human Mammary Gland Epithelia

 

Patrick J. McNamara, Ph.D., Gerald Fetterly, Ph.D                                             

Development of a General Approach for the Investigation of Drug Transfer in Breast Milk: In Vitro Assessment of Drug Distribution into Breast Milk


2000
Debra Birnkrant, M.D., Ajaz Hussain, Ph.D.                                                    

Vaginal Volume: Optimizing Vaginal Deployment of Topical Microbicides

 

Ann Farrell, M.D., Lilia Talarico, M.D.                                                            

Women's Participation in Clinical Drug Trials for Unstable Angina and Myocardial Infarction

 

Ronald Honchel, Ph.D., Frank Sistare, Ph.D.                                                     

Evaluation of the Tg.AC Transgenic Mouse as a Model for Predicting the Photocarcinogenicity of Pharmaceuticals and Cosmeceuticals

 

1999

Chandra Sahajwalla, Ph.D.                                                                                 

Evaluation of In-vitro Mechanistic Basis for Gender Dependant Differences in Pharmacokinetics

Mary Willy, Ph.D.                                                                                             

Post-marketing Drug Risk Assessment Using the ARAMIS Database in RA Patients

 

1998
Kathryn Aiken, Ph.D.

Pregnancy Labeling Taskforce Focus Group testing (co-funded by NIH ORWH)

 

Shiew Mei Huang, Ph.D., Robert Branch, Ph.D.                                                

Gender Differences in P450 Activities and their Implications (co-funded by NIH ORWH)

 

Thomas Layloff, Ph.D.                                                                                                   

Chemical Characteristics of Conjugated Estrogens

 

Ralph Lillie, RPh                                                                                               

Adverse Events Reporting System (AERS):  Risk assessment, Compliance & Management

 

Carolyn McCloskey, M.D., MPH

Teratogen Surveillance

 

Ana Szarfman, M.D., Ph.D.                                                                                

Data Mining Techniques for Identifying Potential Serious Drug Interactions in Women

 

Ana Szarfman, M.D., Ph.D., Raymond L. Woosley, M.D., Ph.D.            

Variations in the Drug-induced QT Interval Prolongation During the Menstrual Cycle (Co-funded by NIH ORWH)

 

1997
John Strong, Ph.D.                                                                                            

Contribution of Estrogen Components to the Efficacy of Conjugated Estrogens - Preliminary

Analytical Chemistry

 

Ana Szarfman, M.D., Ph.D.                                                                                

Visualization Tools for Studying Gender Differences

 

1996
Donna A. Volpe, Ph.D.                                                                                       

In Vitro Prediction of Time to Neutropenic Nadir: Anti-neoplastic Alkylating Agents as Prototype Drugs

 

1995

Edwin J. Matthews, Ph.D. 
Estimation of Reproductive Toxicity of Pharmaceuticals Using QSAR Software Programs


Bruce V. Stadel, M.D.                                                                                              

Hormone Replacement Therapy in Women with a Previous Diagnosis of Endometrial Cancer

 

Ellen R. Tabak, Ph.D.                                                                                           

Gender Differences in Perception of Risks Communicated by Prescription and Over-the-counter Drug Labels, Phase I and II

 

Brenda Vaughan, M.D.                                                                                          

Thalidomide: Are There Gender Disparities in Treatment Outcome and Non-teratogenic Adverse Effects?

 

Sheila Weiss, Ph.D.                                                                                               

Profile of Drug Use in Pregnancy

 

1994
Lou Cantillina, M.D.                                                                                

Women in Clinical Trials Terfenadine/Oral Contraceptive Study                  


David Flockhart, M.D., Ph.D.                                                                  

Comparison of the Beta-adrenergic Antagonist Actions of Propranolol in Men and Women


Raymond L. Woosley, M.D., Ph.D.                                                         

Comparison of the Potassium Channel Blocking Actions of Quinidine in Men and Women

 

 

Center for Device and Radiological Health (CDRH)

 

2009

Srinidhi Nagaraja, Ph.D., Maureen Upton, Ph.D.

Do Vertebroplasty Procedures Increase the Risk of Adjacent Level Vertebral Fractures in Osteoporotic Women

 

Kathryn O’Callaghan, B.S.

Analysis of Sex-Differences in Cardiac Resynchronization Therapy Devices:  Inclusion, Adverse Events, and Outcomes

 

Peter Goering, Ph.D., Kevin McBryde, M.D.

Development of Urinary and Serum Biomarkers of Kidney Damage in Patients with Systemic Lupus Erthematosus Nephritis

 

Dinesh Patwardhan, Ph.D.

Sex-Based Differences in the Safety of Drug-Eluting Stents Containing Bioresorbable Materials

 

Aldo Badano, Ph.D.

Development of a Tissue-Mimicking Physical Phantom and Quantitative, Assessment Toos for Standardizations, Optimization, and NSF Risk Reduction in Dynamic Contrast-Enhanced MRI of the Breast

 

Iacovos Kyprianou, Ph.D.

Women’s Radiation dose and Excess Cancer Risk Associated with X-Ray Computed Tomography Scans:  Quantification and Risk-Mitigation Strategies

 

2008

Kish Chakrabarti, Ph.D.

Dose and Image Quality Optimization in Full Field Digital Mammography

 

Bedri Karakas, Ph.D.

A Safe and Sensitive Assay to Evaluate Response and  Relapse using DNA Mutation Biomarkers and Bead  Based Emulsion PCR in Women with Breast Cancer

 

Cara Krulewitch, CNM, Ph.D.

The Safety and Effectiveness of Surgical Mesh Implant Use in Uro-Gynecologic Surgery for Soft Tissue Augmentation

 

Kathryn M. O’Callaghan, B.S.

Workshop: Guidance for the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Devices

 

Subok Park, Ph.D.

Patient Safety and Imaging Performance of Three-Dimensional (3D) X-Rays Systems for Detection of Breast Cancer

 

Cunlin Wang, M.D., Ph.D.

Gender Differential in National Estimates for Medical Device-Associated Adverse Events (MDAEs) from Emergency Departments

 

2007

Soma Kalb, Ph.D.

Factors Accelerating the Progression of Heart Failure (HF) in Women: Implications for Drug Interactions with Medical Devices

 

Dinesh Patwardhan, Ph.D.

The Impact of Sex-Based Differences in Atherosclerotic Plaque on the Response to Drug Eluting Stent Implantation

 

Art Sedrakyan, MD, PhD

Real-World Outcomes of Drug-Eluting Stents

 

2006

Jove Graham, Ph.D.

Evaluating the Effectiveness of Vertebroplasty for Improving the Mechanical Properties of the Spine in Patients with Osteoporosis.

 

Kathryn O’Callaghan B.S.

Evaluation of Availability and Quality of Information Available on Females Included in Mechanical Device Implant Trials.

 

2005

Iacovos Kyprianou, Ph.D., Kyle Myers, Ph.D.                                     

Implications of Gender-based Differences in Cardiovascular Disease on Imaging for Treatment and Diagnosis

 

Azadeh Shoaibi, M.S., MPH, Dale Tavris M.D. MPH                                                     

Assessment of the Accuracy of the Troponin Assay and the Diagnosis of Myocardial Infarction by Gender/ How Gender Influences Treatment

 

2004

Jove Graham, Ph.D.                                                                                     

Development of Guidelines for Evaluating the Appropriateness of Vertebroplasty Surgery for Patients with Osteoporosis

 

2003

Melvin Stratmeyer, Ph.D.                                                                            

Cardiovascular Effects of Ultrasound Contrast Agents in Intact and Ovariectomized Female Animals

 

2002

Dale Tavris, M.D.  MPH                                                                                            

Incidence and Attributable Risk of Serious Adverse Events and Death Associated with the Use of Homeostasis Devices by Gender

 

2001

Rosalie Elespuru, Ph.D., Roselie Bright, Sc.D.                                           

Developing a Diagnostic Gene Expression Profile for Latex Sensitivity Using Microarrays

 

Sharon Miller M.S., Janusz Beer, Ph.D.                                                           

Optimization of UV Exposure Patterns Maximizing Perceived Benefits While Minimizing Photocarcinogenic/photo-aging Effects

 

2000
Ronald Kaczmarek, M.D.                                                                             

Surveillance of Sex-specific Utilization, Morbidity, and Mortality Associated with Transmyocardial Revascularization

 

Richard Kotz, Ph.D.                                                                                                      

A Study to Evaluate the Consistency of T-scores Among Ultrasound Bone Measurement Devices and the Usefulness of these Devices for Monitoring Bone Status

 

1999
Rosalie Bright, Sc.D.                                                                                  

Active Postmarketing Surveillance Methods: A Hospital Pilot

 

Robert Navario, Ph.D, S.L.Brown, M.D.                                                        

Assessment of Consumer Understanding of Barrier Contraception and Tampon Labeling: Focus Group Studies

 

1998

Patricia Dubill, Ph.D.

Abrasion Testing of Breast Implants

 

James Karanian, Ph.D.                                                                                

Ovarian Steroids and Cardiovascular Disease  the Role of Gender in the Effectiveness of Interventional Medical Devices

 

Harvey Rudolph, Ph.D.                                                                             

Accelerated Aging Studies of Condoms/condom Materials

 

Harvey Rudolph, Ph.D.                                                                                

Flow Studies and the Use of a Waveguide in Cardiovascular Devices

 

Keith Wear, Ph.D.

Development and Validation of Ultrasonic Backscatter Measurement for Bone Density Assessment

 

1997
S. Lori Brown M.D.,
Institute of Medicine Study: A Study of Safety of Silicone Breast Implants                                                                            

 

S. Lori Brown, M.D.                                                                                           

Protocol for a Study of Breast implant rupture

 

Rosalie Bright, Sc.D.

Mammography Breast Cancer Screening Rates Among Disadvantaged Women within a Pre-Paid Health Care System

 

Robert Jennings, Ph.D.                                                                            

Optimization of mammography

 

Steven Lascher, DVM, MPH                                                                     

A Comparison of Gender Specific Utilization of Implantable Cardioverter Defibrillator Therapy and Post-implantation Survivability

 

Danica Marinac-Dabic, M.D.                                                                     

Epidemiology of Medical Devices in Women (conference)


1996
Marwood N. Ediger, Ph.D.                                                                              

Development of a Safe, Economical Assay for Silicone Containment in Blood and Tissue

 

Melvyn Greberman, M.D., MPH                                                                        

The Transfer of Defense, Intelligence and Space Technologies for the Early Detection and Control of Cancers in Women (conference)

 

Matthew R. Myers, Ph.D.                                                                                 

A Computer Model for Simulating Virus Transport through Barriers

 

1995
Danica Marinac-Dabic, M.D.                                                                         

Gender Differences in Early and Long-term Results of Coronary Angioplasty with Palmaz/Schatz Stent

 

Kyle Myers, Ph.D.                                                                                              

Non-invasive Assessment of Silicone Migration from Gel-filled Breast Implants

 

Paula G. Silberberg, M.D.                                                                                 

Contraceptive Efficacy Table for Uniform Contraceptive Labeling-- a Consumer Focus Group Study - Part I and II

 

Keith A. Wear, Ph.D.                                                                                       

Application of Ultrasonic Tissue Characterization to Diagnosis of Bone Disease

 

1994
John Langone, Ph.D.                                                                                         

Silicone Gel Alternatives Workshop

 

Carol Sierka, B.S.                                                                                                   

Consumer Brochure on Mammography

Development of MQSA Speaker Kits


Center for Food Safety and Nutrition (CFSAN) 

 

2008

Thomas Flynn, Ph.D.

Evaluation of Inflammation and Sex Hormones as Biological Factors that May Contribute to Gender Differences in Susceptibility to Chemical-Induced Liver Injury – Studies Using Human Liver Cells in Culture

 

2007

Elizabeth Calvey Ph.D., Marjorie Davidson, Ph.D.

Understanding Consumer Behavior Associated with Changing Messages on Listeria monocytogenes and Food Safety

 

2004

Maria Lorenzo, DVM, Mona S. Calvo, Ph.D., Dennis Hinton, Ph.D. Susan B. Harper,

Sabine Francke-Carroll, and Rene K. O’Neill                           

Do Phytoestrogens Modify the Allergic Response to Food Allergens in the Newly Validated, Highly Sensitive, In-Bred Asthmatic Rat Model

 

Robert Sprando, Ph.D.                                                                                            
Developmental Toxicity of Androstenedione in Rats

 

2002

Robert Sprando, Ph.D.                                                                                       

Characterization of the Effect of Pre-pubertal and Pubertal Exposure of Androstenedione on Female Reproductive Health

 

2000
Jeffrey Yourick, Ph.D.                                                                              

Teratogenic Potential of Cosmetic Products Containing Retinol (Vitamin A) and Retinyl Palmitate-Phase I

 

1999
Robert Bronaugh, Ph.D.                                                                                   

Potential Exposure of Women to Estrogens, Phytoestrogens and Xenoestrogens through Cosmetic Products

1998
Kenneth T. Durham, Ph.D.

CFSAN's Internet Initiative: Infra-structure Support

 

Nancy Slifman, M.D., MPH                                                                   

Contaminants in Dietary Supplements Frequently Used in Women

 

1997
Shirley R. Blakely, Ph.D.                                                                        

Obesity: Its Effect on Antioxidant and Estrogen Metabolism

 

Mona S. Calvo, Ph.D.                                                                             

Vitamin K Status of Non-Hispanic Black and White Girls and Young Adult Women: Direct Measure of Serum Phylloquinone Levels and Measurement of a New Functional Endpoint in Serum Samples from NHANES III

 

1996
Kenneth T. Durham, Ph.D.                                                                                 

CFSAN's Women's Health Internet Initiative- Phase II

 

Thomas J. Sobotka, Ph.D.                                                                       

Screening for Nervous System Dysfunction in Offspring of Dams Exposed to Natural Food Contaminates During Pregnancy

 

Ruth A. Welch, Ph.D.                                                                                       

Women's Health Information Line

 

1995
Kenneth T. Durham, Ph.D.                                                                                 

CFSAN's Women's Health Internet Initiative - Phase I

 

Mary L. Tortorello, Ph.D.                                                                        

Rapid Method for Detection and Enumeration of Listeria Monocytogenes in Foods

 

Ruth Welch Ph.D., Carole Schiffman Ph.D.                                                           

Osteoporosis Prevention in Adolescent Girls

 

1994
John E. Bailey, Ph.D.                                                                                       

Cosmetics Initiatives Alpha Hydroxy Acids (AHAs)


John E. Bailey, Ph.D.
AHA Literature Search

 

Sara B. Fein, Ph.D.                                                                                   

Infant Feeding Practices Study


Center for Veterinary Medicine (CVM)


2000

Jurgen von Bredow, Ph.D.

Use of a Unique Animal Model to Study Placental Milk Transfer of Ciprofloxicin from the Dam to the Offspring During the Perinatal Period

 

1995
John Leighton, Ph.D.                                                                                             

A Novel Molecular Approach to Risk Assessment of Hormonally Active Compounds


National Center for Toxicological Research (NCTR)

 

2009

Mark Hart, Ph.D.

Application of Co-Culture and Simulated Vaginal Models to Elucidate in the Inhibitory Properties of Naturally Occurring and Bioengineered Strains of Lactobacillus Toward Toxic Shock Syndrome Toxin-1 Producing Strains of Staphylococcus Aureus

 

Weida Tong, Ph.D.

Development of an FDA Resource for Sex Difference-Related Pharmacogenomics data Review-Phase II

 

Beverly Lyn-Cook, Ph.D.

Women’s Health Initiative Seminar Series and Workshop at NCTR

 

Beverly Lyn-Cook, Ph.D., Athena Starland-Davenport, Ph.D.

Inactivation of UDP-Glucuronosyltransferases (UGTs) in Human Breast and Endometrial Tissues:  Accessing Cancer Risk, Tamoxifen Safety and Toxicity

 

2008

Huizhong Chen, Ph.D.

Risk Assessment of Human Skin Microflora Metabolism of Synthetic Azo Colorants used in Women’s Cosmetics

 

Beverly Lyn-Cook, Ph.D.

Genotyping of  Transporter Genes Associated with Gender Differences and Promoter Methylation Profile of UGT1A1 in Human Liver: A Mean of Assessing Safety and Toxicity of Chemotherapeutic Drugs

 

Doug Wagner, Ph.D.

Gene Expression Responses of Estrogen-Primed Vaginal Epithelial Cells After Contact With Candida albicans and Probiotic Lactobacilli


2007

Beverly Lyn-Cook, Ph.D., Neera Gopee, Ph.D.

Sex differences in Systemic Lupus Erythematosus (SLE):  Effects of a single nucleotide polymorphism (SNP) in the prolactin (PRL) gene on individual response to prasterone therapy

 

Baitang Ning, Ph.D.

Mechanisms of Gender Differences in Aspirin Effects:
Metabolizing Enzymes and Therapeutic Targets

 

Weida Tong, Ph.D.

Development of a FDA Resource for Improved Efficiency of Sex Difference Related Pharmacogenomic Data Analysis and review

 

2006

Varsha Desai, Ph.D.
Molecular Mechanisms Underlying Gender-associated Differences in the Adverse Reactions to the Anti-retroviral Agent, Zidovudine (AZT)  Role of Mitochondrial Toxicity

 

Christopher Elkins, Ph.D., Mark Hart, Ph.D.
Protective Effect of Vaginal Lactobacillus Species Against Staphylococcus Aureus-mediated Toxic Shock Syndrome

 

Beverly Lyn-Cook, Ph.D.
Sex Differences in Chemotherapeutic Toxicity: Profiling of Transporter Genes in Human Liver

 

2005

James Fuscoe, Ph.D.                                

Systems Biology Approach to Evaluate Sex Differences in the Heart of a Rat Model

 

2002

Angela Harris, Ph.D.                                    

Development and Characterization of Conditionally Immortalized Human Primary Hepatocyte Cell Lines From Female And Male Donors -- Phase I

 

2000
Anane Aidoo, Ph.D.                                   

Evaluation of the Effects of Daidzein And Genistein on The Genotoxic and Carcinogenic Activity of the Model Mammary Carcinogen 7,12-Dimethylbenz(A) Anthracene (DBMA) in Ovariectomized Transgenic Big Blue Rats

 

Vasily Dobrolovsky, Ph.D.             

Evaluation of the Tk Knockout Mouse as a Model of Systemic Lupus Erythematosus

 

1999
Dean Roberts, Ph.D.                                  
Antigenic Biomarkers of Estrogen Catechol Metabolism for Post-Market Surveillance of Oral Contraceptives and HRT's

 

1998
Patricia Thompson, Ph.D.                         

In-Vivo Modeling Of Steroid-Mediated Gender Effects in Drug Metabolism (Phase I and II)

 

1997
Christine B. Ambrosone, Ph.D.                

Breast Cancer in African-American Women: Metabolic Modification of Dietary and Hormonal Risk Factors

 

S. Jill James, Ph.D.
Molecular and Metabolic Determinants of Maternal Risk and Progression of Down's Syndrome  Potential for Nutritional Intervention

 

William H. Tolleson, Ph.D.                        

Development Of In Vitro Human Cell Culture Systems to Screen Compounds Suspected To Have Estrogenic or Anti-Estrogen Activity

 

1996
Frederick A. Beland, Ph.D.                                   

DNA Adducts of Tamoxifen

 

Darnell Carlton Jackson, Ph.D.               

Development of an Estrogen Knowledge Base for Research and Regulation

 

Daniel M. Sheehan, Ph.D.                        

Experimental Assessment of Environmental Estrogens

 

1995
S. Jill James, Ph.D.            

Mechanism of Immunotoxicity and Carcinogenicity Associated With Silicone Breast Implants

 

Randal Streck, Ph.D.                                 

Mechanism of Tamoxifen Development Toxicity and Neoplasia Tamoxifen Effects on the Rat Uterine Insulin Like Growth Factor System

 

1994
Dan Sheehan, Ph.D.                     

Effects of Toremifene and ICI 182,780 on Rat Uterine Growth


Office of External Affairs (OEA)

 

1995

Peter Rheinstein, M.D., JD                                                                          

Research Involving Human Subject Committee (RIHSC)

 

Teresa Toigo, RPh, MBA                                                                       

Development and Expansion of a Pilot Tracking System for Monitoring the Barriers to the Enrollment of Women in Clinical Trials

 

1994
Conference on STD Clinical Trials Workshop (NIH and OEA)
April 6-8 1994                                             

 

Office of Regulatory Affairs (ORA)

 

2007

Lesley Kerr, Ph.D.,

Development of a Rapid Version of the Tampon Test Method Based on 21CFR801.430

 

Phyllis Wilson, Ph.D.,

Development and Validation of an HPLC Method for the Simultaneous Determination of Estradiol, Estriol, Estrone and Progesterone in Pharmaceutical Preparations

 

2000                                                                                                                 

Jeffery Archer, M.S.

Analysis of Dioxins/Furnas (17 congeners) Levels in Tampons

 

1998

Lesley Kerr, Ph.D.                                                                                                       

Development and Validation of a Universal Water Leak Test Method for Barrier Contraceptives

 

1995

Barbara Ward-Groves, MPH                                                                          
Mammography Quality Standards Act Facilities Workshop


Office of the Commissioner (OC)

 

2008

Steven Tucker, Ph.D,

Effects of Proposed Revisions to the Regulations Implementing the Mammography Quality Standards Act

 

2007

Lonnie Smith

SPL XML Tagging

 

1994

OWH Small Grants Program

Workshop: FDA-regulated Products and Pregnant Women

    
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