Selected Publications and Presentations
- Jean T. Barbey
Barbey JT, Lazzara R, and Zipes D. "Spontaneous Adverse Event Reports of Serious Ventricular Arrhythmias, QT prolongation, Syncope, and Sudden Death in Patients Treated with Cisapride." J Cardiovasc Pharmacol Therapeut, 7(2):65-76, 2002.
Williams G, Dunnington K, Ming-Yi H, Zimmerman T, Zhiming W, Hafner K, Stolz M, Hill E, and Barbey JT. "The Impact of Posture on Cardiac Repolarization: More than Heart Rate?" J Cardiovasc Electrophysiology 2006 17 (4) 352-358, 2006.
Barbey JT, Pezzullo JC, and Soignet SL. "Effect of Arsenic Trioxide on QT Interval in Patients with Advanced Malignancies." J Clin Oncol 21: 3609-3615, 2003.
- Kenneth White
Technology Book Chapters
White K in Avery J and Holmes J, eds. Windows Developer Power Tools. Software Lifecycle Tools: Tracking Bugs with CodeTrack. O’Reilly Media, 2006.
Conference Presentations
White K. Regulatory Considerations in Clinical Trial Management System Validation. OpenClinica European Summit, Brussels, Belgium, 2009.
White K. Human Factors in Web-Based Systems. 10th Annual Computer Validation and 3rd Annual IT Conference: “Validation Requirements in Predicate Rules and IT Challenges and Opportunities.” Drug Information Association, 2005.
Peer-Reviewed Journal Articles
Ducci F, Enoch MA, Yuan Q, Shen PH, White K, Hodgkinson C, Albaugh B, Virkkunen M, and Goldman D. “HTR3B is associated with alcoholism with antisocial behavior and alpha EEG power - an intermediate phenotype for alcoholism and co-morbid behaviors.” Alcohol 43(1):73-84. Elsevier: New York, 2009.
Enoch MA, Shen PH, Ducci F, Yuan Q, Liu J, White K, Albaugh B, Hodgkinson C, and Goldman D. "Common Genetic Origins for EEG, Alcoholism, and Anxiety: The Role of CRH-BP." PLOS One, 3(10): 1-11. 2008.
Enoch MA, White K, Waheed J, and Goldman D. “Neurophysiological and Genetic Distinctions Between Pure and Comorbid Anxiety Disorders.” Anxiety and Depression 0:1-10. Wiley: New York, 2007.
Winterer G, Enoch MA, White K, Saylan M, Coppola R, and Goldman D. “EEG Phenotype in Alcoholism: Increased Coherence in the Depressive Subtype.” Acta Psychiatrica Scandinavica 108:51-60, 2003.
Enoch MA, White K, Harris CR, Rohrbaugh JW, and Goldman D. “The Relationship Between Two Intermediate Phenotypes for Alcoholism: Low Voltage Alpha EEG and Low P300 ERP Amplitude.” Journal of Studies in Alcoholism 63(5):509–17, 2002.
Enoch MA, White K, Harris CR, Rohrbaugh JW, and Goldman D. “Alcohol Use Disorders and Anxiety Disorders: Relation to the P300 Event-Related Potential.” Alcoholism: Clinical and Experimental Research 25: 1293–1300, 2001.
- Hilda Maibach
Baraniuk JN and Maibach H. "A Chronic Fatigue Syndrome Severity Score Based on the Minor Criteria for Case Designation and Independent of Fatigue." In process.
Nguyen SH, Dang TP, MacPherson C, Maibach H, and Maibach HI. "Prevalence of patch test results from 1970 to 2002 in a multi-centre population in North America (NACDG)." Contact Dermatitis. 58(2):101-6, Feb 2008.
Baraniuk JN and Maibach H. "Pathophysiological classification of chronic rhinosinusitis." Respir Res. 6:149, Dec 2005.
Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, and Hess SS. "A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid." BMC Neurol. 5:22, Dec 2005.
- Naji Younes
Lachin JM and Younes N. "A composite design for transition from a preliminary to a full-scale study." Stat in Med 26(27):5014-32, 2007.
Hsue P, McManus D, Selby V, Ren X, Pillutla P, Younes N, Goldschlager N, and Waters D. "Cardiac Arrest in Patients Who Smoke Crack Cocaine." Am J Cardiol. 99 (6):822-4, Mar 2007.
Sparling HS, Younes N, Lachin J, and Bautista OM. "Parametric survival models for interval censored data with time-dependent covariates." Biostatistics 7(4):599-614, 2006.
Hsue PY, Kamini G, Erickson S, MacGregor JS, Younes N, Amandeep S, and Waters DD. "Clinical Features of Acute Coronary Syndromes in Patients With Human Immunodeficiency Virus Infection." Circulation 109:316, 2004.
Robouch P, Younes N, and Vermaercke P. The "Naji Plot", a simple graphical tool for the evaluation of inter-laboratory comparisons. PTB-IT-10: 149, ISSN 0942-1785, ISBN 3-89701-933-3 (technical publication), 2003.
- Cora MacPherson
Tudela E, MacPherson C, and Maibach HI. "Long-term trend in patch test reactions: a 32-year statistical overview (1970-2002), part II." Cutan Ocul Toxicol. 27(3):187-202, 2008.
Mastrobattista JM, Klebanoff MA, Carey JC, Hauth JC, Macpherson CA, Ernest J, Cotroneo M, Leveno KJ, Wapner R, Varner M, Iams JD, Moawad A, Sibai BM, Miodovnik M, Dombrowski M, O'Sullivan MJ, Vandorsten JP, and Langer O. "National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Networks: The effect of body mass index on therapeutic response to bacterial vaginosis in pregnancy." Am J Perinatol. 25(4):233-7, Apr 2008.
Sciscione AC, Landon MB, Leveno KJ, Spong CY, Macpherson C, Varner MW, Rouse DJ, Moawad AH, Caritis SN, Harper M, Sorokin Y, Miodovnik M, Marshall C, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, and Mercer BM. "National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU): Previous preterm cesarean delivery and risk of subsequent uterine rupture." Obstet Gynecol. 111(3):648-53, Mar 2008.
Nguyen SH, Dang TP, MacPherson C, Maibach H, and Maibach HI. "Prevalence of patch test results from 1970 to 2002 in a multi-centre population in North America (NACDG)." Contact Dermatitis. 58(2):101-6, Feb 2008.
- John Adams
Adams J, Sawyer J, and Shiveley L. "Intracellular SPD754 triphosphate pharmacokinetics following administration of SPD754 capsules." 11th Conference on Retroviruses and Opportunistic Infections. San Francisco, CA. Feb 2005. Abstract no. 599.
Shelton MJ, Hewitt RG, Adams J, Della-Coletta A, Cox S, and Morse GD. "Pharmacokinetics of ritonavir and delavirdine in human immunodeficiency virus-infected patients." Antimicrob Agent Chemother 47(5):1694-9, 2003.
Shelton MJ, Hewitt RG, Adams JM, Cox SR, Chambers JH, and Morse GD. "Delavirdine malabsorption in HIV-infected subjects with spontaneous gastric hypoacidity." J Clin Pharmacol 43(2):171-9, 2003.
Smith PF, Forrest A, Adams JM, and Ballow CH. "Effect of food on the pharmacokinetics of (-) and (+) dOTC when administered as an oral racemate." J Clin Pharmacol 42:658-61, 2002.
- Louis Grue
Presentations
Brandon SL, Grue L, and Pearsall M. Presentation to DIA meeting on CRA Training for New and Experienced CRAs, 2005.
Grue L and Pearsall M. Presentation to DIA meeting on Lessons Learned from an Internal Systems Audit of the Training Department, 2004.
Grue L. Presentation to DIA meeting on Building a Training Program in the Pharmaceutical Industry, 2003.
Grue L. Presentation to RAPS Conference on How to Develop a Dynamic Training Program, 2002.
Publications
Espanol J, Grue L, Hoyt MJ. “The Limitations of Training and the Need for Continued Support in the Context of Building International Clinical Trials Infrastructure.” XVI International AIDS Conference, Toronto, 2006.
- Lysa Triantafillou
“Auditing for Human Subject Protection.” Presented at the 2009 Annual Society for Quality Assurance (SQA) Global Conference, San Diego, California, April 2009.
“The Clinical Monitor’s Role in Human Subject Protection.” Full-day tutorial presented at the 2009 Association of Clinical Research Professionals (ACRP) Annual Conference and Training, Denver, Colorado, April 2009.
“IRB Outsourcing: Faster, Better, Cheaper?” Presented at the 2008 MAGI’s Clinical Trial Agreements, Budgets & Regulatory Conference – West, Las Vegas, Nevada, October 2008.
“Auditing for Human Subject Protection.” Presented at the 2008 Annual SQA Global Conference, Memphis, Tennessee, April 2008.
“The Clinical Monitor’s Role in Human Subject Protection.” Full-day paid tutorial presented at the 2008 Annual Association of Clinical Research Professionals (ACRP) Global Conference, Boston, Massachusetts, April 2008.
“Complying with Part 11 at an IRB.” Presented to the Part Eleven Electronic Records and Signature (PEERS) Working Group, Durham, North Carolina, March 2008.