Publications

From the Office of Pediatric Therapeutics and FDA

 

Limited to the last 3 years.  

A)    PEER REVIEWED ARTICLES PUBLISHED

1- Device Safety and Effectiveness in the Pediatric Population: A US FDA Perspective.

Joy Samuels-Reid, Judith U. Cope, and Audrey E. Morrison

Expert Reviews; Med. Devices 6(2), 131-135 (2009)

 

2-Amoxicillin For Post-Exposure Inhalational Anthrax (Peia) In Pediatrics: Rationale For Dosing Recommendations

J. J. Alexander M.D., MPH.; P. M. Colangelo PharmD, Ph.D.,; C. K. Cooper M.D.; R. Roberts M.D.; W. J. Rodriguez M.D.; M. D. Murphy M. D

Pediatric Infectious Disease Journal, Volume 27, No. 11, November 2008

 

3-Pediatric Drug Surveillance and the Food and Drug Administration’s Adverse Events Reporting System: An Overview of Reports, 2003-2007 Rosemary Johann-Liang MD, Jo Wyeth Pharm D, Min Chen MS, MPH, and Judith Cope MD, MPH

Pharmacopepidemiology and Drug Safety (2008), November, DOI:10.1002/pds.1679

 

4-*Racial Difference in Blood Pressure Response to Angiotensin Converting Enzyme Inhibitors in Children:  A Meta Analysis

Jennifer S. Li MD MHS, Carissa M. Baker-Smith MD, P. Brian Smith MD, Vic Hasselblad PhD, M. Dianne Murphy MD, Robert M. Califf MD, Daniel K. Benjamin Jr. MD PhD Clinical Pharmacology and Therapeutics: September 2008, Vol. 84, Issue 3, p.315-319

 

5-*Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity P. Brian Smith, MD, MHS, Daniel K. Benjamin, Jr., MD, PhD, MPH M. Dianne Murphy, MD, Rosemary Johann-Liang, MD, Solomon Iyasu, MD, Robert M. Califf, MD, Jennifer S. Li, MD, MHS, and William Rodriguez, MD, PhD Pediatrics, Sept. 2008, Vol. 122, Issue 3. e 628-633

 

6-Adolescent Use of Insulin and Patient Controlled Analgesia Pump Technology: A 10-year FDA Retrospective Study of Adverse Events

Judith U. Cope, MD, MPH¹, Audrey E. Morrison, RN, BScN¹, and Joy Samuels-Reid, MD, FAAP²   Pediatrics 2008; e1133-e1138, Sept. 2008

 

7-*Pediatric Antihypertensive Trial Failures: Analysis of Endpoints and Dose Range Daniel K. Benjamin, Jr., MD, PhD, MPH; P. Brian Smith, MD; Pravin Jadhav, PhD;Jogarao V. Gobburu, PhD; M. Dianne Murphy, MD; Victor Hasselblad, PhD; Carissa Baker-Smith, MD; Robert M. Califf, MD; and Jennifer S. Li, MD, MHS Hypertension 2008; 51; 834-840, March 10, 2008

 

8-Improving Pediatric Dosing Through Pediatric Initiatives – What We Have Learned

William Rodriguez, M.D., Ph.D.; Arzu Selen, Ph.D.; Debbie Avant, R.Ph.; Chandra Chaurasia, Ph.D.; Terrie Crescenzi, R.Ph.; Gerlie Gieser, Ph.D.; Jennifer Di Giacinto, Pharm.D.; Shiew-Mei Huang, Ph.D.;  Peter Lee, Ph.D.; Lisa Mathis, M.D.; Dianne Murphy, M.D.; Shirley Murphy, M.D.; Rosemary Roberts, M.D.; Hari Cheryl Sachs, M.D.; Sandra Suarez, Ph.D.; Veneeta Tandon, Ph.D.; and Ramana S. Uppoor, Ph.D.    Pediatrics Vol. 121, Number 3, March 2008

 

9-*Safety of Placebo Controls in Pediatric Hypertension Trials, - Brian Smith MD MHS, Jennifer Li MD MHS, Dianne Murphy MD, Robert M. Califf and Daniel K Benjamin MD PhD MPH, Hypertension 2008; 51; 829-833, February 19, 2008

 

10-*Economic Return of Clinical Trials Performed

Under the Pediatric Exclusivity Program Jennifer S. Li, MD, MHS,Eric L. Eisenstein, DBA,Henry G. Grabowski, PhD,Elizabeth D. Reid,,Barry Mangum, PharmD,Kevin A.. Schulman, MD,John V. Goldsmith, PhD,M. Dianne Murphy, MDRobert M. Califf, MD,Daniel K. Benjamin, Jr, MD, PhD

JAMA, February 7, 2007—Vol 297, No. 5

 

11-*Peer-Reviewed Publication of Clinical Trials Completed for Pediatric Exclusivity,Daniel K. Benjamin, Jr, MD, PhD, Philip Brian Smith, MD,M. Dianne Murphy, MD, Rosemary Roberts, MD, Lisa Mathis, MD, Debbie Avant, RPh, Robert M. Califf, MD, Jennifer S. Li, MD, MHS  

JAMA, September 13, 2006—Vol. 296, No. 10

 

12-More Appropriate Clinical Trial Design for Drug Labels.

McCunne S, Mathis L,Cochetto D, Ball S and Rodriguez W. Drug Information Journal 2006; 40:185-195

 

13-Criteria Supporting the Study of Drugs in the Newborn.

Ward R, Benitz E, Benjamin D. Blackmon L., Giacoia G.,Huddack M., Lasky T.,   RodriguezW and Selen A. Clinical Therapeutics 2006; 28:1385-1398

 

B)    ACCEPTED:

 

Pediatric Drug Trials: Safety and Transparency

Danny K Benjamin, P Brian Smith, M Jessica Sun, M Dianne Murphy, Debbie Avant, Lisa Mathis, Robert M Califf and Jennifer S. Li.

Accepted:  Archives of Diseases in Pediatrics and Adolescent Medicine

 

Drug Therapy In Pediatrics: A Developing Field

Lisa Mathis, MD and William Rodriguez, MD

Accepted: by the Dermatologic Therapy Journal

 

Developmental Dysplasia Of The Hip—Child                                                         

Expert Panel on Pediatric Imaging: Boaz K. Karmazyn, MD¹; Richard Gunderman, MD, PhD²; Brian D. Coley, MD³; Ellen R. Blatt, MD⁴; Dorothy Bulas, MD⁵;Lynn Fordham, MD⁶;Daniel J. Podberesky, MD⁷;Jeffrey Scott Prince, MD⁸; Charles Paidas, MD⁹; William Rodriguez, MD ¹⁰             

Accepted: to be published in the August 2009 issue of the Journal of the American College of Radiology (JACR).

  

 

Chapters:

Pharmacovigilance in Pediatrics

Solomon Iyasu, MD, PMH and Dianne Murphy, MD in Pharmacovigilance, 2^nd Edition,

Editors: R.D. Mann and Andrews.  Published by Wiley & Sons, January 2007

 

Pediatric Medical Device Use. Judith Cope, MD, MPH and Thomas Gross, MD, MPH. Chapter 15: Medical Device Epidemiology and Surveillance. Pages 203-218.Editors:Brown SL, Bright RA, Tavris DR. Published by Wiley & Sons, Ltd., 2007.

 

Labeling of Pediatric Pain Medications In "Pain in Children: A Practical Guide for Primary Care,” Hari Cheryl Sachs, MD, FAAP, DebbieAvant, R.Ph, and William Rodriguez, MD, PhD, Editor Gary A. Walco, PhD and Kenneth R. Goldshneider, MD

Published by Humana Press, July 2008

 

“Additional Protections for Children Enrolled in Clinical Investigations.”

Pages 81-102 in Pediatric Drug Development: Concepts and Applications, by Robert “Skip” Nelson” edited by Andrew E. Mulberg, Steven Silber, and John N. van den Anker.

ISBN: 978-0-470-16929-2, Hardcover, 683 pages, April 2009, Wiley-Blackwell.

 

“Penicillins, Beta-Lactamase Inhibitors, Cephalopsporins, and Other Beta-Lactams,” in Neonatal and Pediatric Pharmacology: Therapeutic Principles in Practice, Fourth Edition, by Sumathi Nambiar and William J. Rodriguez edited by Sumner J. Yaffe and Jacob V. Aranda. To be published early in 2009 

 

Work directed by the Duke IPA faculty is identified by an *.