Pediatric Drug Development: Concepts and Applications / Edition 1

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $33.24
Usually ships in 1-2 business days
(Save 78%)
Other sellers (Hardcover)
  • All (5) from $33.24   
  • New (3) from $82.83   
  • Used (2) from $33.24   
Sort by
Page 1 of 1
Showing All
Note: Marketplace items are not eligible for any coupons and promotions
Seller since 2010

Feedback rating:



New — never opened or used in original packaging.

Like New — packaging may have been opened. A "Like New" item is suitable to give as a gift.

Very Good — may have minor signs of wear on packaging but item works perfectly and has no damage.

Good — item is in good condition but packaging may have signs of shelf wear/aging or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Acceptable — item is in working order but may show signs of wear such as scratches or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Used — An item that has been opened and may show signs of wear. All specific defects should be noted in the Comments section associated with each item.

Refurbished — A used item that has been renewed or updated and verified to be in proper working condition. Not necessarily completed by the original manufacturer.

Brand New. US Edition Book. We do not ship to Military Addresses. Fast Shipping with Order Tracking. For Standard Shipping 7-8 business days & Expedite Shipping 4-6 business days, ... after shipping. Read more Show Less

Ships from: Sugar Land, TX

Usually ships in 1-2 business days

  • Standard, 48 States
  • Standard (AK, HI)
  • Express, 48 States
  • Express (AK, HI)
Seller since 2008

Feedback rating:


Condition: New
Brand New, Perfect Condition, Please allow 4-14 business days for delivery. 100% Money Back Guarantee, Over 1,000,000 customers served.

Ships from: Westminster, MD

Usually ships in 1-2 business days

  • Canadian
  • International
  • Standard, 48 States
  • Standard (AK, HI)
Seller since 2008

Feedback rating:


Condition: New
New Book. Shipped from UK within 10 to 14 business days. Established seller since 2000.

Ships from: Horcott Rd, Fairford, United Kingdom

Usually ships in 1-2 business days

  • Standard, 48 States
  • Standard (AK, HI)
Page 1 of 1
Showing All
Sort by


Pediatric Drug Development, Second Edition, encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of pediatric drug development.

Read More Show Less

Product Details

  • ISBN-13: 9780470169292
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 4/13/2009
  • Edition description: Older Edition
  • Edition number: 1
  • Pages: 704
  • Product dimensions: 7.20 (w) x 9.90 (h) x 1.60 (d)

Meet the Author

Andrew E. Mulberg, Division Deputy Director, Gastroenterology and Inborn Error Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, US

Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, US

Julia Dunne, Vigilance and Risk Management in Medicines (VRMM), Medicines and Healthcare Products Regulatory Agency, London, UK

Lisa L. Mathis, Executive Director for Global Regulatory Affairs and Safety (GRAAS), Amgen Incorporated, Thousand Oaks, California, US

Read More Show Less

Table of Contents

List of Contributors


1 Pediatric Drug Development and Therapeutics: Continued Progress for Better Drugs for Children
Andrew E. Mulberg, Lisa Mathis, Julia Dunne and Dianne Murphy

2 History of Children and the Development of Regulations at the FDA
Robert M. Ward and Steven Hirschfeld

3 Population Dynamics, Demographics, and Disease Burden of Infants and Children Across the World
Ashley Malins and Christopher-Paul Milne

4 Pharmaceutical Economics and Market Access for Pediatric  Medications
Christopher-Paul Milne and Ashley Malins

5 The Global Pediatric Market and Drivers of Pediatric Drug Development
E. Michael D. Scott

6 Industry Benchmarks in Pediatric Clinical Trials
Carolyn A. Campen and Cindy Levy-Petelinkar

7 Ethical and practical considerations in conducting neonatal research
Michelle Roth-Cline and Robert M. Nelson

8 Ethical considerations in conducting pediatric research 
Michelle Roth-Cline and Robert M. Nelson

9 The Consent and Assent Process in Pediatric Clinical Trials
M. Renee Simar

10 A Sponsor’s Perspective of US Regulations
Samuel Maldonado

11 FDA experience of extrapolation of efficacy to the pediatric population from adult and other data
Julia Dunne, William J. Rodriguez and Dianne Murphy

12 Accelerated Approval and other regulatory approaches to the development of drugs for serious or life-threatening diseases in pediatrics
Therese Cvetkovich

13 Rare Diseases and Orphan Drugs
Anne R. Pariser and Lynne P. Yao

14 European Perspective
Agnès Saint-Raymond

15 Five years of pediatric legislation in the European Union
Agnès Saint-Raymond and Ralf Herold

16 Japanese Perspective
Hidefumi Nakamura and Shunsuke Ono

17 Pediatric Device Development in the United States
Priya Venkataraman-Rao and Joy Samuels-Reid

18 Introduction and Overview
Timothy P. Coogan and Melissa S. Tassinari

19 Juvenile Animal Toxicity Assessments: Decision Strategies and Study Design
Luc M. De Schaepdrijver,  Graham P. Bailey, Timothy P. Coogan and Jennifer L. Ingram-Ross

20 Absorption, Distribution, Metabolism and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals
Loeckie L. de Zwart, Johan G. Monbaliu and Pieter P. Annaert

21 A Global Regulatory Perspective
Karen Davis-Bruno, Jacqueline Carleer, Beatriz Silva Lima and Melissa S. Tassinari

22 Disease specific models to enhance Pediatric drug development
Niraj R. Mehta and Sruthi King

23 Pediatric Clinical Pharmacology in Regulatory and Drug Development Sciences:  Lessons learned and the Path Forward
Gilbert J. Burckart and Jeremiah Momper

24 Development and Clinical Trial Design
Kathleen A. Neville, Ralph E. Kauffman, and Susan M. Abdel-Rahman

25 Developmental Hepatic Pharmacology in Pediatrics
Martin Otto Behm

26 Applications of Population Pharmacokinetics for Pediatric Drug Development
Jeremiah Momper, Gilbert J. Burckart and Pravin Jadhav

27 Applications of Pharmacogenomics to Pediatric Drug Development 
Gilbert J. Burckart, Dionna Green and Padmaja Mummaneni

28 Pharmacometrics Applications to Pediatric Trials
Devin Pastoor, Mallika Lala, Jogarao V.S. Gobburu

29 Brain and Central Nervous System Development: Physiological Considerations for Assessment of Long-Term Safety
Kachikwu Illoh

30 Cognitive Development Considerations for Long-Term Safety Exposures in Children
Mary Pipan, Paul Wang,  and Rebecca Thompson-Penna

31 Cardiovascular and QTc Issues
Bert Suys and  Luc Dekie

32 Pediatric bone and adult bone – physiological differences
Francisco A. Sylvester and Erica L. Wynn

33 Renal Function Issues
Katia Boven

34 Growth and Physical Development
Alisha J. Rovner and  Babette S. Zemel

35 Development of Drugs for Pediatric Cancers
Kristen M. Snyder, Martha Donoghue, Whitney S. Helms, and Gregory Reaman

36 Recruitment and Retention in Pediatric Clinical Trials: Focus on Networks  in the US and EU Rosalind L. Smyth, Geetinder Kaur, Daniel Benjamin Jr, and Matthew Laughon

37 Recruitment and Retention of Minority populations in Clinical Trials
Benjamin Ortiz and Sergio Guerrero

38 Conducting Clinical Trials in Developing and Emerging Countries:  Review and Case Study
Kevin D. Hill and Jennifer S. Li

39 The Importance of Geographic Differences in Pediatric Clinical Trials
Alexandar Cvetkovich Muntañola

40 Clinical Laboratory Testing in Clinical Trials for Pediatric Subjects
Andrew E. Mulberg and Ethan D. Hausman
41 Surrogate Endpoints: Application in Pediatric Clinical Trials
Geert Molenberghs

42 Clinical Outcome Assessments for Clinical Trials in Children
Elektra J. Papadopoulos,  Donald L. Patrick,  Melissa S. Tassinari,  Andrew E. Mulberg,  Carla Epps,  Anne R. Pariser and  Laurie B. Burke

43 Challenges in Evaluating the Safety of Pediatric Therapeutic Agents in Trials and Post-Marketing Studies
Ann W. McMahon, Chris Feudtner and Dianne Murphy

44 Endpoints in Rare Diseases
Anne R. Pariser and Lynne P. Yao

45 Formulation, Chemistry, and Manufacturing Controls
Gerard P. McNally and Aniruddha M. Railkar

46 Drug Delivery Challenges for the Pediatric Patient: Novel Forms for  Consideration
Ann Zajicek
47 The Jelly Bean Test: A Novel Technique To Help Children Swallow Medications
Robbyn E. Sockolow and Aliza B. Solomon


Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Terms of Use.
  • - Barnes & reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)