Pediatric Drug Development :... | Buy

Summary

Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.

Author Biography

Andrew E. Mulberg, MD, is Director of Pediatric Drug Development for Johnson and Johnson Pharmaceutical Research and Development, LLC, in Titusville, New Jersey, and is has been editor for four editions of the best-selling 5-Minute Pediatric Consult.

Steven A. Silber, MD, is Vice President for Drug Development and Safety with McNeil Pediatrics, Ortho-McNeil Women's Health and Urology, in Fort Washington, Pennsylvania.

John N. van den Anker, MD, PhD, is Executive Director of the Pediatric Pharmacology Research Unit and Director of Pediatric Clinical Pharmacology at the Children's National Medical Center, Washington, DC, and Professor of Pediatrics, Pharmacology and Physiology at George Washington University, Washington, DC, as well as an Adjunct Professor of Pediatrics at Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.

Past, Present and Future of Pediatric Drug Development
Introduction: Need for a New Model for Children
History of Pediatric Drug Development and Therapeutics
Perspectives on Pediatric Clinical Trials: The Good, the Bad, and the Ugly
Population Dynamics and Demographics of Infants and Children Across the World
Pharmaceutical Economics and Applications to Pediatric Business Case Development
Pediatric Drug Strategy and Development: Considerations for the Pediatric Marketplace
Industry Benchmarks in Pediatric Clinical Trials
Novel organizational strategies for advancing pediatric products
Ethical Underpinnings
Additional Protections for Children Enrolled in Clinical Investigations
Additional Protections for Pregnant Women, Fetus and Neonates
Ethical Principles of Pediatric Research and Drug Development - A Guide Through National and International Frameworks and Applications to a Worldwide Perspective
Past, Present and Future Regulatory Guidances for Pediatric Drug Development: Stimulation of Pediatric Drug Research by Regulatory Authorities
US perspective
Europe perspective
Japan perspective
Regulatory Considerations for Study of Generic Drugs under Best Pharmaceuticals for Children Act:NICHD and FDA Collaboration
Preclinical toxicology: Overview and Introduction
Preclinical Juvenile Toxicity Assessments and Study Designs
Absorption, Distribution, Metabolism and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals
Pharmacological principles in Pediatric Drug development
Pediatric Clinical Pharmacology: Why, Where, How, When?
Developmental Pharmacology Issues: Neonates, Infants and Children
Developmental Hepatic Pharmacology in Pediatrics
Applications of Pharmacogenomics to Study design in Pediatrics
General Principles of Population Pharmacokinetics in Pediatrics
Development of Oncology Drugs for Children
Clinical Trial Operations: Understanding Differences between Pediatric and Adult Study Subjects: Developmental Issues Related to Organ Development and Endpoint Choice
CNS and Brain: Physiological Maturation
Cognitive developmental considerations for long term exposures
Cardiovascular and QTc Issues
Kidney
Growth and Physical Maturation
Clinical Trial Operations and Good Clinical Practices (GCP)
The Consent Process in Pediatric Clinical Trials
Recruitment and retention in Pediatric Clinical trials
Pediatric Good Clinical Practices (GCP)
Considerations and Barriers to Pediatric Patient Recruitment Strategy for Clinical Trials
Conducting Clinical Trials in Developing Countries: A Case Study
Global Clinical trials and Pediatric recruitment
Collaborations with Academia and Clincal Research Centers (CRCs)
Clinical Efficacy and Safety Endpoints
Laboratory Monitoring of Efficacy and Safety Parameters
Breath Testing in Pediatrics
Surrogate Markers
Patient Related Outcomes (PROs)
Safety Monitoring of Pediatric Clin
Table of Contents provided by Publisher. All Rights Reserved.

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