Pediatric Drug Development: Concepts and Applications addresses 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.

Contents

Past, Present and Future of Pediatric Drug Development

1. Introduction: Need for a New Model for Children
2. History of Pediatric Drug Development and Therapeutics
3. Perspectives on Pediatric Clinical Trials: The Good, the Bad, and the Ugly
4. Population Dynamics and Demographics of Infants and Children Across the World
5. Pharmaceutical Economics and Applications to Pediatric Business Case Development
6. Pediatric Drug Strategy and Development: Considerations for the Pediatric Marketplace
7. Industry Benchmarks in Pediatric Clinical Trials
8. Novel organizational strategies for advancing pediatric products

Ethical Underpinnings

9. Additional Protections for Children Enrolled in Clinical Investigations
10. Additional Protections for Pregnant Women, Fetus and Neonates
11. 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

12. US perspective
13. Europe perspective
14. Japan perspective
15. Regulatory Considerations for Study of Generic Drugs under Best Pharmaceuticals for Children Act:NICHD and FDA Collaboration

Preclinical toxicology: Overview and Introduction

16. Preclinical Juvenile Toxicity Assessments and Study Designs
17. Absorption, Distribution, Metabolism and Excretion (ADME) and Pharmacokinetic Assessments in Juvenile Animals

Pharmacological principles in Pediatric Drug development

18. Pediatric Clinical Pharmacology: Why, Where, How, When?
19. Developmental Pharmacology Issues: Neonates, Infants and Children
20. Developmental Hepatic Pharmacology in Pediatrics
21. Applications of Pharmacogenomics to Study design in Pediatrics
22. General Principles of Population Pharmacokinetics in Pediatrics
23. 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

24. CNS and Brain: Physiological Maturation
25. Cognitive developmental considerations for long term exposures
26. Cardiovascular and QTc Issues
27. Kidney
28. Growth and Physical Maturation

Clinical Trial Operations and Good Clinical Practices (GCP)

29. The Consent Process in Pediatric Clinical Trials
30. Recruitment and retention in Pediatric Clinical trials
31. Pediatric Good Clinical Practices (GCP)
32. Considerations and Barriers to Pediatric Patient Recruitment Strategy for Clinical Trials
33. Conducting Clinical Trials in Developing Countries: A Case Study
34. Global Clinical trials and Pediatric recruitment
35. Collaborations with Academia and Clincal Research Centers (CRCs)

Clinical Efficacy and Safety Endpoints

36. Laboratory Monitoring of Efficacy and Safety Parameters
37. Breath Testing in Pediatrics
38. Surrogate Markers
39. Patient Related Outcomes (PROs)
40. Safety Monitoring of Pediatric Clinical Trials
41. Post-Marketing Safety Surveillance

Formulation/Chemistry/Manufacturing Controls

42. Liquids, Suspensions, Tablets
43. Drug Delivery Challenges for the Pediatric Patient: Novel forms for Consideration
44. Drug Delivery Challenges for the Pediatric Patient: Oral Forms for Consideration
45. The Jelly Bean Test: A Novel Technique To Help Children Swallow Medications

Case Studies: Successes for Children

46. A Case Study of Psychiatric Research in Children ? The Risperdal Example
47. Topamax
48. Ascent Pediatrics
49. DCI Pancrecarb

Appendices
Index

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