Pharmaceutical Book from C.H.I.P.S.

Pediatric Drug Development
Concepts and Applications
by Andrew E. Mulberg

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.


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

  1. Additional Protections for Children Enrolled in Clinical Investigations
  2. Additional Protections for Pregnant Women, Fetus and Neonates
  3. 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

  1. US perspective
  2. Europe perspective
  3. Japan perspective
  4. Regulatory Considerations for Study of Generic Drugs under Best Pharmaceuticals for Children Act:NICHD and FDA Collaboration

Preclinical toxicology: Overview and Introduction

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

Pharmacological principles in Pediatric Drug development

  1. Pediatric Clinical Pharmacology: Why, Where, How, When?
  2. Developmental Pharmacology Issues: Neonates, Infants and Children
  3. Developmental Hepatic Pharmacology in Pediatrics
  4. Applications of Pharmacogenomics to Study design in Pediatrics
  5. General Principles of Population Pharmacokinetics in Pediatrics
  6. 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

  1. CNS and Brain: Physiological Maturation
  2. Cognitive developmental considerations for long term exposures
  3. Cardiovascular and QTc Issues
  4. Kidney
  5. Growth and Physical Maturation

Clinical Trial Operations and Good Clinical Practices (GCP)

  1. The Consent Process in Pediatric Clinical Trials
  2. Recruitment and retention in Pediatric Clinical trials
  3. Pediatric Good Clinical Practices (GCP)
  4. Considerations and Barriers to Pediatric Patient Recruitment Strategy for Clinical Trials
  5. Conducting Clinical Trials in Developing Countries: A Case Study
  6. Global Clinical trials and Pediatric recruitment
  7. Collaborations with Academia and Clincal Research Centers (CRCs)

Clinical Efficacy and Safety Endpoints

  1. Laboratory Monitoring of Efficacy and Safety Parameters
  2. Breath Testing in Pediatrics
  3. Surrogate Markers
  4. Patient Related Outcomes (PROs)
  5. Safety Monitoring of Pediatric Clinical Trials
  6. Post-Marketing Safety Surveillance

Formulation/Chemistry/Manufacturing Controls

  1. Liquids, Suspensions, Tablets
  2. Drug Delivery Challenges for the Pediatric Patient: Novel forms for Consideration
  3. Drug Delivery Challenges for the Pediatric Patient: Oral Forms for Consideration
  4. The Jelly Bean Test: A Novel Technique To Help Children Swallow Medications

Case Studies: Successes for Children

  1. A Case Study of Psychiatric Research in Children ? The Risperdal Example
  2. Topamax
  3. Ascent Pediatrics
  4. DCI Pancrecarb


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Pediatric Drug Development
Concepts and Applications
by Andrew E. Mulberg

2009 683 pages $115.00 + shipping
Texas residents please add 6.75 % sales tax

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