Sale!

Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st Edition by Alan M Hoberman, Elise M Lewis ISBN 047044861X 9780470448618

Original price was: $50.00.Current price is: $35.00.

Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st Edition Alan M. Hoberman Digital Instant Download

Author(s): Alan M. Hoberman, Elise M. Lewis
ISBN(s): 9780470448618, 047044861X
Edition: 1
File Details: PDF, 3.13 MB
Year: 2012
Language: english
SKU: EB-4446738 Category: Tags: ,

Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st Edition by Alan M Hoberman, Elise M Lewis – Ebook PDF Instant Download/Delivery: 047044861X, 9780470448618
Full download Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st Edition after payment

Product details:

ISBN 10: 047044861X 
ISBN 13: 9780470448618
Author: Alan M Hoberman, Elise M Lewis

This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.

Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st Table of contents:

Part I: General Principles and Regulatory Landscape

  1. Introduction to Pediatric Drug Development and Nonclinical Testing
    • The Need for Pediatric Drug Development
    • Challenges Unique to Pediatric Populations
    • Overview of the Nonclinical Testing Paradigm
  2. Regulatory Requirements and Guidance Documents
    • ICH Guidelines (e.g., ICH S5, ICH M3)
    • US FDA Regulations (e.g., Pediatric Rule, BPCA, PREA)
    • European Medicines Agency (EMA) Requirements (e.g., Paediatric Regulation, PIP)
    • Japanese PMDA and Other International Guidelines
  3. Ethical Considerations in Pediatric Nonclinical Testing
    • Justification for Animal Use
    • Principles of Replacement, Reduction, and Refinement (3Rs)
    • Balancing Scientific Need with Animal Welfare
  4. Species Selection and Development
    • Choosing Appropriate Animal Models for Pediatric Studies
    • Understanding Developmental Milestones in Animals Relevant to Humans
    • The Concept of “Juvenile Animal Studies”

Part II: Scientific Principles and Study Designs

  1. Pharmacokinetics (PK) in Developing Animals
    • Absorption, Distribution, Metabolism, and Excretion (ADME) Differences in Juveniles
    • Age-Related Changes in Enzyme Activity and Organ Function
    • Designing PK Studies in Juvenile Animals
  2. Pharmacodynamics (PD) in Developing Animals
    • Age-Related Differences in Receptor Expression and Responsiveness
    • Impact of Development on Drug Efficacy and Safety Biomarkers
  3. General Toxicity Studies in Juvenile Animals
    • Rationale for Juvenile Toxicity Studies
    • Study Design Considerations (Dosing, Duration, Endpoints)
    • Clinical Pathology, Histopathology, and Organ Weight Analysis in Juveniles
  4. Reproductive and Developmental Toxicity Considerations
    • How Adult Reproductive Toxicology Studies Inform Pediatric Risk
    • Specific Considerations for Drugs Affecting Puberty and Reproductive Maturation
  5. Specialized Toxicity Endpoints in Juvenile Animals
    • Neurodevelopmental Toxicity: Assessment of Behavioral, Cognitive, and Structural Changes
    • Bone and Cartilage Toxicity: Impact on Growth Plates and Skeletal Development
    • Renal and Hepatic Development: Functional and Morphological Assessment
    • Immunotoxicity: Developing Immune System Response
    • Cardiovascular and Respiratory Development: Functional Assessment
  6. Carcinogenicity Testing and Juvenile Animals
    • When and How Carcinogenicity Studies are Conducted in Relation to Pediatric Use
    • Specific Sensitivities of Developing Organs to Carcinogens

Part III: Practical Application and Management

  1. Bridging Strategies and Extrapolation
    • Using Adult Nonclinical Data to Support Pediatric Development
    • The Concept of “Waivers” and “Deferrals”
    • Justification for Not Conducting Juvenile Animal Studies
  2. Study Conduct and Interpretation
    • Practical Aspects of Conducting Juvenile Animal Studies
    • Data Analysis and Interpretation Unique to Developmental Studies
    • Identifying and Characterizing Adverse Developmental Effects
  3. Reporting and Regulatory Submissions
    • Content and Format of Nonclinical Study Reports for Pediatric Programs
    • Interacting with Regulatory Agencies
    • Addressing Regulatory Questions and Deficiencies
  4. Case Studies in Pediatric Nonclinical Drug Development
    • Examples of Successful Pediatric Drug Development Programs
    • Cases Where Juvenile Animal Studies Revealed Unique Risks
    • Lessons Learned from Past Experiences
  5. Future Directions in Pediatric Nonclinical Drug Testing
    • New Technologies and In Vitro/In Silico Models
    • Biomarker Development for Developmental Toxicity
    • Harmonization of Global Regulatory Guidelines
    • The Role of Real-World Data and Post-Marketing Surveillance

People also search for Pediatric Non Clinical Drug Testing Principles Requirements and Practice 1st:

pediatric non clinical drug testing principles
    
nonclinical safety evaluation of pediatric drug products
    
pediatric drug testing
    
pediatric clinical trial guidelines
    
pediatric clinical practice guidelines pdf

 

Tags: Alan M Hoberman, Elise M Lewis, Pediatric, Clinical