Teratogenicity Testing Methods and Protocols 1st Edition by Luis Filix ISBN 1071636243 9781071636244

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ISBN 10: 1071636243
ISBN 13: 9781071636244
Author: Luis Filix

This fully updated volume collects laboratory techniques and tests to assess the risks to embryo-fetal development from drug exposure during early developmental stages. Beginning with a section detailing basic principles of teratogenicity, the book continues with application of in vitro models for teratogenic screening to predict toxicity in embryonic animals and humans, as well as a variety of well-established in vivo animal model tests, which offer solutions for evaluating the efficacy and the teratogenicity of compounds in preclinical trials before human safety testing. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory prools, and tips on troubleshooting and avoiding known pitfalls.

Authoritative and practical, Teratogenicity Testing: Methods and Prools, Second Edition serves as an ideal guide to tests that can be performed in cells, organs, tissues, and animal models for evaluating toxicity and/or safety of compounds in early developmental stages with the goal of estimating, preventing, or minimizing the teratogenic potential of drugs.

Teratogenicity Testing Methods and Protocols 1st Table of contents:

• Basic Principles of Teratology

  • Mechanisms of Teratogenesis
  • Factors Influencing Teratogenic Effects (e.g., Genetic, Environmental, Timing)
  • Types of Teratogenic Agents: Drugs, Chemicals, Environmental Exposures
  • Critical Periods of Development in Teratogenesis

• In Vitro Methods for Teratogenicity Testing

  • Cell Culture Models and Developmental Toxicity Testing
  • Use of Stem Cells in Teratogenicity Assessment
  • High-Throughput Screening for Teratogenic Compounds
  • Advantages and Limitations of In Vitro Methods

• In Vivo Animal Models for Teratogenicity Testing

  • Common Animal Models (e.g., Mice, Rats, Rabbits)
  • Techniques for Assessing Developmental Toxicity in Animals
  • Postnatal and Long-Term Effects of Teratogenic Exposure
  • Ethical Considerations in Animal Testing

• Embryo and Fetal Developmental Toxicity Testing

  • Methods for Evaluating Developmental Abnormalities
  • Organogenesis and Fetal Development Stages in Testing
  • Teratogenicity Screening Protocols for Drugs and Chemicals
  • Maternal Toxicity vs. Fetal Toxicity

• Genetic and Epigenetic Testing in Teratogenicity

  • The Role of Genetics in Teratogenic Effects
  • Techniques for Assessing Genetic Damage (e.g., Mutagenicity, Chromosomal Aberrations)
  • Epigenetic Mechanisms and Their Impact on Teratogenicity

• Pharmacokinetics in Teratogenicity Testing

  • Absorption, Distribution, Metabolism, and Excretion (ADME) of Teratogenic Agents
  • Drug Placental Transfer and Its Relevance to Testing
  • Dosage and Timing Considerations in Teratogenicity Studies

• Teratogenicity Testing Protocols

  • Standard Operating Procedures (SOPs) for Teratogenicity Studies
  • Designing and Conducting In Vivo and In Vitro Studies
  • Data Analysis and Interpretation in Teratogenicity Testing
  • Reporting and Regulatory Documentation

• Emerging Trends and Technologies in Teratogenicity Testing

  • Advances in 3D Culture Models and Organoids
  • Use of CRISPR and Genetic Engineering in Teratogenicity Testing
  • Biomarkers for Early Detection of Teratogenic Effects
  • Computational Toxicology and Predictive Modeling

• Regulatory and Ethical Considerations

  • Regulatory Agencies and Guidelines (FDA, EPA, OECD)
  • Ethical Issues in Teratogenicity Testing
  • Alternative Testing Methods: The 3Rs (Replace, Reduce, Refine)
  • International Harmonization of Teratogenicity Testing Protocols

• Case Studies in Teratogenicity

  • Real-World Examples of Teratogenicity Testing Outcomes
  • Case Studies of Known Teratogens: Thalidomide, Alcohol, Tobacco, and Others
  • Lessons Learned and Impact on Regulatory Policies

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