Preclinical Safety Book from C.H.I.P.S.

Preclinical Safety Evaluation of Biopharmaceuticals
A Science-Based Approach to Facilitating Clinical Trails
edited by Joy A. Cavagnaro

Preclinical Safety Evaluation of Biopharmaceuticals covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals.

Preclinical Safety Evaluation of Biopharmaceuticals addresses all aspects of the preclinical evaluation process, including:

  • the selection of relevant species
  • safety/toxicity endpoints
  • specific considerations based upon class
  • practical considerations in the design, implementation, and analysis of biopharmaceuticals


  1. Biopharmaceuticals: Definition and Regulation
  2. Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact
  3. The Principles of ICH S6 and the Case-by-Case Approach
  4. Implementation of ICH S6: EU Perspective
  5. Implementation of ICH S6: Japanese Perspective
  6. Implementation of ICH S6: US Perspective
  7. Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies, Timing, Materials, and Costs
  8. Demonstration of Comparability of a Licensed Product after a Manufacturing Change
  9. Selection of Relevant Species
  10. Tissue Cross-Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity Testing
  11. Physiologic IgG Biodistribution, Transport, and Clearance: Implications for Monoclonal Antibody Products
  12. The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species
  13. Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals
  14. Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals
  15. Genetic Toxicity Testing of Biopharmaceuticals
  16. General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals
  17. Reproductive Toxicity Testing for Biopharmaceuticals
  18. Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates
  19. Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals
  20. Immunogenicity of Therapeutic Proteins and the Assessment of Risk
  21. Assessment of Autoimmunity and Hypersensitivity
  22. Current Practices in the Preclinical Safety Assessment of Peptides
  23. Enzyme Replacement Therapies
  24. Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities
  25. Preclinical Saxfety Evaluation of Biological Oncology Drugs
  26. Preclinical Safety Evaluation of Monoclonal Antibodies
  27. Immunomodulatory Biopharmaceuticals and Risk of Neoplasia
  28. Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics
  29. Preclinical Safety Evaluation of Immunotoxins
  30. Preclinical Safety Evaluation of Blood Products
  31. Preclinical Safety Evaluation of Viral Vaccines
  32. Preclinical Safety Evaluation of Biopharmaceuticals
  33. Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies
  34. Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products
  35. Tissue Engineered Products: Preclinical Development of Neo-Organs
  36. GLP Requirements and Current Practices
  37. Preclinical Safety Study Design Templates and Estimated Costs
  38. Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals
  39. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals
  40. Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals


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Preclinical Safety Evaluation of Biopharmaceuticals
A Science-Based Approach to Facilitating Clinical Trails
edited by Joy A. Cavagnaro

2008 1033 pages $149.00 + shipping
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