Genotoxic Impurities

Foreword.
Preface.
Section I: Development of GI Guidelines and the TTCConcept.
Chapter 1. Historical Overview of the Development of GenotoxicImpurities Guidelines and their Impact (R. Ogilvie and A.Teasdale).
Chapter 2. Development of the Threshold of Toxicological ConcernConcept (TTC) and its Relationship to Duration of Exposure (A.Brigo and L. Muller).
Section 2: Evaluation of Genotoxic Risk from a Pre-clinicalPerspective.
Chapter 3. Genetic Toxicity Testing to Qualify AlertingImpurities (M. O'Donovan).
Chapter 4. Use of Structure Activity Relationship (SAR)Evaluation as a Critical Tool in the Evaluation of the GenotoxicPotential of Impurities (S. Glowienke and C. Hasselgren).
Chapter 5. Compound-Specific Risk Assessments for GenotoxicImpurities: Examples and Issues (A. Teasdale and C. Humfrey).
Chapter 6. Human Genotoxic Metabolites: Identification and Risk(K. Dobo, D. Walker and A. Teasdale).
Section 3. Perspective on Risk Posed by GenotoxicImpurities.
Chapter 7. Genotoxic Thresholds (G. Jenkins, G. Johnson, J.Parry and S. Doak).
Chapter 8. Genotoxic Impurities a Risk in Perspective? (D.Elder).
Section 4. Assessment of Genotoxic Risk: QualityPerspective.
Chapter 9. Strategies for the Evaluation of Genotoxic ImpurityRisk (A. Teasdale, S. Fenner and D. Elder).
Chapter 10. Analysis of Genotoxic Impurities: Review ofApproaches (D. Elder).
Chapter 11. Development of a Strategy for Analysis of GenotoxicImpurities (Andrew Baker).
Chapter 12. Strategic Approaches to the Chromatograpic Analysisof Genotoxic Impurities (Frank David, Karine Jacq, GerdCanhoenacker and Pat Sandra).
Chapter 13. Analysis of Genotoxic Impurities by NuclearResonance (NMR) Spectroscopy (Andrew Philips).
Chapter 14. Mechanism and Processing Parameters Affecting theFormation of Sulfonate Esters: Summary of the PQRI Studies -PQRI Working Group (Andrew Teasdale).
Chapter 15. Aspects to Consider when Devising a Strategy toUnderstand if Low Level API/DP Degradants have the Potential forGenotoxicity (Alan P. McKeown and Andrew Teasdale).