Molecular Diagnostics

This unique book provides a thorough overview of developing molecular cancer diagnostic assays, which are the prerequisites for optimal solutions within personalized cancer medicine. The book takes the reader through definitions of the pharmacodiagnostic concept, historical perspectives of the early steps into molecular cancer diagnostics linked to therapy, the basis of different diagnostic molecular techniques, ongoing research, drug-diagnostic co-development, assay validation, clinical trial methodology, regulatory issues around pharmacodiagnostics and future aspects within personalized cancer medicine.

Auteur

Dr Jan Trost Jorgensen holds an MSc degree in pharmacy and a PhD in clinical pharmacy from the Faculty of Pharmaceutical Sciences, University of Copenhagen. He has worked with drug development in biotech and pharmaceutical companies for more than 25 years, and within the last 10 years his focus has been on drug-diagnostic co-development projects within cancer. Dr Jorgensen is a strong supporter of more individualized pharmacotherapy and has published a number of scientific papers on oncology as well as on stratified and personalized medicine.

Contenu

Developing Molecular Diagnostics for Cancer. The Estrogen & Progesterone Receptor- Setting the Scene for Pharmacodiagnostics. The HercepTest- From Bench to Bedside. Pharmacodiagnostics and Translational Cancer Medicine. Pharmacodiagnostic Testing- Immunohistology. In Situ Hybridisation for Pharmacodiagnostic Testing. Pharmacodiagnostics Test- Microarray. DNA Biomarkers in the Diagnosis and Management of Cancer. Validating the Analytical Power of a Pharmacodiagnostic Test. Drug and Pharmacodiagnostic Co-Development Statistical Considerations. Clinical Validation of Biomarkers in Cancer. Pharmacogenomic Markers for Cancer Therapy. Safety and Efficacy Biomarkers in Oncology Drug Label and Clinical Usage: A Regulatory Perspective. Image Analysis Systems for Cancer Diagnostics. Personalizing Treatment Selection for Breast Cancer. Pharmacodiagnostics and Personalized Medicine in Cancer.