With all the multitude of challenges facing the pharmaceutical research and development process, the industry is actively exploring the relationships between human genetics and drug responsiveness, susceptibility to disease and disease severity. In Pharmacogenomics and Personalized Medicine, leading experts from the pharmaceutical industry, the scientific community and the government provide guidance for conducting pharmacogenomic research from discovery to the market, while also presenting a realistic perspective on the challenges, practicalities and obstacles in its application. Focusing on DNA data and associatedanalytical methodologies, with a consideration for complementary RNA-based studies, this volume includes a wide array of vital, cutting-edge research. Aidsin pharmacogenomic study feasibility assessment and pharmaceutical business decision-making Contains the pharmacogenomics protocols, informed consent form,and applications in adverse drug reactions, drug discovery and clinical trials Describes the regulatory environment and labeling implications, marker selection, study design and statistical methods in pharmacogenomics research INDICE: From the contents Challenges, Opportunities and Evolving Landscapein Pharmacogenomics and Personalized Medicine: An Industry Perspective.- Considerations for Sample Collections Intended for Pharmacogenomic analyses: The Pharmacogenomics protocol and informed consent form.- Pharmacogenomics: The Regulatory Environment and Labeling Implication.- Applications of Pharmacogenomics in Drug Discovery.- Applications of Pharmacogenomics in Clinical Trials.- Pharmacogenomics applications in drug metabolism: from genotyping to drug label-challenges?- The Genetics of Adverse Drug Reactions – Promises and Problems.- Strategies and resources for marker selection and genotyping in genetic association studies.- Study Design and Statistical Methods in Pharmacogenomics Research: From Candidate Genes to Genome Wide Screens.- Holy SNP, Batman!- Use of Predictive Biomarker Classifiers in the Design of Pivotal Clinical Trials.- Translation of biomarkers into clinical utility.
- ISBN: 978-1-934115-04-6
- Editorial: Humana
- Encuadernacion: Cartoné
- Páginas: 530
- Fecha Publicación: 01/11/2008
- Nº Volúmenes: 1
- Idioma: Inglés