The Process of New Drug Discovery and Development, 2nd Edition

Overview of Drug Discovery and Development. Organizational Formats, Definition of Targets, and Patent Considerations. Defining the Actual Research Approach to the New Drug Substance. Screening and Biological Evaluation Systems. Toxicology and Pathology. Absorption, Distribution, Metabolism and Excretion Studies. Pharmaceutics. Clinical Investigations. Drug Regulatory Operations. Biometrics and Computer Sciences. Late Stage and Process Development Activities. Worldwide Drug Development. Biotechnology. The Need for Animals in Biomedical Research. Epilogue. References. Index.