Full Description
The book reviews clinical trial methodology as it pertains to drug development in psychiatry. The reader will understand the process of drug development in psychiatry from discovery through marketing with the help of clinically relevant examples. The reader will appreciate the history of drug development in psychiatry dating back to the era of serendipitous discovery and culminating in an era of new and highly focused targets. Readers will understand how drug development in psychiatry has changed and adapted with the discovery of novel mechanism of action drugs. Novel drugs and disease targets have changed the way developers and regulatory agencies think about clinical trial methodology.
The book elucidates how biomarkers, genetics and advances in neuroscience and neuroimaging have influenced drug development approaches, which will ultimately change the practice of psychiatry. The book will be broken down into the following sections:
a. Prior to the 1960s - Drug discovery by chance observation
b. The last 50 years - refined targeting of CNS drugs without the discovery of mechanistically new drugs
c. The future - the discovery and development of mechanistically new drugs. The examination of new targets, genetics and biomarkers.
Contents
Drug Development in Psychiatry: The Long and Winding Road from Chance Discovery to Rational Development.- The History of Drug Development in Psychiatry: A Lesson in Serendipity.- The Evolving Role of Animal Models in the Discovery and Development of Novel Treatments for Psychiatric Disorders.- Discovery and Development of Monoamine Transporter Ligands.- Drug Development for New Psychiatric Drug Therapies.- Post-Approval Research in Drug Development: Priorities and Practices.- Discovery of new transmitter systems and hence new drug targets.- Reverse engineering drugs.- Back to the Future of Neuropsychopharmacology.- Targeted Treatments for Fragile X Syndrome.- The Difficult Path to the Discovery of Novel Treatments in Psychiatric Disorders Diseases.- Biomarkers in Psychiatric Drug Development: From Precision Medicine to Novel Therapeutics.- The role of fMRI in drug development: an update.- Monoamine Oxidase B (MAO-B): A Target for Rational Drug Development in Schizophrenia Using PET Imaging as an Example.- Genomics in Treatment Development.- Increased Inflammation and Treatment of Depression: from Resistance to Reuse, Repurposing and Redesign.- Experimental medicine approaches in early phase CNS drug development.
