New Drug Approval Process 3rd Edition

Drug development teams; non-clinical drug development - pharmacology, drug metabolism and toxicology; the investigational new drug application and the investigator's brochure; general considerations of the NDA; specific requirements, content and format of an NDA; the biological license application (BLA); chemistry, manufacturing, and control requirements of the NDA and ANDA; clinical research protocols; adverse reactions and interactions of drugs; Institutional Review Board/Independent Ethics Committee and informed consent - protecting subjects throughout the clinical research process; statistical and data management collaboration in clinical research; the management of clinical studies; obligations of the investigator, sponsor and monitor; preparing for FDA inspections - manufacturing sites; quality assurance; orphan drugs; clinical development and regulations for OTC drugs; industry and FDA liaison; data presentation for FDA submissions - text and tabular exposition; the computer world in new drug development; working with a CRO; the evolving SMO in the US.