TY - BOOK AU - Guarino,Richard A. TI - New drug approval process: accelerating global registrations SN - 0824750411 Hard bound U1 - 615.10973 22 PY - 2004/// CY - New York PB - Marcel Dekker, Inc. KW - Drug Approval KW - Drug Evaluation KW - Clinical Trials as Topic N1 - Includes Bibliographical References and Index; Part I : Regulatory practices and procedures of new drug, biologic and device development -- Drug development teams -- Nonclinical drug development -- The investigational new drug application and the investigator's brochure -- General considerations of the new drug application -- The new drug application, content and format -- Abbreviated and supplemental new drug applications -- The biologics license application -- Device legislation and application -- Orphan drugs -- Part II : Clinical research development -- Adverse experiences, adverse reactions, interactions of drugs -- Biostatistics in pharmaceutical product development -- Industry and FDA liasion -- Part III : Specific aspects in the process of new product submissions -- Chemistry, manufacturing, and control requirements of the NDA and ANDA -- Data presentation for FDA submissions -- Preparing for FDA inspections -- Technology change -- The common technical document for the registration of pharmaceutical for human use -- Part IV : Global applications of good clinical practices -- Obligations of the investigator, sponsor, monitor -- Instituitional review board -- Quality assurance -- Managing clinical trials -- The European union directive on good clinical parctice in clinical trials -- HIPAA -- Part V : Effective and new methodologies in expediting new product approvals in the US and European union -- Working with a CRO -- The evolving SMO in the US -- Accelerating new product approvals; TOC; Pharmacy N2 - Clarifying how to develop and market new drugs efficiently and economically for global markets, this text covers the emphasis on over-the-counter drugs in the long-range plans of many companies and discusses licence applications review boards UR - http://www.worldcat.org/title/new-drug-approval-process-accelerating-global-registrations/oclc/55589671&referer=brief_results UR - http://lib.ewubd.edu/ebook/5195 ER -