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Document Type: | Book |
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All Authors / Contributors: |
Richard A Guarino |
ISBN: | 9780824750411 0824750411 |
OCLC Number: | 55589671 |
Description: | xiv, 635 pages : illustrations ; 24 cm. |
Contents: | 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. |
Series Title: | Drugs and the pharmaceutical sciences, v. 139. |
Responsibility: | edited by Richard A. Guarino. |
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