New drug approval process : accelerating global registrations / edited by- Guarino, Richard A.
Material type: TextLanguage: English Series: Drugs and the pharmaceutical sciencesPublication details: New York : Marcel Dekker, Inc., c2004. Edition: 4th edDescription: xiv, 635 p. : figures, tables, ill. ; 22 cmISBN: 0824750411 Hard bound; 9780824750411Subject(s): Drug Approval | Drug Evaluation | Clinical Trials as TopicDDC classification: 615.10973 Online resources: WorldCat details | Ebook FulltextItem type | Current library | Collection | Call number | Copy number | Status | Date due | Barcode | Item holds |
---|---|---|---|---|---|---|---|---|
E-Book | Dr. S. R. Lasker Library, EWU E-book | Non-fiction | 615.10973 NEW 2004 (Browse shelf(Opens below)) | Not for loan | ||||
Text | Dr. S. R. Lasker Library, EWU Reserve Section | Non-fiction | 615.10973 NEW 2004 (Browse shelf(Opens below)) | C-1 | Not For Loan | 19384 | ||
Text | Dr. S. R. Lasker Library, EWU Circulation Section | Non-fiction | 615.10973 NEW 2004 (Browse shelf(Opens below)) | C-2 | Available | 19385 | ||
Text | Dr. S. R. Lasker Library, EWU Circulation Section | Non-fiction | 615.10973 NEW 2004 (Browse shelf(Opens below)) | C-3 | Available | 19386 |
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
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.
Pharmacy
Abdul Gani
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