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New drug approval process : accelerating global registrations / edited by- Guarino, Richard A.

Contributor(s): Guarino, Richard A.
Material type: TextTextSeries: Drugs and the pharmaceutical sciences. Publisher: New York : Marcel Dekker, Inc., c2004Edition: 4th ed.Description: xiv, 635 p. : figures, tables, ill. ; 22 cm.ISBN: 0824750411 Hard bound; 9780824750411.Subject(s): Drug Approval | Drug Evaluation | Clinical Trials as TopicDDC classification: 615.10973 Online resources: WorldCat details | Ebook Fulltext
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. Table of contents
Summary: 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.
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Item type Current location Collection Call number Copy number Status Date due Barcode Item holds
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Non-fiction 615.10973 NEW 2004 (Browse shelf) Not for loan
Text Text EWU Library
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Non-fiction 615.10973 NEW 2004 (Browse shelf) C-1 Not For Loan 19384
Text Text EWU Library
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Non-fiction 615.10973 NEW 2004 (Browse shelf) C-2 Available 19385
Text Text EWU Library
Circulation Section
Non-fiction 615.10973 NEW 2004 (Browse shelf) C-3 Available 19386
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615.1076 COM 2010 Comprehensive pharmacy review / 615.1076 LIP 2012 Lippincott's illustrated reviews : 615.1076 MCQ 2009 MCQ's in pharmacy practice / 615.10973 NEW 2004 New drug approval process : 615.11 EUR 2004 European pharmacopoeia / 615.1401513 ANP 2010 Pharmaceutical calculations / 615.15 KHF 2003 Financing large projects :

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. Table of contents

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

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