New drug approval process : accelerating global registrations (Book, 2004) []
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New drug approval process : accelerating global registrations

New drug approval process : accelerating global registrations

Author: Richard A Guarino
Publisher: New York : M. Dekker, ©2004.
Series: Drugs and the pharmaceutical sciences, v. 139.
Edition/Format:   Print book : English : 4th edView all editions and formats

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  Read more...

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Document Type: Book
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 --
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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