Home

WorldCat Home About WorldCat Help

Search

Search for Library Items Search for Lists Search for Contacts Search for a Library

Create lists, bibliographies and reviews: or

Cite/Export

Cite/Export

Copy a citation

APA (6th ed.)

Chicago (Author-Date, 15th ed.)

Harvard (18th ed.)

MLA (7th ed.)

Turabian (6th ed.)

Export a citation
Export to RefWorks Export to EndNote / Reference Manager Export to EasyBib
Export to EndNote / Reference Manager(non-Latin) Cancel
Note: Citations are based on reference standards. However, formatting rules can vary widely between applications and fields of interest or study. The specific requirements or preferences of your reviewing publisher, classroom teacher, institution or organization should be applied.
Print
E-mail

E-mail

All fields are required.

The E-mail Address(es) field is required. Please enter recipient e-mail address(es).

The E-mail Address(es) you entered is(are) not in a valid format. Please re-enter recipient e-mail address(es).

You may send this item to up to five recipients.
Enter recipient e-mail address(es): Separate up to five addresses with commas (,)
The name field is required. Please enter your name.
Enter your name: Subject:
The E-mail message field is required. Please enter the message.
E-mail Message: I thought you might be interested in this item at http://www.worldcat.org/oclc/55589671 Title: New drug approval process : accelerating global registrations Author: Richard A Guarino Publisher: New York : M. Dekker, ©2004. ISBN/ISSN: 9780824750411 0824750411 OCLC:55589671

Please verify that you are not a robot.

Cancel
Share
Permalink

Permalink

Copy this URL to link to this page:

Checking...

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
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 Read more...
Subjects	Drug approval -- United States. Drugs -- Testing -- Standards. Drugs -- Testing -- Government policy -- United States. View all subjects
More like this	Similar Items

Find a copy in the library

Finding libraries that hold this item...

Details

Document Type:	Book
All Authors / Contributors:	Richard A Guarino Find more information about:
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.

You:	Sign In \| Register \| My WorldCat \| My Lists \| My Watchlist \| My Saved Searches
WorldCat:	Home \| About \| Help \| Search

New drug approval process : accelerating global registrations

Find a copy in the library

Details

Reviews

Similar Items

Related Subjects:(18)