New drug approval process : accelerating global registrations / edited by- Guarino, Richard A. - 4th ed. - New York : Marcel Dekker, Inc., c2004. - xiv, 635 p. : figures, tables, ill. ; 22 cm. - Drugs and the pharmaceutical sciences. .

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.



0824750411 Hard bound 9780824750411


Drug Approval
Drug Evaluation
Clinical Trials as Topic

615.10973 / NEW 2004

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