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New drug approval process [electronic resource] : the global challenge / edited by Richard A. Guarino.

Contributor(s): Guarino, Richard A, 1935-.
Material type: TextTextSeries: Drugs and the pharmaceutical sciences: v. 100.Publisher: New York : Marcel Dekker, c2000Edition: 3rd ed.General Notes: Available through the EBSCO e-book Collection, which can be found on the Davenport University Library database page.Bibliography: Includes bibliographical references and index.Description: 1 online resource (xxxiii, 471 p.) : ill.ISBN: 0585231362 (electronic bk.); 9780585231365 (electronic bk.).Subject(s): Drugs -- Testing -- Standards | Drugs -- Testing -- Government policy -- United States | New products -- Government policy -- United States | Clinical trials -- Standards -- United StatesGenre/Form: Electronic books DDC classification: 363.19/46/0973 Online resources: Access full-text materials at no charge:
Contents:
Regulatory aspects of new drug development -- Clinical research development -- Good clinical practices -- The orphan drug and the Rx to OTC switch -- Effective methodology is expediting NDA approval.
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Includes bibliographical references and index.

Available through the EBSCO e-book Collection, which can be found on the Davenport University Library database page.

Regulatory aspects of new drug development -- Clinical research development -- Good clinical practices -- The orphan drug and the Rx to OTC switch -- Effective methodology is expediting NDA approval.

Description based on print version record.

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