Princeton University Library Catalog

New drug development : a regulatory overview / by Mark Mathieu ; with contributions from Christopher-Paul Milne.

Mathieu, Mark P. [Browse]
Waltham, MA : PAREXEL International Corp., c2008.
Rev. 8th ed.
362 p. : ill. ; 28 cm.
Summary note:
"Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: how the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements; how the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes; how CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process; how the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions; and which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process."--Publisher's description.
Bibliographic references:
Includes bibliographical references.
An introduction to the U.S. new drug approval process -- Nonclinical drug testing -- The IND -- CDER and the IND review process -- The clinical development of new drugs -- Good clinical practice (GCP) -- The new drug application (NDA) -- The NDA review process -- The FDA's priority review policy -- Advisory committees and the drug approval process -- Beyond approval: postmarketing drug manufacturer regulatory responsibilities -- The supplemental NDA and postapproval changes to marketed drugs -- The FDA's orphan drug development program -- CDER's bioresearch monitoring program -- Accelerated drug approval/expanded access programs -- The pediatric studies initiative.
  • 9781882615858
  • 1882615859
Related name:
C - S