Information Library
Regulatory
To learn more about a particular aspect of Quintiles’ pharma services, biotech development or drug commercialization services, select a topic at left. If you’ve already specified a choice, you may narrow your search by selecting additional categories in any order. For example, for information on oncology drug development, start by selecting oncology. Then you can narrow your search to Central Lab, News Releases and Europe.
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The New Health Clinical Brochure
August 31, 2010
Japanese version available for download. -
RAPS 2010
October 24 - October 27, 2010
Quintiles will be exhibiting and participating at the annual Regulatory Affairs Professionals Society conference, October 24-27 in San Jose, CA. -
Managing Pharmacovigilance as a Business
July 28, 2010
The three steps required to develop a strategic approach to global capacity management. -
Communication Strategies for Risk Minimization
July 12, 2010
In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product -
Generic Drug Approvals in the US Prior to the Hatch-Waxman Act
July 12, 2010
It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were -
The Evolution of Oncologic Drug Development
July 8, 2010
Despite a doubling in the number of candidates in the cancer drug pipeline from 1990 through 2006, the overall US approval rate for cancer drugs -
FDA Requirements for Clinical Studies in Pediatric Patients
July 7, 2010
Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric -
On the Origin of the Animal Rule
July 7, 2010
New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -
Key Challenges to US Topical Ocular Drug Development
July 7, 2010
This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development. An understanding of ophthalmology -
Follow-on Biologics in the EU & US
July 7, 2010
Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to
