TITLE

Post-marketing phase IV studies create opportunities for clinical research sites

PUB. DATE
August 2007
SOURCE
Clinical Trials Administrator;Aug2007, Vol. 5 Issue 8, p85
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports that the U.S. Food and Drug Administration (FDA), pharmaceutical companies, and clinical research sites all have vested interest in post-marketing studies, but problems remain despite buy-in for this process and its recent growth. According to Christopher Milne, associate director of the Tufts Center for the Study of Drug Development in Boston, Massachusetts, post-marketing studies have had problems with delays, variable costs, and little improvement in product profile.
ACCESSION #
25887263

 

Related Articles

  • FDA 'Path' to streamline drug development could improve quality. Walker, Tracey // Managed Healthcare Executive;May2006, Vol. 16 Issue 5, p10 

    The article presents the Critical Path initiative of the U.S. Food and Drug Administration (FDA) that aims to develop and advance medical product development. The initiative is designed to enhance the scientific assessment tests used to evaluate investigational medical products. The FDA is...

  • Benchmarking biotech and pharmaceutical product development. Drakeman, Donald L // Nature Biotechnology;Jul2014, Vol. 32 Issue 7, p621 

    The author reflects on the report of the U.S. Food and Drug Administration (FDA) regarding the growth in the pharmaceutical firms and developments and commercial sales of pharmaceutical products in the U.S. from 1998 to 2012. Topics include improvement in the safety measures of the drugs,...

  • Sun Pharmaceutical wins FDA approval for cancer drug's ANDA.  // PharmaWatch: Cancer;Nov2008, Vol. 7 Issue 11, p11 

    The article reports on the approval of FDA for Sun Pharmaceuticals Industries Ltd.'s carboplatin injection. It states that these injections are indicated as initial and secondary therapy in patients with advanced ovarian carcinoma. It notes that the generic versions of carboplatin are...

  • Oral Drug Delivery Market to 2017 - Patients to See Innovations in the Market.  // Biomedical Market Newsletter;5/25/2012, Vol. 21, p1 

    The article informs that Research & Markets Ltd. has announced the inclusion of "Oral Drug Delivery Market to 2017 - Patients to See Innovations in the Market" report to their offering. The report mentions about encouragement of pharmaceutical companies for the reformulation of drugs owing to...

  • Defining the Similarity of Dissolution Profiles Using Hotelling's T[sup2] Statistic. Saranadasa, Hewa // Pharmaceutical Technology Asia;Apr2002, p26 

    Describes a method for assessing the similarity of dissolution profiles through Hotelling's T² statistic. Comparison of the method to the f[sub2] criterion recommended by the U.S. Food and Drug Administration's guidance on dissolution testing; Results of applications of the methods;...

  • FDA Champions Risk-Based Analysis for 21 CFR Part 11. Keating, Sean // Drug Discovery & Development;Jun2003, Vol. 6 Issue 6, p59 

    Focuses on the United States Food and Drug Administration's (FDA) 21 CFR Part 11 regulation issued March 1997 which provides guidelines on drug development for pharmaceutical companies. Problems associated with pharmaceutical industry's compliance to guidelines; Provisions; Compliance problems...

  • A year of opportunities. Tosh, Mark // Medical Marketing & Media;Jan2003, Vol. 38 Issue 1, p3 

    Presents an overview of articles found in the January 2003 issue of the journal 'Medical Marketing & Media.' Prediction on the backlog of the New Drug Application of the U.S. Food and Drug Administration; List of late-stage development drug products; Techniques in repairing damage caused by...

  • Big Spenders Still Seek Approvals.  // Pharmaceutical Executive;Mar2005, Vol. 25 Issue 3, p34 

    Focuses on the efforts of Big Pharma in seeking approvals for new molecular entities (NME) from the U.S. Food and Drugs Administration (FDA) in 2004. Number of NME approved by the FDA in 2004; Amount spent by Big Pharma in its drug research and development projects; Condition of the research and...

  • Better Future for Pharma/Biotech? Agres, Ted // Drug Discovery & Development;Dec2002, Vol. 5 Issue 11, p15 

    Discusses the prospects of pharmaceutical companies in the United States for 2003. Problems encountered by the industry during 2002; Pending approvals for biotech medicines from the U.S. Food and Drug Administration (FDA); Average cost to bring a new drug to the market; Factors influencing the...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics