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Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses. At an annual growth rate of 23%, industry investment in postmarketing research is expected to top $12 billion in 2007.
Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses. At an annual growth rate of 23%, industry investment in postmarketing research is expected to top $12 billion in 2007.
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Phase IV trials involve the safety surveillance and ongoing technical support of a drug after it receives permission to be sold. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses. At an annual growth rate of 23%, industry investment in postmarketing research is expected to top $12 billion in 2007.
Droits d'auteur :
Attribution Non-Commercial (BY-NC)
Formats disponibles
Téléchargez comme DOC, PDF, TXT ou lisez en ligne sur Scribd
Title: In-depth analysis of phase four in pharma and post
marketing surveillance .
Scope:- Phase IV trial is also known as Post Marketing Surveillance Trial.
Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Harmful effects discovered by Phase IV trials may result in a drug being no longer sold, or restricted to certain uses: recent examples involve cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).
Justification:- Phase 4 is the fastest-growing area of clinical research
today. At an annual growth rate of 23%, industry investment in post- marketing research is expected to top $12 billion in 2007. Post-marketing research is an important element of commercialization that enables companies to expand existing markets, enter new markets, develop and deliver messaging that directly compares their products with the competition, and secure a niche position in crowded markets.