Τόμος 19 (2005) – Τεύχος 1 – Άρθρο 5 – Επιθεώρηση Κλινικής Φαρμακολογίας και Φαρμακοκινητικής-Διεθνής Έκδοση – Volume 19 (2005) – Issue 1 – Article 5 – Epitheorese Klinikes Farmakologias και Farmakokinetikes-International Edition

 

Title New drug discovery and development: a drug regulatory and economic approach
Author Helen Plessa

School of Business Administration and Economics, Technological Educational Institution of Athens, Athens, Greece

Citation Plessa, H.: New drug discovery and development: a drug regulatory and economic approach, Epitheorese Klin. Farmakol. Farmakokinet. 19(1): 27-30 (2005)
Publication Date Received for publication: 20 January 2005

 Accepted for publication: 5 February 2005

Full Text Language English
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Keywords Pharmaceutical industry, worldwide, European, new drugs, stages of development, economic aspects, regulatory data protection.
Other Terms review article
Introduction It is self-evident that patients have increasingly come to expect new and better therapies, including drugs, that will help them to live longer, better quality and more productive lives than ever before. Regulatory authorities and pharmaceutical industries believe that the intensive research can offer patients tremendous opportunities and choices in their personal healthcare and well-being. In this complex of Regulatory authorities and pharmaceutical industries, drug regulation reflects the growing involvement of European Union and governments in most countries to ensure increasing degree of efficacy and safety in marketed medicinal agents. […]
References 1.    European Federation of Pharmaceutical Industries and Associations: Medicines for Mankind: Today’s research, tomorrow’s cures, www.efpia.org

2.    McKillop T.: Europe must do more to encourage innovation for benefit of patients. Annual Meeting of the European Federation of Pharmaceutical Industries and Associations, 20-28 May, Athens, Greece, 2003

3.    Dimitriou D.F.: Commercialising academic research: The challenges, the world-wide pharmaceutical and biotechnology industry developments and the need for partnering. Rev. Clin. Pharmacol. Pharmacokinet. Int. Edit. 17 : 78-79 (2003)

4.    Koolwijk P.: Stimulation of innovative biotechnological research by companies in the Netherlands. Role of government and the independent knowledge institutes. Epitheor. Klin. Farmakol. Farmakokinet. 23: 12-13 (2005)

5.    Dimitriou D.F.: New drug discovery and development: A lottery perspective. 5th Conference of Medicinal Chemistry: Drug discovery and design. March 11-13, Abstract Book, University of Patras, Patra, Greece

6.    Marselos M.: Approval procedures in relation to risk factors for new drugs in the European Union. Epitheor. Klin. Farmakol. Farmakokinet. 21: 22-28 (2003)

7.    Nies S.A., Spielberg S.P.: Principles of Therapeutics. In: Goodman and Gilman’s The Pharmacological Basis of Therapeutics. Ninth Edition, pp. 55-58, McGraw-Hill, New York, 1996

8.    Plessa H.: La politique française de la promotion des médicaments génériques. Quelles sont les reactions des acteurs de l’îndistrie pharmaceutique. Rev. Clin. Pharmacol. Pharmacokinet. Int, Edit. 12: 67-86 (1998)

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