Academic literature on the topic 'Pharmaceutical biotechnology industry'

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Journal articles on the topic "Pharmaceutical biotechnology industry"

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Evens, Ronald P. "The Biotechnology Industry." Journal of Pharmacy Practice 11, no. 1 (February 1998): 13–18. http://dx.doi.org/10.1177/089719009801100104.

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Growth and change are the hallmarks of the developing biotechnology industry. Since the first approval of a biological product in 1982, over 40 biologicals, many of them medical breakthroughs, have been brought to market. The majority of biotechnology companies focus on developing human therapeutic agents, but about 25 percent of biotechnology companies focus on the diagnostic area, using monoclonal antibody technology, polymerase chain reaction (PCR) technology, and genetics to provide advances in diagnosis and disease monitoring. Structurally, few biotechnology firms are fully integrated companies with full capabilities in research, development, manufacturing, and sales and marketing. Many pursue strategic alliances with other companies to enhance their capabilities in research, development, and sales and marketing. Research alliances between companies and universities are also frequently used to enhance research capabilities. As the industry has matured, consolidation has occurred, with major pharmaceutical companies purchasing biotechnology companies and biotechnology companies merging to expand their capabilities. Research investment, as a percentage of gross sales, continues to be very high for biotechnology companies compared with traditional pharmaceutical companies. The cost of drug development is high, but the probability of approval appears to be somewhat better in the biotechnology field compared with traditional pharmaceuticals. Today, the biotechnology product pipeline is rich, with between 400 to 700 products in various stages of clinical development. Technology developments beyond recombinant DNA technology and monoclonal antibodies, such as antisense, genomics, and combinatorial chemistry, will lead to additional therapeutic and diagnostic breakthroughs.
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Rubin, Suzie. "Biotechnology and the Pharmaceutical Industry." Cancer Investigation 11, no. 4 (January 1993): 451–57. http://dx.doi.org/10.3109/07357909309018876.

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Dibner, Mark D. "The pharmaceutical industry: impacts of biotechnology." Trends in Pharmacological Sciences 6 (January 1985): 343–46. http://dx.doi.org/10.1016/0165-6147(85)90158-0.

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de la Cueva-Méndez, Guillermo, and Dror Seliktar. "Editorial overview: Pharmaceutical biotechnology: Expanding horizons for pharmaceutical biotechnology in industry and academia." Current Opinion in Biotechnology 35 (December 2015): iv—vi. http://dx.doi.org/10.1016/j.copbio.2015.09.002.

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Gottinger, Hans-Werner, and Celia L. Umali. "The evolution of the pharmaceutical-biotechnology industry." Business History 50, no. 5 (August 5, 2008): 583–601. http://dx.doi.org/10.1080/00076790802246020.

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Piachaud, Bianca S., and Matthew G. Lynas. "The biotechnology revolution: implications for the pharmaceutical industry." International Journal of Biotechnology 3, no. 3/4 (2001): 350. http://dx.doi.org/10.1504/ijbt.2001.000170.

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Dibner, M. D., and P. B. Timmermans. "Biotechnology and the pharmaceutical industry. New cardiovascular drugs." Hypertension 8, no. 11 (November 1986): 965–70. http://dx.doi.org/10.1161/01.hyp.8.11.965.

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Löffler, A. "Trends in biotechnology: Implications for the pharmaceutical industry." Journal of Medical Marketing 2, no. 4 (September 1, 2002): 345–48. http://dx.doi.org/10.1057/palgrave.jmm.5040092.

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Bingham, Alph, and Sean Ekins. "Competitive collaboration in the pharmaceutical and biotechnology industry." Drug Discovery Today 14, no. 23-24 (December 2009): 1079–81. http://dx.doi.org/10.1016/j.drudis.2009.10.003.

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Piascik, Peggy, and Thomas S. Foster. "The Biotechnology Industry: Consolidating for Survival." Journal of the American Pharmaceutical Association (1996) 36, no. 4 (April 1996): 229–30. http://dx.doi.org/10.1016/s1086-5802(16)30057-2.

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Dissertations / Theses on the topic "Pharmaceutical biotechnology industry"

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Alimov, Azizjon. "Innovations, real options, risk and return : evidence from the pharmaceutical and biotechnology industries /." view abstract or download file of text, 2007. http://proquest.umi.com/pqdweb?did=1421619401&sid=1&Fmt=2&clientId=11238&RQT=309&VName=PQD.

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Thesis (Ph. D.)--University of Oregon, 2007.
Typescript. Includes vita and abstract. Includes bibliographical references (leaves 109-114). Also available for download via the World Wide Web; free to University of Oregon users.
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Nel, Izak Bartholomeus Jacques. "The relationship between global pharmaceutical companies and the biotechnology industry in South Africa : implications for an emerging biotechnology industry in South Africa." Thesis, Stellenbosch : Stellenbosch University, 2003. http://hdl.handle.net/10019.1/53672.

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Mini-study project (MBA)--University of Stellenbosch, 2003.
ENGLISH ABSTRACT: This report reviews the global and South African pharmaceutical and biotechnology industries and provides an overview of the changes taking place within these two industries. It highlights the impact this relationship will have on a developing South African biotechnology industry. Since the 1980s the pharmaceutical industry has experienced phenomenal growth in sales and profits. By the mid 1990s drug sales exceeded USD250 billion. Today the pharmaceutical industry is dominated by multi-national corporations with extensive R&D budgets, widespread use of trademarks and patents and complex commercial process technology. However they face threats from depleted product pipelines, patent expiry on billion dollar drug products, generic competition, increases in drug approval times, costs and price pressures. The entrepreneurial biotechnology industry promises to solve a number of the pharmaceutical industry's problems. In recent years biotechnology companies proved more effective in the development of new molecular entities. They promise individualised therapeutics, novel and more efficacious drug discovery and development of preventative treatments. However the decrease in equity financing after 2001 left almost 40% of biotechnology companies with less than 1 year of R&D funding. The industry experienced losses again in 2002 and the world is divided over the ethical, environmental and economic implications of biotechnological applications. The biotechnology and pharmaceutical industries have a symbiotic but antagonistic relationship. The change in this relationship will hugely affect South Africa's ideals of developing a biotechnology industry. Various diseases plague South Africa including HIV/AIDS, TB, obesity, diabetes, hypertension and infective diseases. These diseases will have a huge impact on South Africa's society. Yet only 10% of global R&D funding is committed to third world diseases and existing drugs and treatments are either not effective or too expensive for developing countries. It is in this situation that biotechnology and the development of a biotechnology industry could playa major role in alleviating South Africa's health burden. South Africa is already capable in first generation biotechnology, but third generation applications holds the most promise. Developing countries face various obstacles and challenges, but all boast well for South Africa. The government has committed R400 million (over a three year period) to utilize South Africa's biotechnology potential. Further, the country has highly skilled researchers, indigenous plant and animal species, a diverse population and a favorable exchange rate (low R&D costs).
AFRIKAANSE OPSOMMING: Die projek ondersoek beide die globale en Suid Afrikaanse farmaseutiese en biotegnologie industrieë. Verder word die veranderinge wat plaasvind in die industrieë onder die soeklig geplaas. Die projek beklemtoon die impak wat die verhouding sal hê op 'n ontwikkelende biotegnologie industrie in Suid Afrika. Die farmaseutiese industrie het sedert die 1980s dubbel syfer groei getoon in omsete en wins. Teen die middel 90's het verkope van farmaseutiese middels US$250 miljard wêreldwyd oorskry. Vandag word die farmaseutiese industrie oorheers deur multi-nasionale korporasies met omvattende navorsing en ontwikkelings begrotings, algemene gebruik van handelsmerkte, patente en komplekse proses-tegnologieë. Ten spyte hiervan word die industrie bedreig deur leë produksie-lyne, verval van patente, miljard dollar farmaseutiese produkte, generiese kompetisie, verlengde produk-goedkeurings periodes en prys-mededinging. Die biotegnologie industrie met sy innoveerende eienskappe beloof om verskeie van die farmaseutiese industrie se probleme op te los. Onlangs het biotegnologie maatskappye getoon dat hulle meer effektief is in die ontwikkeling van nuwe molekulêre eenhede. Biotegnologie beloof nuwe en meer effektiewe produk-ontwikkeling asook beter individuele terapieë en voorkomende behandelings. Die industrie staar finansiële krisisse in die gesig. Slegs 40% van biotegnologie maatskappye het voldoende navorsing en ontwikkelings-kapitaal tot 2004. Dit is hoofsaaklik as gevolg van 'n afname in eienaars-finansiering na 2001. Die industrie as 'n geheel het weereens 'n verlies gelei in 2002 en die wêreld is verdeeld oor die etiese, omgewings en ekonomiese implikasie van biotegnologiese toepassings. Die biotegnologie en farmaseutiese industrieë het 'n simbiotiese maar tog vyandige verhouding. 'n Verandering in die verhouding gaan Suid Afrika se ideale om 'n biotegnologie industrie te skep grootliks beïnvloed. Suid Afrika gaan gebuk onder verskeie siektes insluitende MIVNIGS, TB, vetsugtigheid, diabetes, hipertensie en infeksie siektes. Hierdie siektes het 'n groot impak op Suid Afrika se samelewing. Tog word slegs 10% van die globale navorsings en ontwikkelingsfondse aangewend om 'n oplossing te vind vir derdewêreld siektes. Verder is bestaande produkte en behandelings oneffektief of onbekostigbaar vir ontwikkelde lande. Dit is in sulke gevalle waar biotegnologie en die ontwikkeling van 'n biotegnologie industrie 'n groot rol kan speel in die verligting van Suid Afrika se gesondheids-las. Suid Afrika is vaardig in eerste-generasie biotegnologie, maar wêreld wyd hou derde generasie biotegnologie die meeste belofte in. Die tegnologie is tot op hede onderbenut in Suid Afrika. Ontwikkelende lande staar verskeie uitdagings in die gesig, maar Suid Afrika het talle sterk punte. Die regering het R400 miljoen (oor 'n drie jaar periode) beskikbaar gestel vir die ontwikkeling van Suid Afrika se biotegnologie potensiaal. Die land beskik ook oor navorsers van hoogstande gehalte, onbenutte inheemse plante en dier spesies, 'n diverse populasie en 'n gunstige wisselkoers (lae navorsings en ontwikkelings kostes).
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Gretton, Linda Burak. "The rhetorical helix of the biotechnology and pharmaceutical industries strategies of transformation though definition, description and ingratiation /." Greensboro, N.C. : University of North Carolina at Greensboro, 2007. http://libres.uncg.edu/edocs/etd/1435/umi-uncg-1435.pdf.

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Thesis (Ph.D.)--University of North Carolina at Greensboro, 2007.
Title from PDF t.p. (viewed Oct. 22, 2007). Directed by Nancy Myers; submitted to the Dept. of English. Includes bibliographical references (p. 209-228).
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Vazquez, Toro Guillermo J. "Patent Quality And Company Performance| A Sample within the USA Biotechnology and Pharmaceutical Industry." Thesis, Inter-American University of Puerto Rico (Puerto Rico), 2014. http://pqdtopen.proquest.com/#viewpdf?dispub=3577982.

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This Dissertation investigates the relationship between patent quality and company performance for a sample from the US Biotechnology and Pharmaceutical Industry. The methodology devised comprehensively examines patent worth (patent’s references), patent protection (claims and family patents) and patent quality (references, claims and family patents) to determine their implications on firm leverage (SE, TA), profits (ROE, ROA), and market value (B/M, MCap). The selected sample comprises 1,536 companies, and 285,000 patents from 1999 to 2009. The results show that total revenue just responds to changes in R&D; intensity, and patenting intensity. A 10 percent increase in patent value results in a corresponding increase rate on the market capitalization index for the full sample and a 14 percent increase for the chemicals and allied products group (SIC 28). Increases (10%) in patent protection and quality present average increases of 15 percent on market capitalization for the full sample and 8 percent for the chemicals and allied products group (SIC 28). The medical devices group (SIC 38) results suggest that Mcap increases 10 percent by the same increase in patent value index. Patent protection and quality increases (10%) suggest an average 8 percent increase in Mcap. Results suggest that profits, leverage and market indices respond differently to 10 percent increases in patent value, patent protections and patent quality. The aforementioned effects suggest that the qualitative indexes follow company related market activities and business valuations for the chemical and allied products, and medical devices industrial sectors.

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Otieno, Charles J. "Analysis of strategic alliance deals in the global CNS industry /." Burnaby B.C. : Simon Fraser University, 2006. http://ir.lib.sfu.ca/handle/1892/2741.

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Houston, Chad Allen. "Biotechnology valuation an examination of the drug development pipeline and board of director composition /." View electronic thesis (PDF), 2009. http://dl.uncw.edu/etd/2009-3/r1/houstonc/chadhouston.pdf.

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Pavúk, Šimon. "Aplikácia investičnej analýzy na biotechnologicko- farmaceutický sektor." Master's thesis, Vysoká škola ekonomická v Praze, 2010. http://www.nusl.cz/ntk/nusl-76239.

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The principal aim of this thesis is to describe methods of fundamental analysis of three major companies from sectors of Biotechnology and Pharmaceuticals, namely Johnson & Johnson, Pfizer and Amgen. Among used methods we are able to find 2 -- stage discounted cashlow models Free-cashflow-to-equity FCFE and Free-cashflow-to-firm FCFF, Gordon's dividend discount model a relative valuation methods using P/E, P/BV and P/S. Descriptive part of this thesis describes legal and regulatory environment, which has significant impact on the development process of new innovative drugs and therapies. Further it sets investment recommendations and looks closer at investment opportunities in biotechnological companies.
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Possnert, Oliver, and Adam Schön. "A case study research of asymmetrical relationshipsbetween service providers and emerging companieswithin the healthcare industry." Thesis, Uppsala universitet, Institutionen för biologisk grundutbildning, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-353334.

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This master thesis report aims to highlight the importance ofinterorganizational relationships between experienced serviceproviders and emerging biopharmaceutical (EBP) companies within theSwedish healthcare industry. A shift in innovation strategiesregarding new pharmaceutical- and medical device products hasprompted a paradigm shift within a complex industry wherecollaborations between organisations has become increasinglycrucial. With a better understanding of how these companiesoperates, increased collaboration efforts could result in a fasterand more precise product development with new products reaching themarket improving the health for people around the world. In order toallow experienced service providers to enhance services towards EBPcompanies, a fundamental understanding of how decision makers withinthese EBP companies prefer to conduct relationships is needed. Wehave examined relationship preferences of EBP companies byconducting a qualitative case study through 14 interviews withdecision makers combined with a quantitative conjoint analysis.Eight factors was identified as important for when EBP companiesdecide to engage with a service provider: cost behavior,professional competence, adaptability, communication, personalrelationship, stability, EBP insight and size. The factorsadaptability, personal relationship, cost and size were used in theconjoint analysis to determine their relative importance which showthat adaptability and cost behavior was of the largest importance.With descriptions of each factor, we have provided a meaningfulguide to action of how to address these factors as a serviceprovider. The relationships is largely investigated as relationshipsbetween contract research organizations (as service providers) andEBP companies, but we have created a framework applicable forservice providers within the healthcare industry in general.
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Rybička, Miloš. "Analýza vybraných průmyslových sektorů v ČR a v SRN a komparace jejich konkurenceschopnosti jako podklad pro strategická rozhodování." Master's thesis, Vysoká škola ekonomická v Praze, 2012. http://www.nusl.cz/ntk/nusl-162363.

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The goal of this Masters Thesis is to analyze three selected industry sectors in the Czech Republic and in Germany. Concretely the industries in focus are engineering, motor vehicle manufacturing and finally pharmacy along with bio- and nanotechnology. Furthermore, factors limiting but also supporting the industry development are identified and described in the Thesis. In the Thesis, analytical instruments will be used, especially the SWOT analysis and benchmarking. The Thesis is mainly intended for managers, employees, consultants and all other direct or indirect interest groups of both Czech and German industry companies and their suppliers but also for potential investors who are deciding whether to enter a market in the CEE region.
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Larsen, David Mark. "The discursive function and the embedding of capitalism : British state policy on the pharmaceuticals and biotechnology sector." Thesis, University of Cambridge, 2010. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.608970.

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Books on the topic "Pharmaceutical biotechnology industry"

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Institute for Biotechnology Information (North Carolina Biotechnology Center), ed. Biotechnology industry guide. 2nd ed. Research Triangle Park, NC: The Institute, 1998.

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Institute for Biotechnology Information (North Carolina Biotechnology Center), ed. Biotechnology industry guide. Research Triangle Park, NC: The Institute, 1996.

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Welch, Mary F., Esther K. Palevsky, Diana E. Kole, and Dawn J. Trebec. Biotechnology pharmaceuticals. Cleveland: Freedonia Group, 2000.

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Misch, Kelly, and William D. Martineau. Biotechnology pharmaceuticals. Cleveland: Freedonia Group, 2000.

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J, Groves M., ed. Pharmaceutical biotechnology: Fundamentals and essentials. Buffalo Grove, Ill: Interpharm Press, 1992.

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Friedman, Rebecca L., and William D. Martineau. Biotechnology in pharmaceuticals. Cleveland: Freedonia Group, 1999.

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A, Crommelin D. J., Sindelar Robert D, and Meibohm Bernd, eds. Pharmaceutical biotechnology: Fundamentals and applications. 3rd ed. New York: Informa Healthcare USA, 2008.

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A, Crommelin D. J., Sindelar Robert D, and Meibohm Bernd, eds. Pharmaceutical biotechnology: Fundamentals and applications. 3rd ed. New York: Informa Healthcare, 2008.

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Alberta. Alberta Economic Development and Tourism. Technology Development Branch., ed. Alberta biotechnology and pharmaceutical directory. Edmonton, Alta: Alberta Economic Development and Tourism, Technology Development Branch, 1995.

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W, Crull Anna, and Business Communications Co, eds. Membrane microfilters in biotechnology/pharmaceutical separations. Norwalk, CT: Business Communications Co., 1993.

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Book chapters on the topic "Pharmaceutical biotechnology industry"

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Resnik, David B. "Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues." In Pharmaceutical Biotechnology, 269–84. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co. KGaA, 2012. http://dx.doi.org/10.1002/9783527632909.ch12.

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Resnik, David B. "Patents in the Pharmaceutical Biotechnology Industry: Legal and Ethical Issues." In Pharmaceutical Biotechnology, 187–200. Weinheim, FRG: Wiley-VCH Verlag GmbH & Co. KGaA, 2005. http://dx.doi.org/10.1002/3527602410.ch10.

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Kadow, John F., Nicholas A. Meanwell, Kyle J. Eastman, Kap-Sun Yeung, and Albert J. DelMonte. "Chemistry in the Pharmaceutical Industry." In Handbook of Industrial Chemistry and Biotechnology, 531–79. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-52287-6_8.

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Kadow, John F., Nicholas A. Meanwell, Kyle J. Eastman, Kap-Sun Yeung, and Joseph Payack. "Chemistry in the Pharmaceutical Industry." In Handbook of Industrial Chemistry and Biotechnology, 391–418. Boston, MA: Springer US, 2012. http://dx.doi.org/10.1007/978-1-4614-4259-2_11.

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Armenante, P. M., and A. C. Kirpekar. "Sterilization in the pharmaceutical and biotechnology industry." In Handbook of Downstream Processing, 261–308. Dordrecht: Springer Netherlands, 1997. http://dx.doi.org/10.1007/978-94-009-1563-3_11.

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Poindexter, Graham S., Yadagiri Pendri, Lawrence B. Snyder, Joseph P. Yevich, and Milind Deshpande. "Chemistry in the Pharmaceutical Industry." In Kent and Riegel’s Handbook of Industrial Chemistry and Biotechnology, 404–30. Boston, MA: Springer US, 2007. http://dx.doi.org/10.1007/978-0-387-27843-8_11.

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Giri, Sib Sankar. "Application of Microbial Biosurfactants in the Pharmaceutical Industry." In Environmental and Microbial Biotechnology, 251–69. Singapore: Springer Singapore, 2021. http://dx.doi.org/10.1007/978-981-15-6607-3_12.

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Boddu, Ramya Sree, and K. Divakar. "Metagenomic Insights into Environmental Microbiome and Their Application in Food/Pharmaceutical Industry." In Microbial Biotechnology, 23–38. Singapore: Springer Singapore, 2018. http://dx.doi.org/10.1007/978-981-10-7140-9_2.

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Lamottke, Kai, Nicole Feling, and Christian Haug. "Bicoll — The First Sino-German Biotechnology Company." In The Chemical and Pharmaceutical Industry in China, 189–98. Berlin, Heidelberg: Springer Berlin Heidelberg, 2005. http://dx.doi.org/10.1007/3-540-26561-9_16.

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Ramani, Shyama V., and M. S. Venkataramani. "Biotechnology and the Indian Pharmaceutical Industry Integration and Impact." In China and India, 181–206. London: Palgrave Macmillan UK, 1999. http://dx.doi.org/10.1007/978-0-333-99508-2_11.

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Conference papers on the topic "Pharmaceutical biotechnology industry"

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Shammout, Hadi, Tamás Sovány, and Krisztina Ludasi. "Laser applications in pharmaceutical industry." In V. Symposium of Young Researchers on Pharmaceutical Technology,Biotechnology and Regulatory Science. Szeged: Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Faculty of Pharmacy, 2023. http://dx.doi.org/10.14232/syrptbrs.2023.61.

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MATOS, Murilo Montanari de, and Sérgio Robles Reis de QUEIROZ. "Technical Change and the Incorporation of Biotechnology in the Pharmaceutical Industry." In II Encontro Nacional de Economia Industrial e Inovação. São Paulo: Editora Blucher, 2017. http://dx.doi.org/10.5151/enei2017-06.

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Sevick-Muraca, Eva M., and Steven Richter. "Frequency-Domain Photon Migration for Applications in the Biotechnology, Chemical, and Pharmaceutical Industry." In Biomedical Optical Spectroscopy and Diagnostics. Washington, D.C.: OSA, 2000. http://dx.doi.org/10.1364/bosd.2000.sue7.

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Li, Yinuo. "The impact of biotechnology and pharmaceutical industries on regional economies during the epidemic period." In 2021 3rd International Conference on Economic Management and Cultural Industry (ICEMCI 2021). Paris, France: Atlantis Press, 2021. http://dx.doi.org/10.2991/assehr.k.211209.323.

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Chen, Hsin-Po, Chia-Nan Wang, and Ming-Hsien Hsueh. "The Critical Success Factors of Biotechnology and Pharmaceutical Industry in SIAT---Integration Entrepreneur, Entrepreneurial Opportunity and Entrepreneurial Resource Perspective." In 2015 International Conference on Management Science and Innovative Education. Paris, France: Atlantis Press, 2015. http://dx.doi.org/10.2991/msie-15.2015.60.

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Menezes, Thiago, Carlos Gomes, Walter Santos Junior, Jorge Magalhães, and Gabriel Ferreira. "Agile Method of Qualification for Equipment at Pharmaceutical Industry of Biotechnology: A Case Study at Bio-Manguinhos ‘s Henrique Penna Center." In IV International Symposium on Immunobiologicals & VII Seminário Anual Científico e Tecnológico. Instituto de Tecnologia em Imunobiológicos, 2019. http://dx.doi.org/10.35259/isi.sact.2019_32771.

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Ziu, Christopher G., and Yaofeng Chen. "Use of Conical-Shaped Anchors to Reduce Stresses in Thermoplastic Dual Containment Piping Systems." In ASME 2005 Pressure Vessels and Piping Conference. ASMEDC, 2005. http://dx.doi.org/10.1115/pvp2005-71639.

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Double containment piping systems are used extensively for handling the conveyance of critical waste systems in industries such as pharmaceuticals and biotechnology manufacturing and research. Often, these services involve the conveyance of critical fluids at elevated temperatures. An example would be in the discharge and transport of spent fermentation by-products in the biotech industry, where the vessel contents are sanitized by the addition of water at up to 210°F and then discharged through double containment piping. Materials of construction used in such systems include thermoplastic, RTRP (fiberglass), stainless steel systems, and combinations thereof. This paper compares systems that are fully restrained by means of patented internal anchors designed to reduce stresses in components and evenly distribute the stresses to the secondary containment components. The systems are compared to the conventional methods of using thermoplastic systems restrained by unitary anchors. In addition to finite element analysis, physical tests are also performed to demonstrate the effectiveness of the conical shaped anchors.
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Reports on the topic "Pharmaceutical biotechnology industry"

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Greene, Anne, Kelly Waldron, and Nuala Calnan. Quality Risk Management: State of the Industry—Part 1. Has the Industry Realized the Full Value of ICH Q9? Institute of Validation Technology, January 2014. http://dx.doi.org/10.1080/21507090.ar1152014agkwnc-qrmsoi.

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This paper summarizes research designed to characterize the current state of pharmaceutical and biotechnology industries with respect to the adoption of Quality Risk Management as per ICH Q9. The research supports the hypotheses that the full value of QRM with respect to product quality and patient safety has not yet been realized. In addition, industry appears to be lagging behind regulatory expectations with respect to QRM maturity, indicating that current approaches to QRM require significant improvement.
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