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  1. European Federation of Pharmaceutical Industries and Associations (EFPIA), The Pharmaceutical Industry in Figures: Key Data 2013.  http://www.efpia.eu/uploads/FiguresKeyData2013.pdf [Accessed 5 August 2014].
  2. J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].
  3. Pharmaceutical Research and Manufacturers of America (PhRMA), 2013 Profile, Biopharmaceutical Research Industry.  http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf [Accessed 5 August 2014].
  4. Pharmaceutical Benefits Scheme (PBS) , http://www.pbs.gov.au/pbs/home [Accessed 5 August 2014].
  5. D. Dean, and F. Bruttin, , “Profiling costs in the hidden factory of pharmaceutical production”, PricewaterhouseCoopers, Pharma Sector Study and Report , Uxbridge, UK (1998).
  6. US FDA, Pharmaceutical cGMPs for the 21st century—a risk based approach, final report  (2004). http://www.fda.gov/drugs/developmentapprovaIprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm137175.htm [Accessed 31 July 2014].
  7. US FDA Guidance for Industry, PAT—a Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance  (2004). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070305.pdf [Accessed 31 July 2014].
  8. B. Swarbrick and B. Grout, and J. Noss, , “The rapid, at-line determination of starch content in sucrose–starch blends using near-infrared reflectance spectroscopy; a process analytical technology initiative”, J. Near Infrared Spectrosc.  13, 1 (2005). http://dx.doi.org/10.1255/jnirs.451
  9. E.W. Ciurczak, , “Following the progress of a pharmaceutical mixing study via near-infrared spectroscopy”, Pharm. Tech.  15, 141 (1991).
  10. M. Warman, “Continuous processing in secondary production”, in Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing , Ed by D.J. am Ende, John Wiley & Sons Ltd, Hoboken, NJ, pp. 837–851 (2011).
  11. B. Swarbrick, , “Advances in instrumental technology, industry guidance and data management systems enabling the widespread use of near infrared spectroscopy in the pharmaceutical/biopharmaceutical sector”, J. Near Infrared Spectrosc.  22, 157 (2014). doi: http://dx.doi.org/10.1255/jnirs.1121
  12. B. Grout, , “Application of NIR conformance trending for material quality, container consistency and minimization of process risk”, J. Near Infrared Spectrosc.  22, 169 (2014). doi: http://dx.doi.org/10.1255/jnirs.1118
  13. B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097
  14. D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116
  15. Y. Hattori, and M. Otsuka, , “Near infrared spectroscopic study of hydration/swelling process of microcrystalline cellulose, starch, and carboxymethylcellulose”, J. Near Infrared Spectrosc.  22, 199 (2014). doi: http://dx.doi.org/10.1255/jnirs.1111
  16. K. Awa and H. Shinzawa, and Y. Ozaki, , “Monitoring of recrystallization of microcrystalline cellulose inside pharmaceutical tablets during storage using near-infrared diffuse reflectance spectroscopy”, J. Near Infrared Spectrosc.  22, 205 (2014). doi: http://dx.doi.org/10.1255/jnirs.1117
  17. A.M. Brondi, L.A. Terra, G.P. Sabin, J.S. Garcia, and R.J. Poppi, and M.G. Trevisan, , “Mapping the polymorphic forms of fexofenadine in pharmaceutical tablets using near-infrared chemical imaging”, J. Near Infrared Spectrosc.  22, 211 (2014). doi: http://dx.doi.org/10.1255/jnirs.1094
  18. V.S. Barla, R. Kumar, V.R. Nalluri, and R.R. Gandhi, and K. Venkatesh, , “A practical evaluation of qualitative and quantitative chemometric models for real-time monitoring of moisture content in a fluidized bed dryer using NIR technology”, J. Near Infrared Spectrosc.  22, 221 (2014). doi: http://dx.doi.org/10.1255/jnirs.1095
  19. United States Congress: Office of Technology Assessment, “Pharmaceutical R&D: Costs, Risks & Rewards” , Appendix G, 302 (1993).
  20. O. Scheibelhofer, R. Hohl, S. Salar-Behzadi, D. Haack, K. Koch, P. Kerschhaggl, S. Sacher, and J.C. Menezes, and J.G. Khinast, , “Automatic correction for window fouling of near infrared probes in fluidized systems”, J. Near Infrared Spectrosc.  22, 229 (2014). doi: http://dx.doi.org/10.1255/jnirs.1102
  21. C. Cahyadi, W. Sasithornwetchakun, A. Topark-Ngarm, and L.W. Chan, and P.W.S. Heng, , “An evaluation of content uniformity of tablets prepared by quasi-continuous drug coating using near-infrared and Raman spectroscopy”, J. Near Infrared Spectrosc.  22, 239 (2014). doi: http://dx.doi.org/10.1255/jnirs.1120

2014 (10)

B. Swarbrick, , “Advances in instrumental technology, industry guidance and data management systems enabling the widespread use of near infrared spectroscopy in the pharmaceutical/biopharmaceutical sector”, J. Near Infrared Spectrosc.  22, 157 (2014). doi: http://dx.doi.org/10.1255/jnirs.1121

B. Grout, , “Application of NIR conformance trending for material quality, container consistency and minimization of process risk”, J. Near Infrared Spectrosc.  22, 169 (2014). doi: http://dx.doi.org/10.1255/jnirs.1118

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

Y. Hattori, and M. Otsuka, , “Near infrared spectroscopic study of hydration/swelling process of microcrystalline cellulose, starch, and carboxymethylcellulose”, J. Near Infrared Spectrosc.  22, 199 (2014). doi: http://dx.doi.org/10.1255/jnirs.1111

Y. Hattori, and M. Otsuka, , “Near infrared spectroscopic study of hydration/swelling process of microcrystalline cellulose, starch, and carboxymethylcellulose”, J. Near Infrared Spectrosc.  22, 199 (2014). doi: http://dx.doi.org/10.1255/jnirs.1111

K. Awa and H. Shinzawa, and Y. Ozaki, , “Monitoring of recrystallization of microcrystalline cellulose inside pharmaceutical tablets during storage using near-infrared diffuse reflectance spectroscopy”, J. Near Infrared Spectrosc.  22, 205 (2014). doi: http://dx.doi.org/10.1255/jnirs.1117

K. Awa and H. Shinzawa, and Y. Ozaki, , “Monitoring of recrystallization of microcrystalline cellulose inside pharmaceutical tablets during storage using near-infrared diffuse reflectance spectroscopy”, J. Near Infrared Spectrosc.  22, 205 (2014). doi: http://dx.doi.org/10.1255/jnirs.1117

A.M. Brondi, L.A. Terra, G.P. Sabin, J.S. Garcia, and R.J. Poppi, and M.G. Trevisan, , “Mapping the polymorphic forms of fexofenadine in pharmaceutical tablets using near-infrared chemical imaging”, J. Near Infrared Spectrosc.  22, 211 (2014). doi: http://dx.doi.org/10.1255/jnirs.1094

A.M. Brondi, L.A. Terra, G.P. Sabin, J.S. Garcia, and R.J. Poppi, and M.G. Trevisan, , “Mapping the polymorphic forms of fexofenadine in pharmaceutical tablets using near-infrared chemical imaging”, J. Near Infrared Spectrosc.  22, 211 (2014). doi: http://dx.doi.org/10.1255/jnirs.1094

V.S. Barla, R. Kumar, V.R. Nalluri, and R.R. Gandhi, and K. Venkatesh, , “A practical evaluation of qualitative and quantitative chemometric models for real-time monitoring of moisture content in a fluidized bed dryer using NIR technology”, J. Near Infrared Spectrosc.  22, 221 (2014). doi: http://dx.doi.org/10.1255/jnirs.1095

V.S. Barla, R. Kumar, V.R. Nalluri, and R.R. Gandhi, and K. Venkatesh, , “A practical evaluation of qualitative and quantitative chemometric models for real-time monitoring of moisture content in a fluidized bed dryer using NIR technology”, J. Near Infrared Spectrosc.  22, 221 (2014). doi: http://dx.doi.org/10.1255/jnirs.1095

O. Scheibelhofer, R. Hohl, S. Salar-Behzadi, D. Haack, K. Koch, P. Kerschhaggl, S. Sacher, and J.C. Menezes, and J.G. Khinast, , “Automatic correction for window fouling of near infrared probes in fluidized systems”, J. Near Infrared Spectrosc.  22, 229 (2014). doi: http://dx.doi.org/10.1255/jnirs.1102

O. Scheibelhofer, R. Hohl, S. Salar-Behzadi, D. Haack, K. Koch, P. Kerschhaggl, S. Sacher, and J.C. Menezes, and J.G. Khinast, , “Automatic correction for window fouling of near infrared probes in fluidized systems”, J. Near Infrared Spectrosc.  22, 229 (2014). doi: http://dx.doi.org/10.1255/jnirs.1102

C. Cahyadi, W. Sasithornwetchakun, A. Topark-Ngarm, and L.W. Chan, and P.W.S. Heng, , “An evaluation of content uniformity of tablets prepared by quasi-continuous drug coating using near-infrared and Raman spectroscopy”, J. Near Infrared Spectrosc.  22, 239 (2014). doi: http://dx.doi.org/10.1255/jnirs.1120

C. Cahyadi, W. Sasithornwetchakun, A. Topark-Ngarm, and L.W. Chan, and P.W.S. Heng, , “An evaluation of content uniformity of tablets prepared by quasi-continuous drug coating using near-infrared and Raman spectroscopy”, J. Near Infrared Spectrosc.  22, 239 (2014). doi: http://dx.doi.org/10.1255/jnirs.1120

2007 (1)

J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].

J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].

2005 (1)

1991 (1)

E.W. Ciurczak, , “Following the progress of a pharmaceutical mixing study via near-infrared spectroscopy”, Pharm. Tech.  15, 141 (1991).

Anderson, C.A.

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

Awa, K.

Barla, V.S.

Brondi, A.M.

Bruttin, F.

D. Dean, and F. Bruttin, , “Profiling costs in the hidden factory of pharmaceutical production”, PricewaterhouseCoopers, Pharma Sector Study and Report , Uxbridge, UK (1998).

Cahyadi, C.

Chan, L.W.

Ciurczak, E.W.

E.W. Ciurczak, , “Following the progress of a pharmaceutical mixing study via near-infrared spectroscopy”, Pharm. Tech.  15, 141 (1991).

Dean, D.

D. Dean, and F. Bruttin, , “Profiling costs in the hidden factory of pharmaceutical production”, PricewaterhouseCoopers, Pharma Sector Study and Report , Uxbridge, UK (1998).

DiMasi, J.A.

J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].

Drennen, J. K.

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

Gandhi, R.R.

Garcia, J.S.

Genkawa, T.

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

Grabowski, H.G.

J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].

Grout, B.

Haack, D.

Hattori, Y.

Heng, P.W.S.

Hohl, R.

Hossain, N.

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

Igne, B.

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

Ishikawa, D.

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

Kerschhaggl, P.

Khinast, J.G.

Koch, K.

Komiyama, M.

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

Kumar, R.

Menezes, J.C.

Murayama, K.

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

Nalluri, V.R.

Noss, J.

Otsuka, M.

Ozaki, Y.

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

K. Awa and H. Shinzawa, and Y. Ozaki, , “Monitoring of recrystallization of microcrystalline cellulose inside pharmaceutical tablets during storage using near-infrared diffuse reflectance spectroscopy”, J. Near Infrared Spectrosc.  22, 205 (2014). doi: http://dx.doi.org/10.1255/jnirs.1117

Poppi, R.J.

Sabin, G.P.

Sacher, S.

Salar-Behzadi, S.

Sasithornwetchakun, W.

Scheibelhofer, O.

Shinzawa, H.

Swarbrick, B.

Terra, L.A.

Topark-Ngarm, A.

Trevisan, M.G.

Venkatesh, K.

Warman, M.

M. Warman, “Continuous processing in secondary production”, in Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing , Ed by D.J. am Ende, John Wiley & Sons Ltd, Hoboken, NJ, pp. 837–851 (2011).

J. Near Infrared Spectrosc (2)

B. Igne, N. Hossain, and J. K. Drennen, and C.A. Anderson, , “Robustness considerations and effects of moisture variations on near infrared method performance for solid dosage form assay”, J. Near Infrared Spectrosc ,  22, 179 (2014). doi: http://dx.doi.org/10.1255/jnirs.1097

D. Ishikawa, T. Genkawa, K. Murayama, and M. Komiyama, and Y. Ozaki, , “Feasibility study of diffuse reflectance and transmittance near-infrared spectroscopy for rapid analysis of ascorbic-acid concentration in bilayer tablets using high-speed polychromator-type spectrometer”, J. Near Infrared Spectrosc ,  22, 189 (2014). doi: http://dx.doi.org/10.1255/jnirs.1116

J. Near Infrared Spectrosc. (9)

Y. Hattori, and M. Otsuka, , “Near infrared spectroscopic study of hydration/swelling process of microcrystalline cellulose, starch, and carboxymethylcellulose”, J. Near Infrared Spectrosc.  22, 199 (2014). doi: http://dx.doi.org/10.1255/jnirs.1111

K. Awa and H. Shinzawa, and Y. Ozaki, , “Monitoring of recrystallization of microcrystalline cellulose inside pharmaceutical tablets during storage using near-infrared diffuse reflectance spectroscopy”, J. Near Infrared Spectrosc.  22, 205 (2014). doi: http://dx.doi.org/10.1255/jnirs.1117

A.M. Brondi, L.A. Terra, G.P. Sabin, J.S. Garcia, and R.J. Poppi, and M.G. Trevisan, , “Mapping the polymorphic forms of fexofenadine in pharmaceutical tablets using near-infrared chemical imaging”, J. Near Infrared Spectrosc.  22, 211 (2014). doi: http://dx.doi.org/10.1255/jnirs.1094

V.S. Barla, R. Kumar, V.R. Nalluri, and R.R. Gandhi, and K. Venkatesh, , “A practical evaluation of qualitative and quantitative chemometric models for real-time monitoring of moisture content in a fluidized bed dryer using NIR technology”, J. Near Infrared Spectrosc.  22, 221 (2014). doi: http://dx.doi.org/10.1255/jnirs.1095

O. Scheibelhofer, R. Hohl, S. Salar-Behzadi, D. Haack, K. Koch, P. Kerschhaggl, S. Sacher, and J.C. Menezes, and J.G. Khinast, , “Automatic correction for window fouling of near infrared probes in fluidized systems”, J. Near Infrared Spectrosc.  22, 229 (2014). doi: http://dx.doi.org/10.1255/jnirs.1102

C. Cahyadi, W. Sasithornwetchakun, A. Topark-Ngarm, and L.W. Chan, and P.W.S. Heng, , “An evaluation of content uniformity of tablets prepared by quasi-continuous drug coating using near-infrared and Raman spectroscopy”, J. Near Infrared Spectrosc.  22, 239 (2014). doi: http://dx.doi.org/10.1255/jnirs.1120

B. Swarbrick and B. Grout, and J. Noss, , “The rapid, at-line determination of starch content in sucrose–starch blends using near-infrared reflectance spectroscopy; a process analytical technology initiative”, J. Near Infrared Spectrosc.  13, 1 (2005). http://dx.doi.org/10.1255/jnirs.451

B. Swarbrick, , “Advances in instrumental technology, industry guidance and data management systems enabling the widespread use of near infrared spectroscopy in the pharmaceutical/biopharmaceutical sector”, J. Near Infrared Spectrosc.  22, 157 (2014). doi: http://dx.doi.org/10.1255/jnirs.1121

B. Grout, , “Application of NIR conformance trending for material quality, container consistency and minimization of process risk”, J. Near Infrared Spectrosc.  22, 169 (2014). doi: http://dx.doi.org/10.1255/jnirs.1118

Manage. Decis. Econ. (1)

J.A. DiMasi, and H.G. Grabowski, , “The cost of biopharmaceutical R&D: Is biotech different?”, Manage. Decis. Econ.  28, 469 (2007). http://dx.doi.org/10.1002/mde.1360 [Accessed 5 August 2014].

Pharm. Tech. (1)

E.W. Ciurczak, , “Following the progress of a pharmaceutical mixing study via near-infrared spectroscopy”, Pharm. Tech.  15, 141 (1991).

Other (8)

M. Warman, “Continuous processing in secondary production”, in Chemical Engineering in the Pharmaceutical Industry: R&D to Manufacturing , Ed by D.J. am Ende, John Wiley & Sons Ltd, Hoboken, NJ, pp. 837–851 (2011).

Pharmaceutical Research and Manufacturers of America (PhRMA), 2013 Profile, Biopharmaceutical Research Industry.  http://www.phrma.org/sites/default/files/pdf/PhRMA%20Profile%202013.pdf [Accessed 5 August 2014].

Pharmaceutical Benefits Scheme (PBS) , http://www.pbs.gov.au/pbs/home [Accessed 5 August 2014].

D. Dean, and F. Bruttin, , “Profiling costs in the hidden factory of pharmaceutical production”, PricewaterhouseCoopers, Pharma Sector Study and Report , Uxbridge, UK (1998).

US FDA, Pharmaceutical cGMPs for the 21st century—a risk based approach, final report  (2004). http://www.fda.gov/drugs/developmentapprovaIprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm137175.htm [Accessed 31 July 2014].

US FDA Guidance for Industry, PAT—a Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance  (2004). http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070305.pdf [Accessed 31 July 2014].

European Federation of Pharmaceutical Industries and Associations (EFPIA), The Pharmaceutical Industry in Figures: Key Data 2013.  http://www.efpia.eu/uploads/FiguresKeyData2013.pdf [Accessed 5 August 2014].

United States Congress: Office of Technology Assessment, “Pharmaceutical R&D: Costs, Risks & Rewards” , Appendix G, 302 (1993).

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