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Volumn 9780521870986, Issue , 2008, Pages 1-335

Commercializing successful biomedical technologies: Basic principles for the development of drugs, diagnostics and devices

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; CURRICULA; DIAGNOSIS; PRODUCT DEVELOPMENT; STUDENTS;

EID: 84924699119     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1017/CBO9780511791345     Document Type: Book
Times cited : (40)

References (128)
  • 7
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi, J. A., Hansen, R. W., and Grabowski, H. G. The price of innovation: new estimates of drug development costs, Journal of Health Economics, 22, 151–185, 2003.
    • (2003) Journal of Health Economics , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 18
    • 85032396720 scopus 로고    scopus 로고
    • Biotechnology Industry Organization
    • www.bio.org – Biotechnology Industry Organization
  • 19
    • 85032402346 scopus 로고    scopus 로고
    • Pharmaceutical Research and Manufacturers Association
    • www.phrma.org – Pharmaceutical Research and Manufacturers Association
  • 20
    • 84924660564 scopus 로고    scopus 로고
    • Medical Device Manufacturers Association (mostly small to midsized device and diagnostics companies)
    • www.medicaldevices.org – Medical Device Manufacturers Association (mostly small to midsized device and diagnostics companies)
  • 21
    • 84924660563 scopus 로고    scopus 로고
    • Advanced Medical Technology Association (large medical device manufacturers’ advocacy and lobbying association)
    • www.advamed.org – Advanced Medical Technology Association (large medical device manufacturers’ advocacy and lobbying association)
  • 22
    • 85032396547 scopus 로고    scopus 로고
    • –, Medical Device Link (trade publication)
    • www.devicelink.com – Medical Device Link (trade publication)
  • 23
    • 84924660561 scopus 로고    scopus 로고
    • Society for Biomaterials
    • www.biomaterials.org – Society for Biomaterials
  • 26
    • 84924726038 scopus 로고    scopus 로고
    • Standard and Poor’s
    • Standard and Poor’s. Medical Device Industry Survey, Standard and Poor’s, 2004.
    • (2004) Medical Device Industry Survey
  • 27
    • 0003579807 scopus 로고    scopus 로고
    • 3rd edn., McGraw-Hill, Boston, MA, Note – this book also has a practical section on working out client orcustomer needs through various steps of market research)
    • Ulrich, K. T. and Eppinger, S. D., Product Design and Development, 3rd edn., McGraw-Hill, Boston, MA, 2003. (Note – this book also has a practical section on working out client orcustomer needs through various steps of market research).
    • (2003) Product Design and Development
    • Ulrich, K.T.1    Eppinger, S.D.2
  • 28
    • 84924660560 scopus 로고    scopus 로고
    • Biotech and the spoils of success
    • August 13
    • Weintraub, A. Biotech and the spoils of success, Business Week, August 13, 2001.
    • (2001) Business Week
    • Weintraub, A.1
  • 29
    • 84924660559 scopus 로고    scopus 로고
    • The National Center for Health Statistics for information on disease incidence and prevalence in the USA
    • www.cdc.gov/nchs – The National Center for Health Statistics for information on disease incidence and prevalence in the USA
  • 30
    • 84924660558 scopus 로고    scopus 로고
    • The National Hospital Discharge Survey gives detailed numbers of admissions for each disease and numbers of each major surgical procedure that is performed in the USA
    • www.cdc.gov/nchs/about/major/hdasd/listpubs.htm – The National Hospital Discharge Survey gives detailed numbers of admissions for each disease and numbers of each major surgical procedure that is performed in the USA.
  • 31
    • 85032395492 scopus 로고    scopus 로고
    • Prescription drug sales information reports
    • www.imshealth.com – Prescription drug sales information reports
  • 32
    • 84924660556 scopus 로고    scopus 로고
    • Orphan indications
    • http://rarediseases.about.com/– Orphan indications
  • 33
    • 84924660555 scopus 로고    scopus 로고
    • Symptoms, disease description, and epidemiology
    • www.wrongdiagnosis.com/– Symptoms, disease description, and epidemiology
  • 34
    • 85032404185 scopus 로고    scopus 로고
    • Hoover’s industry lists
    • www.hoovers.com – Hoover’s industry lists
  • 35
    • 84924660553 scopus 로고    scopus 로고
    • Navigate from www.lib.rpi.edu home page by clicking through Home>Research assistance>Course web pages>Lally School –Resources webpage for market research
    • Navigate from www.lib.rpi.edu home page by clicking through Home>Research assistance>Course web pages>Lally School – Resources webpage for market research
  • 36
    • 85016850483 scopus 로고    scopus 로고
    • University–industry collaborations: Partners in research promoting productivity and economic growth
    • Breneman, L. University–industry collaborations: partners in research promoting productivity and economic growth, Research Management Review, 13(2), 2003.
    • (2003) Research Management Review , vol.13 , Issue.2
    • Breneman, L.1
  • 42
    • 85032396050 scopus 로고    scopus 로고
    • Will stent makers fight dentist’s patent tooth and nail?
    • January 26
    • Winslow, R. Will stent makers fight dentist’s patent tooth and nail? Wall Street Journal, January 26, p. B1, 2006.
    • (2006) Wall Street Journal
    • Winslow, R.1
  • 43
    • 84924660549 scopus 로고    scopus 로고
    • –US patent and trademark office
    • www.uspto.gov – US patent and trademark office
  • 44
    • 84924660548 scopus 로고    scopus 로고
    • WIPO
    • www.wipo.org – WIPO
  • 45
    • 84924660547 scopus 로고    scopus 로고
    • European patent office
    • www.epo.org – European patent office
  • 46
    • 84924660546 scopus 로고    scopus 로고
    • Trademark link
    • www.uspto.gov/main/trademarks.htm and www.ladas.com/Trademarks/tmprot.html – Trademark link
  • 47
    • 84924660545 scopus 로고    scopus 로고
    • US PTO: patent processing times
    • www.uspto.gov/web/offices/com/annual/2005/040201_patentperform.html – US PTO: patent processing times
  • 48
    • 85032398143 scopus 로고    scopus 로고
    • www.patentbaristas.com
  • 49
    • 85032401899 scopus 로고    scopus 로고
    • www.patentdocs.us
  • 52
    • 0000233924 scopus 로고
    • The new product process: A decision guide for managers
    • Cooper, R. G. The new product process: a decision guide for managers. Journal of Marketing Management, 3, (3) 238–255, 1988.
    • (1988) Journal of Marketing Management , vol.3 , Issue.3 , pp. 238-255
    • Cooper, R.G.1
  • 53
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi, J. A., Hansen, R. W., and Grabowski, H. G. The price of innovation: new estimates of drug development costs, Journal of Health Economics, 22, 151–185, 2003.
    • (2003) Journal of Health Economics , vol.22 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 56
    • 49649152187 scopus 로고
    • Matrix organization designs – how to combine functional and project forms
    • Galbraith, J. R., Matrix organization designs – how to combine functional and project forms, Business Horizons, 17, 1, 29–40, 1971.
    • (1971) Business Horizons , vol.17 , Issue.1 , pp. 29-40
    • Galbraith, J.R.1
  • 62
    • 0030528170 scopus 로고    scopus 로고
    • Marketing and discontinuous innovation: The probe and learn process
    • Lynn, G. S, Morone, J. G., and Paulson, A. S. Marketing and discontinuous innovation: the probe and learn process, California Management Review, 38(3), 8–37, 1996.
    • (1996) California Management Review , vol.38 , Issue.3 , pp. 8-37
    • Lynn, G.S.1    Morone, J.G.2    Paulson, A.S.3
  • 65
    • 0023947965 scopus 로고
    • Pharmaceutical innovation by the seven uk-owned pharmaceutical companies (1964–1985)
    • Prentis, R. A., Lis, Y., and Walker, S. R. Pharmaceutical innovation by the seven UK-owned pharmaceutical companies (1964–1985), British Journal of Clinical Pharmacology, 25, 387–396, 1988.
    • (1988) British Journal of Clinical Pharmacology , vol.25 , pp. 387-396
    • Prentis, R.A.1    Lis, Y.2    Walker, S.R.3
  • 69
    • 84924660541 scopus 로고    scopus 로고
    • Code of Federal regulations
    • www.gpoaccess.gov/cfr – Code of Federal regulations
  • 70
    • 85032398282 scopus 로고    scopus 로고
    • Animal care guidelines
    • http://grants.nih.gov/grants/olaw/references/outline.htm – Animal care guidelines
  • 71
    • 84924660539 scopus 로고    scopus 로고
    • Devices: quality systems regulations
    • www.fda.gov/cdrh/qsr/contnt.html – Devices: quality systems regulations
  • 72
    • 84924660538 scopus 로고    scopus 로고
    • Clinical trials for devices
    • www.fda.gov/cdrh/ode/ot476.html – Clinical trials for devices
  • 73
    • 84924660537 scopus 로고    scopus 로고
    • Clinical studies for diagnostics
    • www.fda.gov/cdrh/oivd/guidance/1549.html – Clinical studies for diagnostics
  • 74
    • 84924660536 scopus 로고    scopus 로고
    • Clinical studies for drugs (biologics)
    • www.fda.gov/oc/ohrt/irbs/drugsbiologics.html#study – Clinical studies for drugs (biologics)
  • 75
    • 84924660535 scopus 로고    scopus 로고
    • Product development critical path
    • http://en.wikipedia.org/wiki/Critical_path_method – Product development critical path
  • 76
    • 84924660534 scopus 로고    scopus 로고
    • Quality certification standards (ISO)
    • www.iso.ch – Quality certification standards (ISO)
  • 81
    • 84924660531 scopus 로고    scopus 로고
    • W.L
    • Pines, (ed.)., Food and Drug Law Institute, 2nd edn
    • Pines, W.L. (ed.). How to Work With the FDA, Food and Drug Law Institute, 2nd edn., 2003.
    • (2003) How to Work with the FDA
  • 84
    • 84924660530 scopus 로고    scopus 로고
    • Quality systems regulations for devices
    • www.fda.gov/cdrh/qsr/contnt.html – Quality systems regulations for devices
  • 85
    • 85032412494 scopus 로고    scopus 로고
    • –, Regulatory Affairs Professionals Society of America
    • www.raps.org – Regulatory Affairs Professionals Society of America
  • 86
    • 84924660528 scopus 로고    scopus 로고
    • A list of foreign regulatory bodies and links to their websites
    • www.pharmweb.net/pwmirror/pwk/pharmwebk.html – A list of foreign regulatory bodies and links to their websites
  • 87
    • 85032403439 scopus 로고    scopus 로고
    • –, UK: MHRA (Medicines and Healthcare products Regulatory Agency, UK)
    • www.mhra.gov.uk/– UK: MHRA (Medicines and Healthcare products Regulatory Agency, UK)
  • 88
    • 85032418540 scopus 로고    scopus 로고
    • EMEA: The European Medicines Agency
    • www.emea.europa.eu/– EMEA: The European Medicines Agency
  • 89
    • 85032424340 scopus 로고    scopus 로고
    • –, Australia: Therapeutics Goods Administration
    • www.tga.gov.au/– Australia: Therapeutics Goods Administration
  • 90
    • 85032418589 scopus 로고    scopus 로고
    • Health Canada
    • www.hc-sc.gc.ca/index_e.html – Health Canada
  • 91
    • 84924660523 scopus 로고    scopus 로고
    • Japan: Ministry of Health and Welfare
    • www.mhlw.go.jp/english/index.html – Japan: Ministry of Health and Welfare
  • 92
    • 8844226928 scopus 로고    scopus 로고
    • Factory shift: New prescription for drug makers
    • (Eastern edn.), September 3
    • Abboud, L. and Hensley, S. Factory shift: new prescription for drug makers, The Wall Street Journal, (Eastern edn.), September 3, p. A1, 2003.
    • (2003) The Wall Street Journal
    • Abboud, L.1    Hensley, S.2
  • 100
    • 84924660522 scopus 로고    scopus 로고
    • Standards – ABCs of standards in the USA
    • http://ts.nist.gov/Standards/Conformity/stdpmr.cfm – Standards – ABCs of standards in the USA
  • 101
    • 84924660521 scopus 로고    scopus 로고
    • ISO website
    • www.iso.org/iso/en/aboutiso/introduction/index.html – ISO website
  • 102
    • 84924660520 scopus 로고    scopus 로고
    • Clean rooms
    • www.fda.gov/cder/guidance/5882fnl.pdf – Clean rooms
  • 103
    • 84924660519 scopus 로고    scopus 로고
    • Process validation guidance
    • www.fda.gov/cder/guidance/pv.htm – Process validation guidance
  • 104
    • 84924660518 scopus 로고    scopus 로고
    • International society for technical professionals in the healthcare manufacturing industry
    • www.ispe.org – International society for technical professionals in the healthcare manufacturing industry
  • 114
    • 84924660516 scopus 로고    scopus 로고
    • CMS Centers for Medicaid and Medicare Services
    • www.cms.gov – CMS Centers for Medicaid and Medicare Services
  • 115
    • 84924660515 scopus 로고    scopus 로고
    • MedPAC –advise Congress on Medicare (summary documents on Medicare processes; look under “other publications” link)
    • www.medpac.gov – MedPAC – advise Congress on Medicare (summary documents on Medicare processes; look under “other publications” link)
  • 116
    • 85032405621 scopus 로고    scopus 로고
    • Medicare coverage database (search for national and local coverage decisions)
    • www.cms.hhs.gov/mcd/search.asp – Medicare coverage database (search for national and local coverage decisions)
  • 117
    • 84924660513 scopus 로고    scopus 로고
    • HCPCS codes at CMS
    • www.cms.hhs.gov/MedHCPCSGenInfo/– HCPCS codes at CMS
  • 118
    • 85032409842 scopus 로고    scopus 로고
    • How a new CPT code is created
    • www.ama-assn.org/ama/pub/category/3882.html – How a new CPT code is created
  • 119
    • 84924660335 scopus 로고    scopus 로고
    • Useful list of acronyms used in healthcare and by CMS
    • www.cms.hhs.gov/apps/acronyms/– Useful list of acronyms used in healthcare and by CMS
  • 120
    • 85032418004 scopus 로고    scopus 로고
    • Glossary for drug pricing terms
    • www.hrsa.gov/opa/glossary.htm – Glossary for drug pricing terms
  • 121
    • 84924660333 scopus 로고    scopus 로고
    • Outpatient Prospective Payment system at Medicare
    • www.cms.hhs.gov/HospitalOutpatientPPS/– Outpatient Prospective Payment system at Medicare
  • 122
    • 84924660332 scopus 로고    scopus 로고
    • Medicare physician fee schedule
    • www.cms.hhs.gov/PhysicianFeeSched/– Medicare physician fee schedule
  • 123
    • 85032419863 scopus 로고    scopus 로고
    • Kaiser Family Foundation
    • www.kff.org – Kaiser Family Foundation
  • 124
    • 84924660330 scopus 로고    scopus 로고
    • Leonard Davis Institute of Health Economics
    • www.upenn.edu/ldi – Leonard Davis Institute of Health Economics
  • 125
    • 84924660329 scopus 로고    scopus 로고
    • National Bureau of Economic Research (has many working papers on healthrelated topics)
    • www.nber.org – National Bureau of Economic Research (has many working papers on healthrelated topics)
  • 126
    • 84924660328 scopus 로고    scopus 로고
    • National Health Service (United Kingdom)
    • www.nhs.uk/– National Health Service (United Kingdom)
  • 127
    • 84924660327 scopus 로고    scopus 로고
    • National Center for Health Statistics (USA)
    • www.cdc.gov/nchs/– National Center for Health Statistics (USA)
  • 128
    • 84924660316 scopus 로고    scopus 로고
    • WHO (World Health Organization) statistical information system
    • www.who.int/whosis/– WHO (World Health Organization) statistical information system


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.