-
1
-
-
0022783479
-
Biotechnology: The view from the FDA
-
Young FE. Biotechnology: the view from the FDA. Health Matrix 1986;4:10-15.
-
(1986)
Health Matrix
, vol.4
, pp. 10-15
-
-
Young, F.E.1
-
2
-
-
0242270743
-
Defining and characterizing the late-stage biopharmaceutical pipeline
-
Nagle PC, Lugo TF, Nicita CA. Defining and characterizing the late-stage biopharmaceutical pipeline. Am J Manag Care 2003;9:S124-135.
-
(2003)
Am J Manag Care
, vol.9
-
-
Nagle, P.C.1
Lugo, T.F.2
Nicita, C.A.3
-
3
-
-
49449091372
-
-
IMS Health. London: IMS Health
-
IMS Health. IMS lifecycle R&D focus. London: IMS Health, 2007
-
(2007)
IMS Lifecycle R&D Focus
-
-
-
4
-
-
33749422081
-
Market access for biopharmaceuticals: New challenges
-
Simon F. Market access for biopharmaceuticals: new challenges. Health Aff (Millwood) 2006;25:1363-1370
-
(2006)
Health Aff (Millwood)
, vol.25
, pp. 1363-1370
-
-
Simon, F.1
-
6
-
-
33645468877
-
Managing the expanded use of biologics across therapeutic areas: An example from b-cell targeted therapies
-
Cohen M, Morrow T, Penna P. Managing the expanded use of biologics across therapeutic areas: an example from b-cell targeted therapies. Am J Manag Care 2006;12:S24-37.
-
(2006)
Am J Manag Care
, vol.12
-
-
Cohen, M.1
Morrow, T.2
Penna, P.3
-
9
-
-
75149112660
-
Strategies for entering the biosimilar market
-
London: Biopharm Knowledge Publishing
-
Oldham T. Strategies for entering the biosimilar market. In: Biosimilars - Evolution or Revolution? London: Biopharm Knowledge Publishing, 2006.
-
(2006)
Biosimilars - Evolution or Revolution?
-
-
Oldham, T.1
-
12
-
-
44449151539
-
Follow-on biologics: Data exclusivity and the balance between innovation and competition
-
Grabowski H. Follow-on biologics: data exclusivity and the balance between innovation and competition. Nat Rev Drug Discov 2008;7:479-488
-
(2008)
Nat Rev Drug Discov
, vol.7
, pp. 479-488
-
-
Grabowski, H.1
-
13
-
-
0037374498
-
The price of innovation: New estimates of drug development costs
-
DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003;22:151-185
-
(2003)
J Health Econ
, vol.22
, pp. 151-185
-
-
Dimasi, J.A.1
Hansen, R.W.2
Grabowski, H.G.3
-
14
-
-
46149145516
-
Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
-
European Commission
-
European Commission. Regulation (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European Union 2004;1(L 136/1 - L 136/33).
-
(2004)
Official Journal of the European Union
, vol.1
-
-
-
15
-
-
68649124703
-
-
European Generic Medicines Association. Brussels: European Generic Medicines Association
-
European Generic Medicines Association. EGA Handbook on Biosimilar Medicines. Brussels: European Generic Medicines Association, 2008.
-
(2008)
EGA Handbook on Biosimilar Medicines
-
-
-
17
-
-
55349105870
-
Typical pitfalls in applications for marketing authorization of biotechnological products in Europe
-
Schneider CK, Schaffner-Dallmann G. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe. Nat Rev Drug Discov 2008;7:893-899
-
(2008)
Nat Rev Drug Discov
, vol.7
, pp. 893-899
-
-
Schneider, C.K.1
Schaffner-Dallmann, G.2
-
21
-
-
33749333428
-
Prices and availability of biopharmaceuticals: An international comparison
-
Danzon PM, Furukawa MF. Prices and availability of biopharmaceuticals: an international comparison. Health Aff (Millwood) 2006;25:1353-1362
-
(2006)
Health Aff (Millwood)
, vol.25
, pp. 1353-1362
-
-
Danzon, P.M.1
Furukawa, M.F.2
-
22
-
-
34748856993
-
The increasingly complex fourth hurdle for pharmaceuticals
-
Cohen J, Stolk E, Niezen M. The increasingly complex fourth hurdle for pharmaceuticals. Pharmacoeconomics 2007;25:727-734
-
(2007)
Pharmacoeconomics
, vol.25
, pp. 727-734
-
-
Cohen, J.1
Stolk, E.2
Niezen, M.3
-
23
-
-
0034945594
-
Health economic guidelines - Similarities, differences and some implications
-
Hjelmgren J, Berggren F, Andersson F. Health economic guidelines - similarities, differences and some implications. Value Health 2001;4:225-250
-
(2001)
Value Health
, vol.4
, pp. 225-250
-
-
Hjelmgren, J.1
Berggren, F.2
Andersson, F.3
-
24
-
-
33645826772
-
Economic and developmental considerations for pharmacogenomic technology
-
Vernon JA, Johnson SJ, Hughen WK, et al. Economic and developmental considerations for pharmacogenomic technology. Pharmacoeconomics 2006;24:335-343
-
(2006)
Pharmacoeconomics
, vol.24
, pp. 335-343
-
-
Vernon, J.A.1
Johnson, S.J.2
Hughen, W.K.3
-
26
-
-
45749123287
-
Multiple sclerosis risk-sharing: Four years on
-
Barham L. Multiple sclerosis risk-sharing: four years on. Pharma Pricing Reimbursement 2006;11:100-101
-
(2006)
Pharma Pricing Reimbursement
, vol.11
, pp. 100-101
-
-
Barham, L.1
-
27
-
-
33749345017
-
The market for follow-on biologics: How will it evolve?
-
Grabowski H, Cockburn I, Long G. The market for follow-on biologics: how will it evolve? Health Aff (Millwood) 2006;25:1291-1301
-
(2006)
Health Aff (Millwood)
, vol.25
, pp. 1291-1301
-
-
Grabowski, H.1
Cockburn, I.2
Long, G.3
-
28
-
-
33644952525
-
-
European Medicines Agency. London: European Medicines Agency
-
European Medicines Agency. Guideline on similar biological medicinal products. London: European Medicines Agency, 2006.
-
(2006)
Guideline on Similar Biological Medicinal Products
-
-
-
29
-
-
73549106371
-
-
International Society for Pharmacoeconomics and Outcomes Research. Lawrenceville, NJ: ISPOR
-
International Society for Pharmacoeconomics and Outcomes Research. Pharmacoeconomic Guidelines around the World. Lawrenceville, NJ: ISPOR, 2008.
-
(2008)
Pharmacoeconomic Guidelines Around the World
-
-
-
31
-
-
1542753592
-
Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: A nationwide study of community practices
-
Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 2003;21:4524-4531
-
(2003)
J Clin Oncol
, vol.21
, pp. 4524-4531
-
-
Lyman, G.H.1
Dale, D.C.2
Crawford, J.3
-
32
-
-
0025835219
-
Recombinant granulocyte colony-stimulating factor (rG-CSF). A review of its pharmacological properties and prospective role in neutropenic conditions
-
Hollingshead LM, Goa KL. Recombinant granulocyte colony-stimulating factor (rG-CSF). A review of its pharmacological properties and prospective role in neutropenic conditions. Drugs 1991;42:300-330
-
(1991)
Drugs
, vol.42
, pp. 300-330
-
-
Hollingshead, L.M.1
Goa, K.L.2
-
33
-
-
0036532256
-
Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: A meta-analysis
-
Lyman GH, Kuderer NM, Djulbegovic B. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis. Am J Med 2002;112:406-411
-
(2002)
Am J Med
, vol.112
, pp. 406-411
-
-
Lyman, G.H.1
Kuderer, N.M.2
Djulbegovic, B.3
-
35
-
-
0346100492
-
Economic evaluations of granulocyte colony-stimulating factor: In the prevention and treatment of chemotherapy-induced neutropenia
-
Esser M, Brunner H. Economic evaluations of granulocyte colony-stimulating factor: in the prevention and treatment of chemotherapy-induced neutropenia. Pharmacoeconomics 2003;21:1295-1313
-
(2003)
Pharmacoeconomics
, vol.21
, pp. 1295-1313
-
-
Esser, M.1
Brunner, H.2
-
36
-
-
75149178632
-
-
European Medicines Agency. London: European Medicines Agency
-
European Medicines Agency. Assessment report for Filgrastim Ratiopharm. London: European Medicines Agency, 2008.
-
(2008)
Assessment Report for Filgrastim Ratiopharm
-
-
-
37
-
-
0043248410
-
A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer
-
Siena S, Piccart MJ, Holmes FA, et al. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncol Rep 2003;10:715-724
-
(2003)
Oncol Rep
, vol.10
, pp. 715-724
-
-
Siena, S.1
Piccart, M.J.2
Holmes, F.A.3
-
38
-
-
41549115442
-
Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy
-
Eldar-Lissai A, Cosler LE, Culakova E, et al. Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health 2008;11:172-179
-
(2008)
Value Health
, vol.11
, pp. 172-179
-
-
Eldar-Lissai, A.1
Cosler, L.E.2
Culakova, E.3
-
39
-
-
64249170087
-
Cost-effectiveness of pegfilgrastim versus 6-day filgrastim primary prophylaxis in patients with non-Hodgkin's lymphoma receiving CHOP-21 in United States
-
Lyman G, Lalla A, Barron R, et al. Cost-effectiveness of pegfilgrastim versus 6-day filgrastim primary prophylaxis in patients with non-Hodgkin's lymphoma receiving CHOP-21 in United States. Curr Med Res Opin 2009;25:401-411
-
(2009)
Curr Med Res Opin
, vol.25
, pp. 401-411
-
-
Lyman, G.1
Lalla, A.2
Barron, R.3
-
40
-
-
60349114096
-
Cost-effectiveness of primary versus secondary prophylaxis with pegfilgrastim in women with early-stage breast cancer receiving chemotherapy
-
Ramsey S, Liu Z, Boer R, et al. Cost-effectiveness of primary versus secondary prophylaxis with pegfilgrastim in women with early-stage breast cancer receiving chemotherapy. Value Health 2009;12:217-225
-
(2009)
Value Health
, vol.12
, pp. 217-225
-
-
Ramsey, S.1
Liu, Z.2
Boer, R.3
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