-
1
-
-
84871478745
-
Biosimilars: company strategies to capture value from the biologics market
-
Calo-Fernández B, Martínez-Hurtado JL Biosimilars: company strategies to capture value from the biologics market. Pharmaceuticals (Basel) 2012, 5:1393-1408.
-
(2012)
Pharmaceuticals (Basel)
, vol.5
, pp. 1393-1408
-
-
Calo-Fernández, B.1
Martínez-Hurtado, J.L.2
-
2
-
-
84896883598
-
Biosimilars: how similar?
-
Strand V, Cronstein B Biosimilars: how similar?. Intern Med J 2014, 44:218-223.
-
(2014)
Intern Med J
, vol.44
, pp. 218-223
-
-
Strand, V.1
Cronstein, B.2
-
3
-
-
84924093309
-
Biosimilar products are not bioidentical
-
Garber AJ Biosimilar products are not bioidentical. J Diabetes 2015, 7:153-154.
-
(2015)
J Diabetes
, vol.7
, pp. 153-154
-
-
Garber, A.J.1
-
4
-
-
84904304395
-
Biosimilar: an overview
-
Kanase SJ, Gavhane YN, Khandekar A, Gurav AS, Yadav AV Biosimilar: an overview. Int J Pharm Sci Rev Res 2013, 4:2132.
-
(2013)
Int J Pharm Sci Rev Res
, vol.4
, pp. 2132
-
-
Kanase, S.J.1
Gavhane, Y.N.2
Khandekar, A.3
Gurav, A.S.4
Yadav, A.V.5
-
5
-
-
84899412968
-
Biosimilars in oncology: from development to clinical practice
-
Rak Tkaczuk KH, Jacobs IA Biosimilars in oncology: from development to clinical practice. Semin Oncol 2014, 41(suppl 3):S3-12.
-
(2014)
Semin Oncol
, vol.41
, pp. S3-12
-
-
Rak Tkaczuk, K.H.1
Jacobs, I.A.2
-
6
-
-
70450195261
-
Controlling the cost of innovative cancer therapeutics
-
Malik NN Controlling the cost of innovative cancer therapeutics. Nat Rev Clin Oncol 2009, 6:550-552.
-
(2009)
Nat Rev Clin Oncol
, vol.6
, pp. 550-552
-
-
Malik, N.N.1
-
7
-
-
84857905655
-
The economic pressures for biosimilar drug use in cancer medicine
-
Cornes P The economic pressures for biosimilar drug use in cancer medicine. Target Oncol 2012, 7(suppl 1):S57-S67.
-
(2012)
Target Oncol
, vol.7
, pp. S57-S67
-
-
Cornes, P.1
-
8
-
-
34548147147
-
Basic facts about biosimilars
-
Nowicki M Basic facts about biosimilars. Kidney Blood Press Res 2007, 30:267-272.
-
(2007)
Kidney Blood Press Res
, vol.30
, pp. 267-272
-
-
Nowicki, M.1
-
9
-
-
84924854592
-
Regulatory and clinical considerations for biosimilar oncology drugs
-
Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol 2014, 15:e594-e605.
-
(2014)
Lancet Oncol
, vol.15
, pp. e594-e605
-
-
Bennett, C.L.1
Chen, B.2
Hermanson, T.3
-
10
-
-
79851500792
-
Toward an understanding of high performance pharmaceutical policy systems: a "Triple-A" framework and example analysis
-
Morgan S, Kennedy J, Boothe K, McMahon M, Watson D, Roughead E Toward an understanding of high performance pharmaceutical policy systems: a "Triple-A" framework and example analysis. Open Health Serv Policy J 2009, 2:1-9.
-
(2009)
Open Health Serv Policy J
, vol.2
, pp. 1-9
-
-
Morgan, S.1
Kennedy, J.2
Boothe, K.3
McMahon, M.4
Watson, D.5
Roughead, E.6
-
11
-
-
77953343625
-
Biosimilars: current status and future directions
-
Roger SD Biosimilars: current status and future directions. Expert Opin Biol Ther 2010, 10:1011-1018.
-
(2010)
Expert Opin Biol Ther
, vol.10
, pp. 1011-1018
-
-
Roger, S.D.1
-
12
-
-
84955268675
-
-
(accessed Aug 27, 2015).
-
European public assessment reports: authorized biosimilars European Medicines Agency, (accessed Aug 27, 2015). http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125.
-
European public assessment reports: authorized biosimilars
-
-
-
13
-
-
84955307891
-
-
(accessed March 25, 2015).
-
Assessing biosimilar uptake and competition in European markets IMS Institute for Healthcare Informatics, (accessed March 25, 2015). http://www.imshealth.com/imshealth/Global/Content/Corporate/IMS%20Health%20Institute/Insights/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf.
-
Assessing biosimilar uptake and competition in European markets
-
-
-
15
-
-
84955277282
-
Tbo-filgrastim shows significant cost savings for payers
-
Koutnik-Fotopoulos E Tbo-filgrastim shows significant cost savings for payers. First Rep Managed Care 2014, 11.
-
(2014)
First Rep Managed Care
, vol.11
-
-
Koutnik-Fotopoulos, E.1
-
16
-
-
84924412512
-
First US biosimilar edges towards market
-
Senior M First US biosimilar edges towards market. Nat Biotechnol 2015, 33:222-223.
-
(2015)
Nat Biotechnol
, vol.33
, pp. 222-223
-
-
Senior, M.1
-
17
-
-
84955283456
-
-
(accessed April 15, 2015).
-
FDA approves first biosimilar Zarxio US Food and Drug Administration, (accessed April 15, 2015). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm.
-
FDA approves first biosimilar Zarxio
-
-
-
18
-
-
84955244698
-
US Court of Appeals for the Federal Circuit
-
(accessed Aug 28, 2015).
-
Amgen, Inc. vs Sandoz, Inc., No. 15-1499 US Court of Appeals for the Federal Circuit, (accessed Aug 28, 2015). http://law.justia.com/cases/federal/appellate-courts/cafc/15-1499/15-1499-2015-07-21.html.
-
Amgen, Inc. vs Sandoz, Inc., No. 15-1499
-
-
-
20
-
-
84870933584
-
Interchangeability, immunogenicity and biosimilars
-
Ebbers HC, Crow SA, Vulto AG, Schellekens H Interchangeability, immunogenicity and biosimilars. Nat Biotechnol 2012, 30:1186-1190.
-
(2012)
Nat Biotechnol
, vol.30
, pp. 1186-1190
-
-
Ebbers, H.C.1
Crow, S.A.2
Vulto, A.G.3
Schellekens, H.4
-
22
-
-
84905717145
-
Statistical and regulatory considerations in assessments of interchangeability of biological drug products
-
Tóthfalusi L, Endrényi L, Chow SC Statistical and regulatory considerations in assessments of interchangeability of biological drug products. Eur J Health Econ 2014, 15(suppl 1):S5-11.
-
(2014)
Eur J Health Econ
, vol.15
, pp. S5-11
-
-
Tóthfalusi, L.1
Endrényi, L.2
Chow, S.C.3
-
24
-
-
84878080621
-
Biosimilars: part 1: proposed regulatory criteria for FDA approval
-
Ventola CL Biosimilars: part 1: proposed regulatory criteria for FDA approval. P T 2013, 38:270-287.
-
(2013)
P T
, vol.38
, pp. 270-287
-
-
Ventola, C.L.1
-
26
-
-
80054922640
-
NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives
-
Zelenetz AD, Ahmed I, Braud EL, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw 2011, 9(suppl 4):S1-22.
-
(2011)
J Natl Compr Canc Netw
, vol.9
, pp. S1-22
-
-
Zelenetz, A.D.1
Ahmed, I.2
Braud, E.L.3
-
27
-
-
41149131276
-
Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment
-
the Epoetin Zeta Study Group
-
Wizemann V, Rutkowski B, Baldamus C, Scigalla P, Koytchev R Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Curr Med Res Opin 2008, 24:625-637. the Epoetin Zeta Study Group.
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 625-637
-
-
Wizemann, V.1
Rutkowski, B.2
Baldamus, C.3
Scigalla, P.4
Koytchev, R.5
-
28
-
-
66949138584
-
Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: an open-label, randomized-sequence, three-treatment, three-way crossover study
-
Cho SH, Lim HS, Ghim JL, et al. Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: an open-label, randomized-sequence, three-treatment, three-way crossover study. Clin Ther 2009, 31:1046-1053.
-
(2009)
Clin Ther
, vol.31
, pp. 1046-1053
-
-
Cho, S.H.1
Lim, H.S.2
Ghim, J.L.3
-
31
-
-
69449095403
-
Biosimilar therapeutics-what do we need to consider?
-
Schellekens H Biosimilar therapeutics-what do we need to consider?. NDT Plus 2009, 2(suppl 1):i27-i36.
-
(2009)
NDT Plus
, vol.2
, pp. i27-i36
-
-
Schellekens, H.1
-
33
-
-
84857899040
-
Risk management of biosimilars in oncology: each medicine is a work in progress
-
Vulto AG, Crow SA Risk management of biosimilars in oncology: each medicine is a work in progress. Target Oncol 2012, 7(suppl 1):S43-S49.
-
(2012)
Target Oncol
, vol.7
, pp. S43-S49
-
-
Vulto, A.G.1
Crow, S.A.2
-
34
-
-
77955551374
-
Risk management plans: are they a tool for improving drug safety?
-
Frau S, Font Pous M, Luppino MR, Conforti A Risk management plans: are they a tool for improving drug safety?. Eur J Clin Pharmacol 2010, 66:785-790.
-
(2010)
Eur J Clin Pharmacol
, vol.66
, pp. 785-790
-
-
Frau, S.1
Font Pous, M.2
Luppino, M.R.3
Conforti, A.4
-
35
-
-
54349091558
-
Safety-related regulatory actions for biologicals approved in the United States and the European Union
-
Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008, 300:1887-1896.
-
(2008)
JAMA
, vol.300
, pp. 1887-1896
-
-
Giezen, T.J.1
Mantel-Teeuwisse, A.K.2
Straus, S.M.3
Schellekens, H.4
Leufkens, H.G.5
Egberts, A.C.6
-
36
-
-
70449709036
-
Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval
-
Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Evaluation of post-authorization safety studies in the first cohort of EU Risk Management Plans at time of regulatory approval. Drug Saf 2009, 32:1175-1187.
-
(2009)
Drug Saf
, vol.32
, pp. 1175-1187
-
-
Giezen, T.J.1
Mantel-Teeuwisse, A.K.2
Straus, S.M.3
-
37
-
-
84955304390
-
-
(accessed May 5, 2015).
-
Lepage-Nefkens I, Gerkens S, Vinck I, Pierart J, Hulstaert F, Farfan-Portet M-I Chapter 6: International comparison of policies stimulating biosimilar uptake. Barriers and opportunities for the uptake of biosimilar medicines in Belgium. Belgian Health Care Knowledge Centre (accessed May 5, 2015). https://www.kce.fgov.be/sites/default/files/page_documents/KCE_199_2012-13-HSR_Biosimilars_report_0.pdf.
-
Chapter 6: International comparison of policies stimulating biosimilar uptake. Barriers and opportunities for the uptake of biosimilar medicines in Belgium. Belgian Health Care Knowledge Centre
-
-
Lepage-Nefkens, I.1
Gerkens, S.2
Vinck, I.3
Pierart, J.4
Hulstaert, F.5
Farfan-Portet, M.-I.6
-
38
-
-
84955297822
-
Barriers and opportunities for the uptake of biosimilar medicines in Belgium. Belgian Health Care Knowledge Centre
-
(accessed May 5, 2015).
-
Lepage-Nefkens I, Gerkens S, Vinck I, Pierart J, Hulstaert F, Farfan-Portet M-I Chapter 4: Biosimilars in the Belgian context. Barriers and opportunities for the uptake of biosimilar medicines in Belgium. Belgian Health Care Knowledge Centre (accessed May 5, 2015). https://www.kce.fgov.be/sites/default/files/page_documents/KCE_199_2012-13-HSR_Biosimilars_report_0.pdf.
-
Chapter 4: Biosimilars in the Belgian context
-
-
Lepage-Nefkens, I.1
Gerkens, S.2
Vinck, I.3
Pierart, J.4
Hulstaert, F.5
Farfan-Portet, M.-I.6
-
39
-
-
84856412542
-
Biosimilars: Price dynamics in Europe
-
Office of Health Economics, London, N. Mattison, J. Mestre-Ferrandiz, A. Towse (Eds.)
-
Liefner M Biosimilars: Price dynamics in Europe. Biosimilars: How much entry and price competition will result? 2010, Office of Health Economics, London. N. Mattison, J. Mestre-Ferrandiz, A. Towse (Eds.).
-
(2010)
Biosimilars: How much entry and price competition will result?
-
-
Liefner, M.1
-
40
-
-
85008248848
-
Biosimilars naming, label transparency, and authority of choice: survey findings among European physicians
-
Dolinar RO, Reilly MS Biosimilars naming, label transparency, and authority of choice: survey findings among European physicians. GaBI J 2014, 3:58-62.
-
(2014)
GaBI J
, vol.3
, pp. 58-62
-
-
Dolinar, R.O.1
Reilly, M.S.2
-
41
-
-
84889467547
-
-
Blackwell Publishing Ltd, Economic Policy, Hoboken
-
Kanavos P, Costa-Font J, Seeley E Competition in off-patent drug markets: issues, regulation and evidence 2009, 501-545. Blackwell Publishing Ltd, Economic Policy, Hoboken.
-
(2009)
Competition in off-patent drug markets: issues, regulation and evidence
, pp. 501-545
-
-
Kanavos, P.1
Costa-Font, J.2
Seeley, E.3
-
43
-
-
84955280743
-
-
Dutch Medicines Evaluation Board, (accessed May 25, 2015).
-
MEB position on prescription of "biosimilar medicinal products" Dutch Medicines Evaluation Board, (accessed May 25, 2015). http://www.cbg-meb.nl/CBG/en/human-medicines/actueel/150331_MEB_position_on_prescription_of_biosimilar_medicinal_products/default.htm.
-
MEB position on prescription of "biosimilar medicinal products"
-
-
-
44
-
-
84858713526
-
How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?
-
Dylst P, Vulto A, Simoens S How can pharmacist remuneration systems in Europe contribute to generic medicine dispensing?. Pharm Pract (Granada) 2012, 10:3-8.
-
(2012)
Pharm Pract (Granada)
, vol.10
, pp. 3-8
-
-
Dylst, P.1
Vulto, A.2
Simoens, S.3
-
46
-
-
84955254625
-
-
US Centers for Medicare and Medicaid Services, (accessed July 29, 2015).
-
Food and Drug Administration approval of first biosimilar product US Centers for Medicare and Medicaid Services, (accessed July 29, 2015). http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1509.pdf.
-
Food and Drug Administration approval of first biosimilar product
-
-
-
47
-
-
85008259058
-
What pricing and reimbursement policies to use for off-patent biologicals? Results from the EBE 2014 biological medicines policy survey
-
European Biopharmaceuticals Enterprise
-
What pricing and reimbursement policies to use for off-patent biologicals? Results from the EBE 2014 biological medicines policy survey. GaBI J 2015, 4:17-24. European Biopharmaceuticals Enterprise.
-
(2015)
GaBI J
, vol.4
, pp. 17-24
-
-
-
48
-
-
84955324424
-
-
PDCI Market Access, (accessed Aug 27, 2015).
-
International trends series part 4: uptake of biosimilars PDCI Market Access, (accessed Aug 27, 2015). http://www.pdci.ca/2015/05/26/pdci-international-trends-series-part-4.
-
International trends series part 4: uptake of biosimilars
-
-
-
49
-
-
84904023507
-
Barriers to the uptake of biosimilars and possible solutions: a Belgian case study
-
Dylst P, Vulto A, Simoens S Barriers to the uptake of biosimilars and possible solutions: a Belgian case study. Pharmacoeconomics 2014, 32:681-691.
-
(2014)
Pharmacoeconomics
, vol.32
, pp. 681-691
-
-
Dylst, P.1
Vulto, A.2
Simoens, S.3
-
50
-
-
84896281596
-
Regional tenders on biosimilars in Italy: potentially competitive?
-
Curto A, Van de Vooren K, Garattini L, Lo Muto R, Duranti S Regional tenders on biosimilars in Italy: potentially competitive?. GaBI J 2013, 2:123-129.
-
(2013)
GaBI J
, vol.2
, pp. 123-129
-
-
Curto, A.1
Van de Vooren, K.2
Garattini, L.3
Lo Muto, R.4
Duranti, S.5
-
51
-
-
84874472951
-
Biosimilars and market access: a question of comparability and costs?
-
Simoens S, Verbeken G, Huys I Biosimilars and market access: a question of comparability and costs?. Target Oncol 2012, 7:227-231.
-
(2012)
Target Oncol
, vol.7
, pp. 227-231
-
-
Simoens, S.1
Verbeken, G.2
Huys, I.3
-
52
-
-
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
-
53
-
-
84955243561
-
-
Norwegian Medicines Agency, (accessed April 23, 2015).
-
Guidelines for price setting in Norway Norwegian Medicines Agency, (accessed April 23, 2015). http://www.legemiddelverket.no/English/price:and_reimbursement/maximum-price/Documents/Guidelines%20for%20price%20setting%20in%20Norway%20oppdatert.docx.
-
Guidelines for price setting in Norway
-
-
-
54
-
-
84946942898
-
-
Agenzia Italiana del Farmaco, (accessed Aug 27, 2015).
-
AIFA position paper: i farmaci biosimilari Agenzia Italiana del Farmaco, (accessed Aug 27, 2015). http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf.
-
AIFA position paper: i farmaci biosimilari
-
-
-
55
-
-
79958039205
-
Reimbursement of pharmaceuticals: reference pricing versus health technology assessment
-
Drummond M, Jönsson B, Rutten F, Stargardt T Reimbursement of pharmaceuticals: reference pricing versus health technology assessment. Eur J Health Econ 2011, 12:263-271.
-
(2011)
Eur J Health Econ
, vol.12
, pp. 263-271
-
-
Drummond, M.1
Jönsson, B.2
Rutten, F.3
Stargardt, T.4
-
56
-
-
84955294951
-
-
Finance and NHS/Medicines, Pharmacy and Industry Group/17080Pharmacy and Industry Group/17080, UK Department of Health, London
-
The Pharmaceutical Price and Regulation Scheme 2014 2013, Finance and NHS/Medicines, Pharmacy and Industry Group/17080Pharmacy and Industry Group/17080, UK Department of Health, London.
-
(2013)
The Pharmaceutical Price and Regulation Scheme 2014
-
-
-
57
-
-
84955274931
-
-
Association of the British Pharmaceutical Industry, (accessed July 23, 2015).
-
Understanding the 2014 Pharmaceutical Price Regulation Scheme Association of the British Pharmaceutical Industry, (accessed July 23, 2015). http://www.abpi.org.uk/our-work/policy-parliamentary/Documents/understanding_pprs2014.pdf.
-
Understanding the 2014 Pharmaceutical Price Regulation Scheme
-
-
-
58
-
-
84955316886
-
World Preview 2014
-
EvaluatePharma, (accessed July 5, 2015).
-
World Preview 2014, Outlook to 2020 EvaluatePharma, (accessed July 5, 2015). http://info.evaluategroup.com/rs/evaluatepharmaltd/images/EP240614.pdf.
-
Outlook to 2020
-
-
-
59
-
-
84888391581
-
Developing oncology biosimilars: an essential approach for the future
-
Abraham J Developing oncology biosimilars: an essential approach for the future. Semin Oncol 2013, 40(suppl 1):S5-24.
-
(2013)
Semin Oncol
, vol.40
, pp. S5-24
-
-
Abraham, J.1
-
60
-
-
79961116944
-
Developing the nation's biosimilars program
-
Kozlowski S, Woodcock J, Midthun K, Sherman RB Developing the nation's biosimilars program. N Engl J Med 2011, 365:385-388.
-
(2011)
N Engl J Med
, vol.365
, pp. 385-388
-
-
Kozlowski, S.1
Woodcock, J.2
Midthun, K.3
Sherman, R.B.4
-
61
-
-
78049362302
-
-
Expert committee on biological standardization, World Health Organization, Geneva, (accessed June 23, 2015).
-
Guidelines on evaluation of similar biotherapeutic products (SBPs) 2009, Expert committee on biological standardization, World Health Organization, Geneva, (accessed June 23, 2015).
-
(2009)
Guidelines on evaluation of similar biotherapeutic products (SBPs)
-
-
-
63
-
-
84898023506
-
Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?
-
Farfan-Portet M-I, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?. Eur J Health Econ 2014, 15:223-228.
-
(2014)
Eur J Health Econ
, vol.15
, pp. 223-228
-
-
Farfan-Portet, M.-I.1
Gerkens, S.2
Lepage-Nefkens, I.3
Vinck, I.4
Hulstaert, F.5
-
64
-
-
84955244865
-
Biopharmaceutical industry pipeline for SEBs
-
Canadian Agency for Drugs and Technologies in Health, (accessed Feb 18, 2015).
-
Biopharmaceutical industry pipeline for SEBs. In: Subsequent entry biologics: emerging trends in regulatory and health technology assessment Canadian Agency for Drugs and Technologies in Health, (accessed Feb 18, 2015). http://www.cadth.ca/products/environmental-scanning/environmental-scans/environmental-scan-43.
-
Subsequent entry biologics: emerging trends in regulatory and health technology assessment
-
-
-
66
-
-
84923920535
-
New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer
-
Thill M New frontiers in oncology: biosimilar monoclonal antibodies for the treatment of breast cancer. Expert Rev Anticancer Ther 2015, 15:331-338.
-
(2015)
Expert Rev Anticancer Ther
, vol.15
, pp. 331-338
-
-
Thill, M.1
-
67
-
-
84923353114
-
Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation
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Scott BJ, Klein AV, Wang J Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation. J Clin Pharmacol 2015, 55(suppl 3):S123-S132.
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(2015)
J Clin Pharmacol
, vol.55
, pp. S123-S132
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Scott, B.J.1
Klein, A.V.2
Wang, J.3
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