-
1
-
-
84926407692
-
Why are cancer drugs so expensive in the United States, and what are the solutions?
-
1 Kantarjian, H, Rajkumar, SV, Why are cancer drugs so expensive in the United States, and what are the solutions?. Mayo Clin Proc 90 (2015), 500–504.
-
(2015)
Mayo Clin Proc
, vol.90
, pp. 500-504
-
-
Kantarjian, H.1
Rajkumar, S.V.2
-
2
-
-
84960503968
-
Understanding generic drugs
-
(accessed June 20, 2016).
-
2 Food and Drug Administration. Understanding generic drugs. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
3
-
-
84930248508
-
Generic drug market: growing and merging
-
3 The Lancet Oncology. Generic drug market: growing and merging. Lancet Oncol, 16, 2015, 595.
-
(2015)
Lancet Oncol
, vol.16
, pp. 595
-
-
-
4
-
-
84995664608
-
World oncology/cancer drugs market—opportunities and forecasts, 2013–2020
-
(accessed June 20, 2016).
-
4 Allied Market Research. World oncology/cancer drugs market—opportunities and forecasts, 2013–2020. http://www.alliedmarketresearch.com/oncology-cancer-drugs-market, 2015 (accessed June 20, 2016).
-
(2015)
-
-
-
5
-
-
83155188464
-
Drug shortages—a critical challenge for the generic-drug market
-
5 Chabner, BA, Drug shortages—a critical challenge for the generic-drug market. N Engl J Med 365 (2011), 2147–2149.
-
(2011)
N Engl J Med
, vol.365
, pp. 2147-2149
-
-
Chabner, B.A.1
-
6
-
-
84995659431
-
Top court in India rejects Novartis drug patent. The New York Times
-
(accessed June 20, 2016).
-
6 Harris, G, Top court in India rejects Novartis drug patent. The New York Times. http://www.nytimes.com/2013/04/02/business/global/top-court-in-india-rejects-novartis-drug-patent.html?_r=0, 2013 (accessed June 20, 2016).
-
(2013)
-
-
Harris, G.1
-
7
-
-
76049086281
-
-
Pearson Prentice Hall Upper Saddle River, NJ
-
7 Sullivan, A, Sheffrin, SM, Economics: principles in action, 2003, Pearson Prentice Hall, Upper Saddle River, NJ, 471.
-
(2003)
Economics: principles in action
, pp. 471
-
-
Sullivan, A.1
Sheffrin, S.M.2
-
8
-
-
84995663554
-
ICH Guidelines
-
(accessed June 20, 2016).
-
8 International Council for Harmonisation. ICH Guidelines. http://www.ich.org/products/guidelines, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
9
-
-
84975114815
-
About us
-
(accessed Oct 11, 2016).
-
9 International Generic Drug Regulators Programme. About us. http://www.igdrp.com/about-us, June, 2016 (accessed Oct 11, 2016).
-
(2016)
-
-
-
10
-
-
84976345284
-
Approved drug products with therapeutic equivalence evaluations
-
(accessed June 20, 2016).
-
10 Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. http://www.fda.gov/downloads/%20Drugs/DevelopmentApprovalProcess/UCM071436.pdf, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
11
-
-
84888009128
-
International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences
-
11 Davit, B, Braddy, AC, Conner, DP, Yu, LX, International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. AAPS J 15 (2013), 974–990.
-
(2013)
AAPS J
, vol.15
, pp. 974-990
-
-
Davit, B.1
Braddy, A.C.2
Conner, D.P.3
Yu, L.X.4
-
12
-
-
84995702573
-
China FDA lays down new guidelines on bioequivalence for generics
-
(accessed June 20, 2016).
-
12 Lane, EJ, China FDA lays down new guidelines on bioequivalence for generics. http://www.fiercepharma.com/manufacturing/china-fda-lays-down-new-guidelines-on-bioequivalence-for-generics, 2016 (accessed June 20, 2016).
-
(2016)
-
-
Lane, E.J.1
-
13
-
-
84995664607
-
India Central Drugs Standard Control Organization (CDSCO)
-
(accessed June 20, 2016).
-
13 India Central Drugs Standard Control Organization (CDSCO). http://www.cdsco.nic.in/forms/Default.aspx, 2014 (accessed June 20, 2016).
-
(2014)
-
-
-
14
-
-
84995569361
-
Notice: policy on bioequivalence standards for highly variable drug products
-
(accessed June 20, 2016).
-
14 Health Canada. Notice: policy on bioequivalence standards for highly variable drug products. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice-avis-be-hvdp-nb-pphv-eng.php, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
15
-
-
0343814361
-
Balancing competition and patent protection in the drug industry: The Drug Price Competition and Patent Term Restoration Act of 1984
-
15 Flannery, EJ, Hutt, PB, Balancing competition and patent protection in the drug industry: The Drug Price Competition and Patent Term Restoration Act of 1984. Food Drug Cosm Law J 40 (1985), 269–309.
-
(1985)
Food Drug Cosm Law J
, vol.40
, pp. 269-309
-
-
Flannery, E.J.1
Hutt, P.B.2
-
16
-
-
84963783385
-
Regulatory approval pathways for anticancer drugs in Japan, the EU and the US
-
16 Nagai, S, Ozawa, K, Regulatory approval pathways for anticancer drugs in Japan, the EU and the US. Int J Hematol 104 (2016), 73–84.
-
(2016)
Int J Hematol
, vol.104
, pp. 73-84
-
-
Nagai, S.1
Ozawa, K.2
-
17
-
-
84995650998
-
Promotion of the use of generic drugs
-
(accessed June 20, 2016).
-
17 Ministry of Health, Labour, and Welfare. Promotion of the use of generic drugs. http://www.mhlw.go.jp/english/policy_report/2012/09/120921.html, 2012 (accessed June 20, 2016).
-
(2012)
-
-
-
18
-
-
84939561957
-
Regulation of generic drugs in Japan: the current situation and future prospects
-
18 Kuribayashi, R, Matsuhama, M, Mikami, K, Regulation of generic drugs in Japan: the current situation and future prospects. AAPS J 17 (2015), 1312–1316.
-
(2015)
AAPS J
, vol.17
, pp. 1312-1316
-
-
Kuribayashi, R.1
Matsuhama, M.2
Mikami, K.3
-
19
-
-
79960309862
-
Guidance on the investigation of bioequivalence
-
(accessed June 20, 2016).
-
19 European Medicines Agency. Guidance on the investigation of bioequivalence. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf, 2010 (accessed June 20, 2016).
-
(2010)
-
-
-
20
-
-
84995551694
-
Regulatory process involved in generic drug approval process in USA, Europe and India
-
20 Suthakaran, R, Regulatory process involved in generic drug approval process in USA, Europe and India. Indo Am J Pharm Res 3 (2013), 1451–1456.
-
(2013)
Indo Am J Pharm Res
, vol.3
, pp. 1451-1456
-
-
Suthakaran, R.1
-
21
-
-
84995551693
-
State regulations on generic substitution
-
(accessed June 20, 2016).
-
21 Pharmacist's Letter. State regulations on generic substitution. http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?nidchk=1&cs=&s=PL&pt=2&segment=1186&dd=220901&AspxAutoDetectCookieSupport=1, 2009 (accessed June 20, 2016).
-
(2009)
-
-
-
22
-
-
84995686143
-
Condition-specific drug substitution legislation: epilepsy
-
(accessed June 20, 2016).
-
22 National Conference of State Legislatures. Condition-specific drug substitution legislation: epilepsy. http://www.ncsl.org/research/health/rx-substitution-by-pharmacists-state-legislation.aspx, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
23
-
-
84995684007
-
Generic imatinib: position of the CML society regarding the issue of generic imatinib in Canada
-
(accessed June 20, 2016).
-
23 The Chronic Myeloid Leukemia Society of Canada. Generic imatinib: position of the CML society regarding the issue of generic imatinib in Canada. http://cmlsociety.org/generic-tyrosine-kinase-inhibitors-tkis-arrive-in-canada/, 2012 (accessed June 20, 2016).
-
(2012)
-
-
-
24
-
-
84995606633
-
New generic substitution rules initiated in Japan
-
(accessed June 20, 2016).
-
24 Information Handling Services. New generic substitution rules initiated in Japan. http://www.ihs.com/country-industry-forecasting.html?ID=106596918, 2008 (accessed June 20, 2016).
-
(2008)
-
-
-
25
-
-
84858738931
-
Market review
-
(accessed June 20, 2016).
-
25 European Generic Medicines Association. Market review. http://www.aeseg.es/restringido2/Market%20Review%202011%20%282%29.pdf, 2011 (accessed June 20, 2016).
-
(2011)
-
-
-
26
-
-
84995606631
-
-
World Health Organization Geneva (accessed June 20, 2016).
-
26 WHO. Chinese pharmaceutical policy studies, 2004, World Health Organization, Geneva http://archives.who.int/tbs/ChinesePharmaceuticalPolicy/BackgroundENGdefault.htm (accessed June 20, 2016).
-
(2004)
Chinese pharmaceutical policy studies
-
-
-
27
-
-
79957570475
-
A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India
-
27 Singal, GL, Nanda, A, Kotwani, A, A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India. Ind J Pharmacol 43 (2011), 131–136.
-
(2011)
Ind J Pharmacol
, vol.43
, pp. 131-136
-
-
Singal, G.L.1
Nanda, A.2
Kotwani, A.3
-
28
-
-
84904872170
-
-
World Health Organization Geneva (accessed June 20, 2016).
-
28 Counterfeit medicines: frequently asked questions, 2009, World Health Organization, Geneva http://www.who.int/medicines/services/counterfeit/faqs/QACounterfeit-October2009.pdf (accessed June 20, 2016).
-
(2009)
Counterfeit medicines: frequently asked questions
-
-
-
29
-
-
78149358268
-
World drug report 2010
-
(accessed June 20, 2016).
-
29 United Nations Office on Drugs and Crime. World drug report 2010. http://www.unodc.org/documents/wdr/WDR_2010/World_Drug_Report_2010_lo-res.pdf, 2010 (accessed June 20, 2016).
-
(2010)
-
-
-
30
-
-
84904899403
-
Substandard drugs: a potential crisis for public health
-
30 Johnston, A, Holt, DW, Substandard drugs: a potential crisis for public health. Br J Clin Pharmacol 78 (2014), 218–243.
-
(2014)
Br J Clin Pharmacol
, vol.78
, pp. 218-243
-
-
Johnston, A.1
Holt, D.W.2
-
31
-
-
84865452198
-
Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States
-
31 Qureshi, ZP, Norris, L, Sartor, O, et al. Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States. J Oncol Pract 8 (2012), 84–90.
-
(2012)
J Oncol Pract
, vol.8
, pp. 84-90
-
-
Qureshi, Z.P.1
Norris, L.2
Sartor, O.3
-
32
-
-
84859058855
-
Counterfeit version of avastin in US distribution
-
(accessed June 20, 2016).
-
32 Food and Drug Administration. Counterfeit version of avastin in US distribution. http://www.fda.gov/Drugs/DrugSafety/ucm291960.htm, 2012 (accessed June 20, 2016).
-
(2012)
-
-
-
33
-
-
47949128986
-
Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis
-
33 Vial, J, Cohen, M, Sassiat, P, Thiébaut, D, Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Curr Med Res Opin 24 (2008), 2019–2033.
-
(2008)
Curr Med Res Opin
, vol.24
, pp. 2019-2033
-
-
Vial, J.1
Cohen, M.2
Sassiat, P.3
Thiébaut, D.4
-
34
-
-
84898685893
-
Comparison of serious adverse events between the original and a generic docetaxel in breast cancer patients
-
34 Poirier, E, Desbiens, C, Poirier, B, et al. Comparison of serious adverse events between the original and a generic docetaxel in breast cancer patients. Ann Pharmacother 48 (2014), 447–455.
-
(2014)
Ann Pharmacother
, vol.48
, pp. 447-455
-
-
Poirier, E.1
Desbiens, C.2
Poirier, B.3
-
35
-
-
84929950406
-
New cutaneous toxicities with generic docetaxel: are the excipients guilty?
-
35 Garrido-Siles, M, Arenas-Villafranca, JJ, Pérez-Ruiz, E, et al. New cutaneous toxicities with generic docetaxel: are the excipients guilty?. Support Care Cancer 23 (2015), 1917–1923.
-
(2015)
Support Care Cancer
, vol.23
, pp. 1917-1923
-
-
Garrido-Siles, M.1
Arenas-Villafranca, J.J.2
Pérez-Ruiz, E.3
-
36
-
-
84995551674
-
The “accidental” cure—platinum-based treatment for cancer: the discovery of cisplatin
-
(accessed June 20, 2016).
-
36 National Cancer Institute. The “accidental” cure—platinum-based treatment for cancer: the discovery of cisplatin. http://www.cancer.gov/research/progress/discovery/cisplatin, 2014 (accessed June 20, 2016).
-
(2014)
-
-
-
37
-
-
77956707516
-
Cisplatin and its analogues
-
V DeVita T Lawrence S Roesnberg 8th edn. Wolters Kluwer Lippincott Williams & Wilkins Philadelphia
-
37 Reed, E, Cisplatin and its analogues. DeVita, V, Lawrence, T, Roesnberg, S, (eds.) Cancer: principles and practice of oncology, 8th edn., 2008, Wolters Kluwer Lippincott Williams & Wilkins, Philadelphia, 419–426.
-
(2008)
Cancer: principles and practice of oncology
, pp. 419-426
-
-
Reed, E.1
-
38
-
-
84875791060
-
Renal toxicity caused by brand-name versus generic cisplatin: a comparative analysis
-
38 Niho, S, Yamanaka, T, Umemura, S, et al. Renal toxicity caused by brand-name versus generic cisplatin: a comparative analysis. Jpn J Clin Oncol 43 (2013), 390–395.
-
(2013)
Jpn J Clin Oncol
, vol.43
, pp. 390-395
-
-
Niho, S.1
Yamanaka, T.2
Umemura, S.3
-
39
-
-
78650207709
-
Innovator and generic cisplatin formulations: comparison of renal toxicity
-
39 Sekine, I, Kubota, K, Tamura, Y, et al. Innovator and generic cisplatin formulations: comparison of renal toxicity. Cancer Sci 102 (2011), 162–165.
-
(2011)
Cancer Sci
, vol.102
, pp. 162-165
-
-
Sekine, I.1
Kubota, K.2
Tamura, Y.3
-
40
-
-
84877790210
-
Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy
-
40 Oike, T, Ohno, T, Noda, SE, et al. Comparison of hematological toxicities between innovator and generic cisplatin formulations in cervical cancer patients treated with concurrent chemoradiotherapy. J Radiat Res 54 (2013), 474–478.
-
(2013)
J Radiat Res
, vol.54
, pp. 474-478
-
-
Oike, T.1
Ohno, T.2
Noda, S.E.3
-
41
-
-
0036795899
-
Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors
-
41 Dagher, R., Cohen, M, Williams, G, et al. Approval summary: imatinib mesylate in the treatment of metastatic and/or unresectable malignant gastrointestinal stromal tumors. Clin Cancer Res 8 (2002), 3034–3038.
-
(2002)
Clin Cancer Res
, vol.8
, pp. 3034-3038
-
-
Dagher, R.1
Cohen, M.2
Williams, G.3
-
42
-
-
84920538625
-
-
Teva-Canada Toronto, ON (accessed June 20, 2016).
-
42 Teva-Canada. TEVA-IMATINIB product monograph, 2013, Teva-Canada, Toronto, ON http://cmlsociety.org/wp-content/uploads/2013/10/TEVA-imatinib.pdf (accessed June 20, 2016).
-
(2013)
TEVA-IMATINIB product monograph
-
-
-
43
-
-
84920538624
-
-
Apotex Toronto, ON (accessed June 20, 2016).
-
43 Apotex. APO-IMATINIB product monograph, 2013, Apotex, Toronto, ON http://cmlsociety.org/wp-content/uploads/2013/10/APO-imatinib.pdf (accessed June 20, 2016).
-
(2013)
APO-IMATINIB product monograph
-
-
-
44
-
-
84995698121
-
-
Imatinib Teva London, UK (accessed June 20, 2016).
-
44 European Medicines Agency. European Medicines Agency assessment report, 2012, Imatinib Teva, London, UK http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002585/WC500137417.pdf (accessed June 20, 2016).
-
(2012)
European Medicines Agency assessment report
-
-
-
45
-
-
84978714596
-
-
Imatinib Actavis London, UK (accessed June 20, 2016).
-
45 European Medicines Agency. European Medicines Agency assessment report, 2014, Imatinib Actavis, London, UK http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/002594/WC500169745.pdf (accessed June 20, 2016).
-
(2014)
European Medicines Agency assessment report
-
-
-
46
-
-
84995681718
-
-
Imatinib Accord London, UK (accessed June 20, 2016).
-
46 European Medicines Agency. European Medicines Agency assessment report, 2013, Imatinib Accord, London, UK http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002681/WC500145560.pdf (accessed June 20, 2016).
-
(2013)
European Medicines Agency assessment report
-
-
-
47
-
-
84908876492
-
First line treatment of chronic phase chronic myeloid leukaemia patients with the generic formulations of imatinib mesylate
-
47 Eskazan, AE, Ayer, M, Kantarcioglu, B, et al. First line treatment of chronic phase chronic myeloid leukaemia patients with the generic formulations of imatinib mesylate. Br J Haematol 167 (2014), 139–141.
-
(2014)
Br J Haematol
, vol.167
, pp. 139-141
-
-
Eskazan, A.E.1
Ayer, M.2
Kantarcioglu, B.3
-
48
-
-
84925632459
-
What is the most cost-effective strategy for treating chronic myeloid leukemia after imatinib loses patent exclusivity in Europe?
-
48 Padula, WV, Conti, RM, Larson, RA, What is the most cost-effective strategy for treating chronic myeloid leukemia after imatinib loses patent exclusivity in Europe?. Blood, 124, 2014, 738.
-
(2014)
Blood
, vol.124
, pp. 738
-
-
Padula, W.V.1
Conti, R.M.2
Larson, R.A.3
-
49
-
-
84925940374
-
Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU
-
49 Conti, RM, Padula, WV, Larson, RA, Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. Ann Hematol 94 (2015), 249–257.
-
(2015)
Ann Hematol
, vol.94
, pp. 249-257
-
-
Conti, R.M.1
Padula, W.V.2
Larson, R.A.3
-
50
-
-
84995569371
-
Why chemotherapy that costs $70,000 in the US costs $2,500 in India?
-
(accessed June 20, 2016).
-
50 Bollyky, T, Why chemotherapy that costs $70,000 in the US costs $2,500 in India?. http://www.theatlantic.com/health/archive/2013/04/why-chemotherapy-that-costs-70-000-in-the-us-costs-2-500-in-india/274847/, 2013 (accessed June 20, 2016).
-
(2013)
-
-
Bollyky, T.1
-
51
-
-
84995551706
-
The arrival of generic imatinib into the US market: an educational event. The ASCO Post
-
(accessed June 20, 2016).
-
51 Kantarjian, H, The arrival of generic imatinib into the US market: an educational event. The ASCO Post. http://www.ascopost.com/issues/may-25-2016/the-arrival-of-generic-imatinib-into-the-us-market-an-educational-event/, 2016 (accessed June 20, 2016).
-
(2016)
-
-
Kantarjian, H.1
-
52
-
-
80052361457
-
Bioavailability of a new generic formulation of imatinib mesylate 400 mg tablets versus glivec in healthy male adult volunteers
-
52 Jawhari, D, Al Swisi, M, Ghannam, M, Bioavailability of a new generic formulation of imatinib mesylate 400 mg tablets versus glivec in healthy male adult volunteers. J Bioequiv Availab 3 (2012), 161–164.
-
(2012)
J Bioequiv Availab
, vol.3
, pp. 161-164
-
-
Jawhari, D.1
Al Swisi, M.2
Ghannam, M.3
-
53
-
-
84908871455
-
The efficacy of generic formulations of imatinib mesylate in the treatment of chronic myeloid leukemia
-
53 Eskazan, AE, Elverdi, T, Yalniz, FF, et al. The efficacy of generic formulations of imatinib mesylate in the treatment of chronic myeloid leukemia. Leuk Lymphoma 55 (2014), 2935–2937.
-
(2014)
Leuk Lymphoma
, vol.55
, pp. 2935-2937
-
-
Eskazan, A.E.1
Elverdi, T.2
Yalniz, F.F.3
-
54
-
-
84911369696
-
Deleterious effects of non-branded versions of imatinib used for the treatment of patients with chronic myeloid leukemia in chronic phase: a case series on an escalating issue impacting patient safety
-
54 Saveedra, D, Viscarra, F, Deleterious effects of non-branded versions of imatinib used for the treatment of patients with chronic myeloid leukemia in chronic phase: a case series on an escalating issue impacting patient safety. Leuk Lymphoma 55 (2014), 2813–2816.
-
(2014)
Leuk Lymphoma
, vol.55
, pp. 2813-2816
-
-
Saveedra, D.1
Viscarra, F.2
-
55
-
-
84911419543
-
Prospective single-center study of chronic myeloid leukemia in chronic phase: switching from branded imatinib to a copy drug and back
-
55 Alwan, AF, Matti, BF, Naji, AS, Muhammed, AH, Abdulsahib, MA, Prospective single-center study of chronic myeloid leukemia in chronic phase: switching from branded imatinib to a copy drug and back. Leuk Lymphoma 55 (2014), 2830–2834.
-
(2014)
Leuk Lymphoma
, vol.55
, pp. 2830-2834
-
-
Alwan, A.F.1
Matti, B.F.2
Naji, A.S.3
Muhammed, A.H.4
Abdulsahib, M.A.5
-
56
-
-
84995691418
-
Information on quality of generic drugs. Generic drug quality information study group meetings. July 10, 2008, to Sept 8, 2015)
-
(accessed June 20, 2016).
-
56 Pharmaceuticals and Medical Devices Agency. Information on quality of generic drugs. Generic drug quality information study group meetings. July 10, 2008, to Sept 8, 2015). http://www.pmda.go.jp/safety/info-services/drugs/calling-attention/generics-info/0004.html (accessed June 20, 2016).
-
-
-
-
57
-
-
84995698095
-
Examination of safety in changing from paraplatin for injection to carboplatin for intravenous infusion “NK”
-
(in Japanese).
-
57 Nishikawa, Y, Kajita, T, Kinezaki, M, et al. Examination of safety in changing from paraplatin for injection to carboplatin for intravenous infusion “NK”. Iryo Yakugaku 38 (2012), 708–714 (in Japanese).
-
(2012)
Iryo Yakugaku
, vol.38
, pp. 708-714
-
-
Nishikawa, Y.1
Kajita, T.2
Kinezaki, M.3
-
58
-
-
84995573340
-
Nephropathic comparison with the starting pharmaceutical products and generic medicine of cisplatin
-
(in Japanese).
-
58 Nephropathic comparison with the starting pharmaceutical products and generic medicine of cisplatin. J Jpn Soc Hosp Pharm 51 (2015), 41–44 (in Japanese).
-
(2015)
J Jpn Soc Hosp Pharm
, vol.51
, pp. 41-44
-
-
-
59
-
-
84995565797
-
Enforcement reports
-
(accessed June 20, 2016).
-
59 Food and Drug Administration. Enforcement reports. http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
60
-
-
85042649012
-
Recalls, market withdrawals, and safety alerts
-
(accessed June 20, 2016).
-
60 Food and Drug Administration. Recalls, market withdrawals, and safety alerts. http://www.fda.gov/Safety/Recalls/default.htm, 2016 (accessed June 20, 2016).
-
(2016)
-
-
-
61
-
-
84938415214
-
Definition and classification of generic drugs across the world
-
61 Alfonso-Cristancho, R, Andia, T, Barbosa, T, Watanabe, JH, Definition and classification of generic drugs across the world. Appl Health Econ Health Policy 13:suppl 1 (2015), S5–11.
-
(2015)
Appl Health Econ Health Policy
, vol.13
, pp. S5-11
-
-
Alfonso-Cristancho, R.1
Andia, T.2
Barbosa, T.3
Watanabe, J.H.4
-
62
-
-
84995686177
-
-
WHO/EMRO. Bioequivalence studies: regulatory requirements on conduct and documentation of BE. WHO Prequalification Programme on Priority Essential Medicines; Cairo, Egypt; June 6–7, 2007.
-
62 Rago L. WHO/EMRO. Bioequivalence studies: regulatory requirements on conduct and documentation of BE. WHO Prequalification Programme on Priority Essential Medicines; Cairo, Egypt; June 6–7, 2007.
-
-
-
Rago, L.1
-
63
-
-
84995702240
-
Warning letters and notice of violation letters to pharmaceutical companies
-
(accessed June 20, 2016).
-
63 Food and Drug Administration. Warning letters and notice of violation letters to pharmaceutical companies. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm380323.htm, 2014 (accessed June 20, 2016).
-
(2014)
-
-
-
64
-
-
84995663023
-
CDSCO plans surprise checks at drug manufacturing sites
-
(accessed June 20, 2016).
-
64 Raghavan, P, CDSCO plans surprise checks at drug manufacturing sites. http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/cdsco-plans-surprise-checks-at-drug-manufacturing-sites/articleshow/51577361.cms, 2016 (accessed June 20, 2016).
-
(2016)
-
-
Raghavan, P.1
-
65
-
-
84995569407
-
FDA increasing staffing in India, China
-
(accessed June 20, 2016).
-
65 Food and Drug Administration News. FDA increasing staffing in India, China. http://www.fdanews.com/articles/171724-fda-increasing-staffing-in-china-india?v=preview, 2015 (accessed June 20, 2016).
-
(2015)
-
-
-
66
-
-
84881305684
-
Securing the pharmaceutical supply chain
-
(accessed June 20, 2016).
-
66 Food and Drug Administration. Securing the pharmaceutical supply chain. http://www.fda.gov/NewsEvents/Testimony/ucm271073.htm, 2011 (accessed June 20, 2016).
-
(2011)
-
-
-
67
-
-
84995686181
-
Europe seeks drug suspensions
-
(accessed June 20, 2016).
-
67 Tremblay, J, Europe seeks drug suspensions. http://cen.acs.org/articles/93/web/2015/01/Europe-Seeks-Drug-Suspensions.html, 2015 (accessed June 20, 2016).
-
(2015)
-
-
Tremblay, J.1
-
68
-
-
84901443900
-
FDA devotes new resources to upgrading generic drug safety: but in some instances, the industry is pushing back
-
68 Barlas, S, FDA devotes new resources to upgrading generic drug safety: but in some instances, the industry is pushing back. P T 39 (2014), 353–364.
-
(2014)
P T
, vol.39
, pp. 353-364
-
-
Barlas, S.1
-
69
-
-
84905041512
-
Medicines made in India set off safety worries
-
(accessed June 20, 2016).
-
69 Harris, G, Medicines made in India set off safety worries. http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html, 2014 (accessed June 20, 2016).
-
(2014)
-
-
Harris, G.1
-
70
-
-
0345527019
-
Bioequivalence and other unresolved issues in generic drug substitution
-
70 Meredith, P, Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 25 (2003), 2875–2890.
-
(2003)
Clin Ther
, vol.25
, pp. 2875-2890
-
-
Meredith, P.1
-
71
-
-
84903468619
-
Drug-drug interactions with tyrosine-kinase inhibitors. A clinical perspective
-
71 Van Leeuwen, RW, Van Gelder, T, Mathijssen, RH, et al. Drug-drug interactions with tyrosine-kinase inhibitors. A clinical perspective. Lancet Oncol 15 (2014), e315–e326.
-
(2014)
Lancet Oncol
, vol.15
, pp. e315-e326
-
-
Van Leeuwen, R.W.1
Van Gelder, T.2
Mathijssen, R.H.3
-
72
-
-
84942368810
-
Product-specific regulatory pathways to approve generic drugs: the need for follow-up studies to ensure safety and effectiveness
-
72 Kesselheim, AS, Gagne, JJ, Product-specific regulatory pathways to approve generic drugs: the need for follow-up studies to ensure safety and effectiveness. Drug Saf 38 (2015), 849–853.
-
(2015)
Drug Saf
, vol.38
, pp. 849-853
-
-
Kesselheim, A.S.1
Gagne, J.J.2
-
73
-
-
84937142205
-
Global markets for generic drugs
-
(accessed June 20, 2016).
-
73 BCC Research LLC. Global markets for generic drugs. http://www.bccresearch.com/market-research/pharmaceuticals/generic-drugs-markets-phm009g.html, 2014 (accessed June 20, 2016).
-
(2014)
-
-
-
74
-
-
84962586667
-
Strategies that delay or prevent the timely availability of affordable generic drugs in the United States
-
74 Jones, GH, Carrier, MA, Silver, RT, Kantarjian, H, Strategies that delay or prevent the timely availability of affordable generic drugs in the United States. Blood 127 (2016), 1398–1402.
-
(2016)
Blood
, vol.127
, pp. 1398-1402
-
-
Jones, G.H.1
Carrier, M.A.2
Silver, R.T.3
Kantarjian, H.4
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