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Generic imatinib and original

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https://www.readbyqxmd.com/read/26924275/is-sunitinib-a-narrow-therapeutic-index-drug-a-systematic-review-and-in%C3%A2-vitro-toxicology-analysis-of-sunitinib-vs-imatinib-in-cells-from-different-tissues
#1
Bodo Haas, Konstantin Weber-Lassalle, Roland Frötschl, Niels Eckstein
Narrow Therapeutic Index Drugs (NTIDs) are characterized by a small range between therapeutic and toxicological effect. Missing international harmonized definition for NTIDs the EMA does not even have a definition of NTIDs in contrast to the U.S. FDA, Health Canada, and the Japanese NIHS. Sunitinib, a tyrosine kinase inhibitor (TKI), indicated for the treatment of certain cancer types, will be running off-patent soon. Falling into the category of NTID would have a major impact on regulatory requirements for generic applications...
June 2016: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/26594025/the-impact-of-new-generic-formulations-of-imatinib-mesylate-on-general-quality-of-life-in-chronic-phase-chronic-myeloid-leukaemia-patients
#2
Mehmet S Uyanik, Gulsum E Pamuk, Muhammet Maden, Elif Merev, Gokcen Cevik, Vesile Uyanik, Elif G Umit, Ahmet M Demir, Mustafa Akker
Treatment with tyrosine kinase inhibitors (TKIs) has dramatically changed the life expectancy of chronic myeloid leukaemia (CML) patients. Although the impact of first-generation TKIs on quality of life (QoL) was shown in CML, the effects of new generic formulations of imatinib mesylate (IM) are unclear. We evaluated differences in QoL under treatment with first- or second-generation TKIs. Fifty-two patients diagnosed with CP-CML completed the European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30, Hospital Anxiety and Depression Scale, and General Health Questionnaire...
November 23, 2015: European Journal of Cancer Care
https://www.readbyqxmd.com/read/25757922/comparative-study-of-the-anti-leukemic-effects-of-imatinib-mesylate-glivec%C3%A2-tablet-and-its-generic-formulation-ohk9511
#3
COMPARATIVE STUDY
Masako Yokoo, Yasushi Kubota, Yoko Tabe, Shinya Kimura
Long-term treatment with imatinib mesylate (IM) allows patients with chronic myeloid leukemia (CML) to live a near-normal lifespan. However, the fact that tyrosine kinase inhibitors, including IM, are extremely expensive is a major cause of poor adherence, resulting in disease relapse or drug resistance. Therefore, physicians are encouraged to prescribe generic drugs to reduce the financial burden of medical expenses. In Japan, only generic drugs that have a basic chemical structure and pharmacokinetic data that are the same as those of the original drug are approved...
2015: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/24516297/chronic-myeloid-leukemia-data-from-india
#4
Shweta Bansal, Kumar Prabhash, Purvish Parikh
In an effort to collaborate the data of chronic myeloid leukemia (CML) patient from all over India,meeting was conceived by ICON (Indian Cooperative Oncology Network) in 2010. This article presents the summarized picture of the data presented in the meeting. In the meeting 8115 patients data was presented and 18 centres submitted their manuscripts comprising of 6677 patients. This data represents large series of patients from all over the country treated on day to day clinical practice and presents the actual outcomes of CML patients in India...
July 2013: Indian Journal of Medical and Paediatric Oncology
https://www.readbyqxmd.com/read/22265076/impact-of-the-introduction-of-government-use-licenses-on-the-drug-expenditure-on-seven-medicines-in-thailand
#5
Adun Mohara, Inthira Yamabhai, Kakanang Chaisiri, Sripen Tantivess, Yot Teerawattananon
OBJECTIVES: To assess the budget impact of the government use licenses policy, a form of compulsory licensing used by the government, on seven patented drugs, namely, efavirenz, lopinavir/ritonavir combination, clopidogrel, letrozole, docetaxel, erlotinib, and imatinib, in Thailand between 2006 and 2008. METHODS: By using government's perspective, budget impact was estimated within a 5-year period after the introduction of the policy. The number of patients who need treatment with each drug and the costs of treatments by both original and generic versions were obtained from Thai government agencies...
January 2012: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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