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Imatinib and bioequivalence

J Kong, N Chen, H X Fu, T J Hang, M Song, H Jiang
Objective: To evaluate the pharmacokinetics and bioequivalence of generic dasatinib in patients with chronic myeloid leukemia in the choronie phase (CML-CP). Methods: Using randomized, parallel, overlapping, self-control designed study, a 100 mg dose of the reference or test tablet was given to 12 CML-CP patients who were resistant or intolerant to Imatinib and Nilotinib in a randomized two-way crossover design, and the plasma concentration of the medicine was assayed by HPLC-MS-MS. The main pharmacokinetic parameters and bioequivalence of the two formulations were evaluated...
November 14, 2016: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
Y Tony Yang, Sumimasa Nagai, Brian K Chen, Zaina P Qureshi, Akida A Lebby, Samuel Kessler, Peter Georgantopoulos, Dennis W Raisch, Oliver Sartor, Terhi Hermanson, Robert C Kane, William J Hrushesky, Joshua J Riente, LeAnn B Norris, Laura R Bobolts, James O Armitage, Charles L Bennett
Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel)...
November 2016: Lancet Oncology
Alen Ostojic, Dubravka Sertic, Pavle Roncevic, Zinaida Peric, Paula Granic, Nikolina Matic, Sandra Basic-Kinda, Ranka Serventi-Seiwerth, Ivo Radman, Renata Zadro, Damir Nemet
INTRODUCTION: For over a decade, imatinib has been the first-line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). Doubts on the bioequivalence and bioavailability of emerging generic compounds have been expressed. Adequate imatinib plasma concentration ([IPC] ≥1000 μmol/L) is associated with a better chance of optimal treatment response in patients with CML. In this study, we compared the achieved IPCs between the branded compound and its 2 generic forms...
August 2016: Clinical Lymphoma, Myeloma & Leukemia
Rachna Arora, Manju Sharma, Tausif Monif, Sunil Iyer
PURPOSE: This study was designed to characterize the pharmacokinetic profile and to assess bioequivalence of the sponsor's test formulation (imatinib mesylate 400 mg tablets) with an innovator product (Gleevec 400 mg tablets, Novartis Pharmaceuticals) under fed conditions, in adult patients of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) stabilized on imatinib mesylate 400 mg. In addition, the aim of this study was to monitor the safety profile of investigational medicinal products (IMPs)...
July 2016: Cancer Research and Treatment: Official Journal of Korean Cancer Association
Ehsan Mohajeri, Behjat Kalantari-Khandani, Abbas Pardakhty, Moeinadin Safavi, Mehdi Ansari
BACKGROUND: Imatinib is known as the drug of choice for treatment of chronic myeloid leukemia (CML). For adults the recommended daily dosage of 400 mg requires simultaneous intake of up to four capsules or tablets each 100 mg. A new 400 mg film coated tablet developed due to the need to swallow multiple capsules or tablets per dose and that was a negative impact on treatment adherence. SUBJECTS AND METHODS: A group of 36 patients were randomly assigned to receive Imatinib as 4×100 mg capsules, 4×100 mg tablets and 1×400 mg tablet...
October 1, 2015: International Journal of Hematology-oncology and Stem Cell Research
Ali-Akbar Golabchifar, Saeed Rezaee, Nahid Mobarghei Dinan, Abbas Kebriaeezadeh, Mohammad-Reza Rouini
BACKGROUND AND OBJECTIVE: Imatinib mesylate is presently the first-line treatment for chronic myeloid leukemia (CML). The aim of this study was to investigate the absorption and distribution kinetics of imatinib in healthy Iranian volunteers using nonlinear mixed effects modeling (NLMEM) to assess the overall, intra- and inter-subject variabilities in pharmacokinetic parameters after oral administration. METHODS: This analysis was based on data from 24 healthy subjects who participated in a bioequivalence study after administering a single dose of 200 mg of each formulation...
October 2016: European Journal of Drug Metabolism and Pharmacokinetics
Hae Won Lee, Sook Jin Seong, Sung Min Park, Joomi Lee, Mi-Ri Gwon, Hyun-Ju Kim, Sung Mook Lim, Mi-Sun Lim, Woomi Kim, Dong Heon Yang, Young-Ran Yoon
BACKGROUND: Imatinib mesylate (IM) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. A new once-daily 400-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea. OBJECTIVE: The present study was designed to assess and compare the PK parameters, bioavailability, and bioequivalence of the new imatinib 400-mg formulation (test) versus the conventional 100-mg formulation (reference) administered as a single 400-mg dose in healthy adult male volunteers...
June 2015: International Journal of Clinical Pharmacology and Therapeutics
Andrzej Ostrowicz, Przemysław L Mikołajczak, Marzena Wierzbicka, Piotr Boguradzki
The aim of the study was to investigate the bioavailability of a generic product of 100 mg and 400 mg imatinib film-coated tablets (test) as compared to that of a branded product (reference) at the same strength to determine bioequivalence. The secondary objective of the study was to evaluate tolerability of both products. An open-label, randomized, crossover, two-period, single-dose, comparative study was conducted in 43 (Imatynib-Biofarm 100 mg film-coated tablet) and in 42 (Imatynib-Biofarm 400 mg film-coated tablet), brand name Imatenil, Caucasian healthy volunteers in fed conditions...
September 2014: Acta Poloniae Pharmaceutica
Mario L de Lemos, Victoria Kyritsis
BACKGROUND: Generic imatinib has recently been approved for chronic myeloid leukemia in Canada and the European Union (EU). There are anecdotal concerns of reduced efficacy related to generic vs. brand name imatinib. METHODS: MEDLINE and EMBASE were searched. Generic imatinib product monographs approved by Health Canada and the European Medicines Agency (EMA) were reviewed. Medical information of Novartis, Teva and Apotex were contacted. RESULTS: Several issues have been raised...
February 2015: Journal of Oncology Pharmacy Practice
J A Jung, N Kim, J-S Yang, T-e Kim, J-R Kim, G-S Song, H Kim, J W Ko, W Huh
Imatinib mesylate is effective for chronic myeloid leukaemia and gastrointestinal tumours. We aimed to evaluate the pharmacokinetics of a 200-mg imatinib tablet compared to 2×100-mg imatinib tablets in order to meet the regulatory requirements for marketing in Korea.An open-label, randomized, single-dose, 2-period, 2-treatment cross-over study was conducted in 28 healthy Korean male volunteers. Subjects were administered a 200-mg imatinib tablet and 2×100-mg imatinib tablets under a fasting state according to a randomly assigned order with a 2-week wash-out period...
December 2014: Drug Research
Anna Kaltenboeck, Genia Long, Eleanor Hayes-Larson, Gilberto de Lima Lopes
Access to safe, high-quality medicines is an important international healthcare issue. In developing countries, copy medicines may be attractive due to low acquisition price, but their potential risks due to inadequately demonstrated bioequivalence have garnered only limited attention. As a result, policy-makers, physicians and patients may have incomplete information regarding their real-world safety and efficacy. Using chronic myeloid leukemia (CML) treatment as an example, we conducted a literature review of case reports and study publications to assess whether the available literature provides evidence on the real-world safety and efficacy of imatinib copies...
November 2013: Expert Review of Clinical Pharmacology
Vinicius Marcondes Rezende, Ariane Rivellis, Mafalda Megumi Yoshinaga Novaes, Dalton de Alencar Fisher Chamone, Israel Bendit
BACKGROUND: Imatinib mesylate has been a breakthrough treatment for chronic myeloid leukemia. It has become the ideal tyrosine kinase inhibitor and the standard treatment for chronic-phase leukemia. Striking results have recently been reported, but intolerance to imatinib and noncompliance with treatment remain to be solved. Molecular monitoring by quantitative real-time polymerase chain reaction is the gold standard for monitoring patients, and imatinib blood levels have also become an important tool for monitoring...
2013: Drug Design, Development and Therapy
Susana Parrillo-Campiglia, Mónica Cedres Ercoli, Ofelia Umpierrez, Patricia Rodríguez, Sara Márquez, Carolina Guarneri, Francisco T Estevez-Parrillo, Marilena Laurenz, Francisco E Estevez-Carrizo
BACKGROUND: Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. OBJECTIVE: The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg...
October 2009: Clinical Therapeutics
Zariana Nikolova, Bin Peng, Martine Hubert, Michael Sieberling, Urs Keller, Yu-Yun Ho, Horst Schran, Renaud Capdeville
PURPOSE: Imatinib (Glivec) has been established as a highly effective therapy for chronic myeloid leukemia and gastrointestinal tumors. The recommended daily dosage of 400-600 mg requires simultaneous intake of up to six of the current 100-mg capsules. Due to the need to swallow multiple capsules per dose, there is a potential negative impact on treatment adherence; therefore, a new imatinib 400-mg film-coated tablet has been developed. To improve dosing flexibility, particularly with regard to the pediatric population and the management of adverse events, a scored 100-mg film-coated tablet has also been introduced...
May 2004: Cancer Chemotherapy and Pharmacology
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