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International Journal of Clinical Pharmacology and Therapeutics

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https://www.readbyqxmd.com/read/27900937/post-authorization-changes-in-the-safety-and-efficacy-assessment-recommended-indications-and-drug-quality-profile-of-adalimumab-a-chronological-overview
#1
Gergely Iványi, Romána Zelkó
OBJECTIVE: The intention of the present study was to demonstrate the postauthorization changes of adalimumab (European trade name: Humira), evaluating the variations in its safety, efficacy, and quality profile. METHODS: Type-II, major variations of the Summary of Product Characteristics (SmPC) from September 8, 2003 to November 19, 2015, were analyzed, which, according to Commission Regulation (EC) No. 1234/2008, have to reflect changes that may have a significant impact on the safety, efficacy, or quality profile of a medicinal product...
November 30, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879196/treatment-persistence-in-the-use-of-basal-insulins-in-poland-and-germany%C3%A2
#2
Wolfgang Rathmann, Marcin Czech, Edward Franek, Karel Kostev
AIMS: To compare short-term basal insulin therapy persistence and its predictors in Poland and Germany. METHODS: Persistence was defined as proportions of patients remaining on the initial basal insulin (analogs: Poland: n = 6,889, Germany: n = 454,067; neutral protamine Hagedorn (NPH) insulins: Poland: n = 50,761, Germany: n = 226,064) over 2 years based on nationwide prescription databases (LRx; IMS Health) in Poland and Germany from 2013 to 2015. Persistence was evaluated by Kaplan-Meier curves (log-rank tests)...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879195/the-pharmacokinetic-comparison-and-bioequivalence-evaluation-of-two-10-mg-baclofen-formulations-in-healthy-male-subjects%C3%A2
#3
Sumin Yoon, SeungHwan Lee, Kyung-Sang Yu, Sung-Vin Yim, Bo-Hyung Kim
BACKGROUNDS: Baclofen is used as a skeletal muscle relaxant for multiple sclerosis patients. It depresses the transmission of monosynaptic and polysynaptic reflex by stimulating GABAβ (gamma-aminobutyric acid) receptors. OBJECTIVES: The aim of this study was to compare the pharmacokinetic characteristics of two 10-mg baclofen formulations and to assess bioequivalence. METHODS: A randomized, single-dose, two-period, two-sequence crossover study was conducted in healthy male subjects...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879194/prescription-patterns-and-drug-costs-in-german-patients-with-dementia-in-nursing-homes-and-home-care-settings%C3%A2
#4
Louis Jacob, Jens Bohlken, Karel Kostev
AIMS: To analyze prescription patterns and drug costs in German patients with dementia who are in home-care settings and nursing homes. METHODS: The present retrospective study based on the Disease Analyzer epidemiological database and included 41,064 patients treated by general practitioners (GPs) and 20,649 patients treated by psychiatric practitioners (PPs), who were diagnosed with dementia in 2014. Four different types of antidementia therapy were included in the analysis...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879193/pharmacokinetic-comparison-of-two-formulations-of-talniflumate-370%C3%A2-mg-tablets-in-healthy-korean-volunteers%C3%A2
#5
Yun Kim, Sung- Yim, Bo-Hyung Kim, SeungHwan Lee
BACKGROUND: Talniflumate, a prodrug of niflumic acid, is a potent analgesic and anti-inflammatory drug that has been widely used for the treatment of rheumatoid diseases. OBJECTIVE: The aim of this study was to compare the pharmacokinetics and to evaluate the bioequivalence of two formulations of talniflumate 370 mg tablets (test formulation: Flumagen® 370 mg tablet; reference formulation: Somalgen® 370 mg tablet). METHODS: A randomized, open-label, single dose, two-sequence, two-period crossover clinical study was conducted...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879192/n-terminal-probrain-natriuretic-peptide-in-patients-with-acute-coronary-syndrome%C3%A2
#6
Qi Kang, Zheng Wan, Zhenwen Huang
OBJECTIVE: To observe the changes and evaluate the significance of serum N-terminal probrain natriuretic peptide (NT-proBNP) levels in patients with acute coronary syndrome and to discuss its clinical significance and relationship with the severity of disease. METHODS: Serum NT-proBNP levels were determined rapidly by using the triage BNP test for 98 consecutive patients with coronary heart disease (CAD) admitted to the hospital from March 2013 to December 2013; the correlation between the concentration of NT-proBNP and the degree of severity of the disease was analyzed...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27879191/replacement-of-sfc-dpi-with-sfc-mdi-exhaled-through-the-nose-improved-eosinophilic-chronic-rhinosinusitis-with-bronchial-asthma%C3%A2
#7
Yoshiki Kobayashi, Mikiya Asako, Takahisa Yamamoto, Hirotaka Yasuba, Koichi Tomoda, Akira Kanda
OBJECTIVE: Eosinophilic chronic rhinosinusitis (ECRS), a subgroup of chronic rhinosinusitis with nasal polyps, is a refractory disease closely associated with bronchial asthma. We recently reported on the efficacy of ultra-fine particle inhaled corticosteroids (ICS) (hydrofluoroalkane-134a-beclomethasone dipropionate: HFA-BDP) exhalation through the nose (ETN) treatment for mild-to-moderate asthmatics with ECRS. However, the effect of HFA-BDP ETN was found to be transient in some cases with severe ECRS and asthma, requiring treatment with higher-dose ICS and long-acting β2-agonists (LABA)...
November 23, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841155/pharmacokinetics-and-safety-of-the-selective-progesterone-receptor-modulator-vilaprisan-in-healthy-postmenopausal-women%C3%A2
#8
Marcus-Hillert Schultze-Mosgau, Barbara Schuett, Frank-Thorsten Hafner, Frank Zollmann, Andreas Kaiser, Joachim Hoechel, Beate Rohde
OBJECTIVES: Vilaprisan is a novel, potent, and highly selective progesterone receptor modulator, which might offer a promising option for the treatment of uterine fibroids. METHODS AND MATERIALS: In this randomized, placebo-controlled, parallel-group phase 1 study, the pharmacokinetics and safety of vilaprisan were investigated in healthy postmenopausal women. Subjects received a single oral dose of vilaprisan (1, 5, 15, or 30 mg) or placebo and - after a wash-out period - daily doses of the same strength over 28 days...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841154/utilization-of-population-pharmacokinetics-in-drug-development-and-provision-of-the-results-to-healthcare-professionals%C3%A2
#9
Megumi Watanabe-Uchida, Mamoru Narukawa
OBJECTIVE: The aim of this research is to understand the level of utilization of population pharmacokinetics (PPK) in drug development in the United States of America (US) and Japan, and to discuss what kind of PPK information should be provided to healthcare professionals. METHODS: Information on PPK was identified on the label, package insert, and pharmaceutical evaluation report disclosed by the US Food and Drug Administration and the Pharmaceutical Medical Devices Agency of Japan for new molecular entities approved between January 2012 and December 2015...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841153/comparative-pharmacokinetic-and-bioequivalence-evaluation-of-two-formulations-of-morniflumate-350-mg-tablets-in-healthy-male-subjects%C3%A2
#10
Heechan Lee, Sung-Vin Yim, Bo-Hyung Kim, SeungHwan Lee
BACKGROUND: Morniflumate is a nonsteroid anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-1, 2 (COX-1, 2). OBJECTIVE: This study aimed to compare the pharmacokinetics (PKs) and assess the bioequivalence of two different formulations of morniflumate 350-mg tablets in healthy Korean male subjects. METHODS: A randomized, single-dose, two-period, two-sequence crossover study was conducted with 38 subjects. Subjects received a single dose of two tablets of either a test or a reference formulation and the alternated formulation in the next period...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841152/pharmacokinetics-and-safety-of-indacaterol-and-glycopyrronium-ind-gly-following-repeated-once-daily-inhalation-from-a-fixed-dose-combination-in-healthy-chinese-subjects%C3%A2
#11
Shuang Ren, Romain Sechaud, Zhenzhong Su, Hanns-Christian Tillmann, Hisanori Hara, Xuemei Tan, Jie Hou, Ralph Woessner, Rong Zhao
OBJECTIVE: Indacaterol/glycopyrronium (IND/GLY) is a once-daily fixed-dose combination of two long-acting bronchodilators: indacaterol 110 µg (long-acting β2-adrenergic agonist, LABA) and glycopyrronium 50 µg (long-acting muscarinic antagonist, LAMA). This study assessed the pharmacokinetics of IND/GLY 110/50 µg following multiple once-daily inhaled administrations in healthy Chinese subjects. METHODS: This was a single-centre, open-label, multiple-dose study of inhaled IND/GLY delivered via the Breezhaler® device...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841151/pharmacokinetics-safety-and-tolerability-of-siponimod-baf312-in-subjects-with-severe-renal-impairment-a-single-dose-open-label-parallel-group-study%C3%A2
#12
Anne Gardin, Angela Dodman, Sampath Kalluri, Srikanth Neelakantham, Xuemei Tan, Eric Legangneux, Kasra Shakeri-Nejad
OBJECTIVE: To investigate the pharmacokinetics (PK), safety, and tolerability of siponimod and selected inactive metabolites (M3 and M5) in subjects with varying degrees of renal impairment (RI) compared to demographically matched healthy subjects (HS). METHODS: The study enrolled subjects with severe RI (n = 8) and matched HS (n = 8). Subjects with moderate and mild RI were to be enrolled only if interim analysis showed ≥ 50% increase in maximum plasma concentration (Cmax) or area under the curve (AUC) of total and/or unbound siponimod in severe RI subjects vs...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841150/cyp3a4-1g-and-cyp3a5-3-genetic-polymorphisms-alter-the-antihypertensive-efficacy-of-amlodipine-in-patients-with-hypertension-following-renal-transplantation%C3%A2
#13
Yun Huang, Gaiyan Wen, Yao Lu, Jia Wen, Ying Ji, Xiaowei Xing, Ying Li, Juan Wen, Hong Yuan
OBJECTIVE: Previous studies have determined that CYP3A and multidrug resistance protein 1 (MDR1) polymorphisms can affect the pharmacokinetics and pharmacodynamics of amlodipine in both healthy subjects and those with early hypertensive renal disease. In the current study, our objective was to analyze the association between the CYP3A4*1G, CYP3A5*3, and MDR1 C3435T gene polymorphisms and the antihypertensive efficacy of amlodipine in hypertensive patients after renal transplantation. MATERIALS: Blood samples were collected from 76 patients on amlodipine therapy (5 mg/d)...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27841149/warfarin-dose-requirements-with-different-genotypes-of-and-for-patients-with-atrial-fibrillation-and-valve-replacement%C3%A2
#14
Weirong Chen, Luhua Wu, Xin Liu, Yue Shen, Yan Liang, Jun Zhu, Huiqiong Tan, Yanmin Yang, Qun Liu, Mingsheng Wang, Lisheng Liu, Xingyu Wang
AIMS: To investigate whether genetic variants of CYP2C9 and VKORC1 have different effects on the dose of warfarin in 180 Han Chinese patients who were recruited from the Fu Wai Hospital. All were on maintenance treatment with stable daily warfarin doses for a period of at least 3 months. METHODS: DNA was isolated and genotyped using a Warfarin dosage Prediction Kit for single nucleotide polymorphisms (SNPs) of CYP2C9 and VKORC1. RESULTS: The VKORC1 and CYP2C9*3 polymorphisms are significantly associated with warfarin maintenance dosages...
November 14, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27781422/evaluation-of-area-under-the-curve-of-enteric-coated-mycophenolate-sodium-by-limited-sampling-strategy-in-chinese-kidney-transplant-recipients%C3%A2
#15
Hongfeng Huang, Xi Yao, Jianyong Wu, Wenhan Peng, Jianghua Chen
AIMS: To investigate the area under the curve (AUC) of mycophenolic acid (MPA) in adult Chinese renal allograft recipients receiving concomitant enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine (CsA) during the early post-transplant phase and to develop optimal model equations for estimation of the MPA area under the plasma concentration-time curve from 0 to 12 hours (AUC0-12h) using a limited-sampling strategy (LSS). METHODS: The present study enrolled 24 Chinese renal recipients treated with EC-MPS, CsA, and corticosteroid, from whom 24 serial blood samples were collected over 12 hours...
October 26, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27781420/circadian-pharmacokinetics-and-limited-sampling-strategy-of-everolimus-in-heart-transplant-patients%C3%A2
#16
Yuka Terada, Kyoichi Wada, Sachi Matsuda, Takeshi Kuwahara, Atsufumi Kawabata, Mitsutaka Takada, Takuya Watanabe, Seiko Nakajima, Takuma Sato, Osamu Seguchi, Masanobu Yanase, Norihide Fukushima, Takeshi Nakatani
OBJECTIVE: To evaluate circadian changes in everolimus (EVL) pharmacokinetics and to identify the time point of blood sampling with the strongest correlation with the area under the blood concentration-time curve (AUC) of EVL in heart transplant patients. METHODS: Heart transplant patients receiving the same dose of EVL twice a day were reviewed. In 28 patients enrolled, whole blood samples were collected before (C0), and 1, 2, 4, 6, 8, and 12 hours after each administration of EVL...
October 26, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27719742/blood-lipid-abnormality-changes-the-rate-of-alveolar-capillary-uptake-of-sevoflurane-a-prospective-non-interventional-clinical-study%C3%A2
#17
YanQiu Liu, YiMin Ren, Hong Gao, Li Zeng, ShaoFeng Lin, KaiQiang Zhang
OBJECTIVE: This research studied the influence of different blood lipid components on the rate of alveolar-capillary uptake of sevoflurane. METHOD: 104 patients aged 20 - 50 years undergoing elective operations under general anesthesia were mechanically ventilated through endotracheal intubation after intravenous injections of midazolam, vecuronium, fentanyl, and etomidate. They inhaled 2% sevoflurane at an oxygen flow of 2 L/min, then the inspired concentrations (FI) and expired concentrations (FA of sevoflurane were recorded at 1, 3, 5, 7, 10, 15, 20, and 30 minutes...
October 10, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27719740/berberine-promotes-antiproliferative-effects-of-epirubicin-in-t24-bladder-cancer-cells-by-enhancing-apoptosis-and-cell-cycle-arrest%C3%A2
#18
Yumin Zhuo, Qibiao Chen, Bo Chen, Xiongyu Zhan, Xiaoping Qin, Jun Huang, Xiuxiu Lv
OBJECTIVE: The present study was aimed to observe the effect of berberine (Ber) on epirubicin (EPI)-induced growth inhibition, apoptosis, and cell cycle arrest in T24 bladder cancer cells. METHODS: The cancer cells were exposed to EPI, with or without different concentrations of Ber. The viability of the cancer cells was measured by cell counting Kit-8, the apoptosis was determined by Hoechst 33258 staining and the expression of cleaved caspase-3, cleaved caspase-9, Bcl-2, Bax, and P53 proteins were detected by Western blot assay...
October 10, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27641218/usefulness-of-thyroglobulin-in-cervical-lymph-node-fine-needle-aspirations-for-the-diagnosis-of-metastases-from-papillary-thyroid-cancer-at-initial-thyroidectomy%C3%A2
#19
Jing Yu, Yanpeng Song, Zhibing Jiang
OBJECTIVE: To study the role of fine-needle aspiration biopsy and thyroglobulin measurement (FNAB-Tg) in diagnosing cervical lymph node (CLN) metastases in patients with papillary thyroid cancer (PTC) before thyroidectomy. METHODS: Ultrasonography (US)-guided FNAB was performed on 92 patients with PTCs with 105 CLNs before surgery. The wash-out of the FNAB-Tg level was detected. RESULTS: Based on the final pathology, 67 lymph nodes (LNs) were positive for metastasis, and 38 LNs were negative for metastasis...
September 19, 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27641216/agonistic-anti-cd40-therapy-synergizes-with-lag-3-blocking-antibodies%C3%A2
#20
Philipp Müller, Daniela S Thommen, Alfred Zippelius
No abstract text is available yet for this article.
September 19, 2016: International Journal of Clinical Pharmacology and Therapeutics
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