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Pharmacokinetic

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https://www.readbyqxmd.com/read/29667921/glycemic-control-of-type-2-diabetes-mellitus-across-stages-of-renal-impairment-information-for-primary-care-providers
#1
Lili Tong, Sharon Adler
Chronic kidney disease (CKD) is a frequent complication of type 2 diabetes mellitus (T2DM) and elevates individuals' risk for cardiovascular disease, the leading cause of morbidity and mortality in T2DM. Achieving and maintaining tight glycemic control is key to preventing development or progression of CKD; however, improving glycemic control may be limited by effects of renal impairment on the efficacy and safety of T2DM treatments, necessitating dosing adjustments and careful evaluation of contraindications...
April 18, 2018: Postgraduate Medicine
https://www.readbyqxmd.com/read/29667896/a-phase-1-study-to-assess-the-pharmacokinetics-safety-and-tolerability-of-fremanezumab-doses-225-mg-675-mg-and-900-mg-in-japanese-and-caucasian-healthy-subjects
#2
Orit Cohen-Barak, Sivan Weiss, Michele Rasamoelisolo, Nicola Faulhaber, Paul P Yeung, Pippa S Loupe, Esther Yoon, Mohit D Gandhi, Ofer Spiegelstein, Ernesto Aycardi
Objectives The primary and secondary objectives of this phase 1 study were to evaluate the pharmacokinetic profile, safety, and immunogenicity of fremanezumab subcutaneous (sc) doses tested in phase 2 and 3 trials (225 mg, 675 mg and 900 mg) following single administration in Japanese (n = 32) and Caucasian (n = 32) healthy subjects. Methods Japanese and matched Caucasian healthy subjects were enrolled into one of four cohorts and were randomly assigned to one of four treatments: 225, 675, or 900 mg fremanezumab, or placebo...
January 1, 2018: Cephalalgia: An International Journal of Headache
https://www.readbyqxmd.com/read/29667756/pharmacokinetic-profiling-of-anticancer-phytocompounds-using-computational-approach
#3
Ashish Sharma, Shilpa Sharma, Mansi Gupta, Shehnaz Fatima, Ravi Saini, Subhash Mohan Agarwal
INTRODUCTION: Natural products exhibit diverse scaffolds and are considered as suitable candidates for development of leads. However, poor pharmacokinetics often acts as a hindrance during the drug discovery process. OBJECTIVE: With a view of exploring the absorption, distribution, metabolism, excretion and toxicity (ADMET) profile of plant-based anticancer compounds, open-access databases (NPACT, CancerHSP and TaxKB) were analysed to identify molecules having properties favourable for drug ability...
April 18, 2018: Phytochemical Analysis: PCA
https://www.readbyqxmd.com/read/29667720/mycophenolate-mofetil-administered-every-8-hours-in-combination-with-tacrolimus-is-efficacious-in-the-prophylaxis-of-acute-graft-versus-host-disease-in-childhood-adolescent-and-young-adult-allogeneic-stem-cell-transplantation-recipients
#4
Olga Militano, Mehmet F Ozkaynak, Brinda Mehta, Carmella van deVen, Carl Hamby, Mitchell S Cairo
BACKGROUND: The optimal dose and schedule of mycophenolate mofetil (MMF) in pediatric allogeneic stem cell transplant recipients remains to be determined. We previously reported safety and pharmacokinetics of MMF at 900 mg/m2 q6h dosing. This study was conducted to investigate the efficacy of tacrolimus plus q8h MMF dosing for acute graft versus host disease (GVHD) prophylaxis in a heterogeneous population of children, adolescent, young adult allogeneic stem cell transplant recipients, utilizing multiple allogeneic donor sources...
April 18, 2018: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/29667586/drug-drug-interactions-with-aprepitant-in-antiemetic-prophylaxis-for-chemotherapy
#5
R Schoffelen, A G Lankheet, C M L van Herpen, J J M van der Hoeven, I M E Desar, C Kramers
In the current guidelines to prevent hemotherapyinduced nausea and vomiting, multiple antiemetic drugs are administered simultaneously. In patients who receive highly emetogenic chemotherapy, aprepitant, an NK1-receptor antagonist, is combined with ondansetron and dexamethasone. Aprepitant can influence the pharmacokinetics of other drugs, as it is an inhibitor and inducer of CYP3A4. Some anticancer drugs and other co-medication frequently used in cancer patients are CYP3A4 or CYP29C substrates. We give an overview of the metabolism and current data on clinically relevant drug-drug interactions with aprepitant during chemotherapy...
April 2018: Netherlands Journal of Medicine
https://www.readbyqxmd.com/read/29667437/transdermal-buprenorphine-for-moderate-chronic-noncancer-pain-syndromes
#6
Joseph V Pergolizzi, Flaminia Coluzzi, Robert Taylor
Chronic noncancer pain has remained a challenging clinical problem. Opioid analgesics are effective, but they are known to be associated with opioid use disorder and potentially treatment-limiting side effects. Buprenorphine is a Schedule III synthetic opioid in the USA with a chemical structure similar to that of morphine but with a longer duration of action, greater potency, and other unique pharmacological attributes. Its role in treatment of chronic noncancer pain may be broader than currently thought. Areas covered: The pharmacokinetics, pharmacodynamics, clinical efficacy, and safety profile of transdermal buprenorphine in moderate chronic noncancer pain syndromes patients will be discussed...
April 18, 2018: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/29667370/systems-toxicology-approach-to-identifying-paracetamol-overdose
#7
Chantelle L Mason, Joseph Leedale, Sotiris Tasoulis, Ian Jarman, Daniel J Antoine, Steven D Webb
Paracetamol (acetaminophen (APAP)) is one of the most commonly used analgesics in the United Kingdom and the United States. However, exceeding the maximum recommended dose can cause serious liver injury and even death. Promising APAP toxicity biomarkers are thought to add value to those used currently and clarification of the functional relationships between these biomarkers and liver injury would aid clinical implementation of an improved APAP toxicity identification framework. The framework currently used to define an APAP overdose is highly dependent upon time since ingestion and initial dose; information that is often highly unpredictable...
April 18, 2018: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/29667134/two-phase-i-pharmacokinetic-and-pharmacodynamic-studies-of-dfp-10917-a-novel-nucleoside-analog-with-14-day-and-7-day-continuous-infusion-schedules
#8
Kamalesh Sankhala, Chris H Takimoto, Alain C Mita, Henry Xiong, Jordi Rodón, Amir Mehrvarz Sarshekeh, K Burns, Kenzo Iizuka, Scott Kopetz
Purpose DFP-10917 is a novel deoxycytidine analog with a unique mechanism of action. Brief exposure to high concentrations of DFP-10917 inhibits DNA polymerase resulting in S-phase arrest, while prolonged exposure to DFP-10917 at low concentration causes DNA fragmentation, G2/M-phase arrest, and apoptosis. DFP-10917 demonstrated activity in tumor xenografts resistant to other deoxycytidine analogs. Experimental design Two phase I studies assessed the safety, pharmacokinetic, pharmacodynamic and preliminary efficacy of DFP-10917...
April 18, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29667038/complex-drug-drug-gene-disease-interactions-involving-cytochromes-p450-systematic-review-of-published-case-reports-and-clinical-perspectives
#9
REVIEW
Flavia Storelli, Caroline Samer, Jean-Luc Reny, Jules Desmeules, Youssef Daali
Drug pharmacokinetics (PK) is influenced by multiple intrinsic and extrinsic factors, among which concomitant medications are responsible for drug-drug interactions (DDIs) that may have a clinical relevance, resulting in adverse drug reactions or reduced efficacy. The addition of intrinsic factors affecting cytochromes P450 (CYPs) activity and/or expression, such as genetic polymorphisms and diseases, may potentiate the impact and clinical relevance of DDIs. In addition, greater variability in drug levels and exposures has been observed when such intrinsic factors are present in addition to concomitant medications perpetrating DDIs...
April 17, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29666902/effect-of-cyp2c19-ugt1a8-and-ugt2b7-on-valproic-acid-clearance-in-children-with-epilepsy-a-population-pharmacokinetic-model
#10
Shenghui Mei, Weixing Feng, Leting Zhu, Xingang Li, Yazhen Yu, Weili Yang, Baoqin Gao, Xiaojuan Wu, Fang Fang, Zhigang Zhao
PURPOSE: Valproic acid (VPA) is an important drug in seizure control with great inter-individual differences in metabolism and treatment effect. This study aims to identify the effects of genetic variants on VPA clearance in a population pharmacokinetic (popPK) model in children with epilepsy. METHODS: A total of 325 VPA plasma concentrations from 290 children with epilepsy were used to develop the popPK model by using the nonlinear mixed-effects modeling method...
April 17, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29666901/subcutaneously-administered-dexmedetomidine-is-efficiently-absorbed-and-is-associated-with-attenuated-cardiovascular-effects-in-healthy-volunteers
#11
P Uusalo, D Al-Ramahi, I Tilli, R A Aantaa, M Scheinin, T I Saari
PURPOSE: Palliative care patients often need sedation to alleviate intractable anxiety, stress, and pain. Dexmedetomidine is used for sedation of intensive care patients, but there is no prior information on its subcutaneous (SC) administration, a route that would be favored in palliative care. We compared the pharmacokinetics and cardiovascular, sympatholytic, and sedative effects of SC and intravenously (IV) administered dexmedetomidine in healthy volunteers. METHODS: An open two-period, cross-over design with balanced randomization was used...
April 17, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29666562/preclinical-in-vitro-and-in-vivo-evaluation-of-18-f-fe-suppy-for-cancer-pet-imaging-limitations-of-a-xenograft-model-for-colorectal-cancer
#12
T Balber, J Singer, N Berroterán-Infante, M Dumanic, L Fetty, J Fazekas-Singer, C Vraka, L Nics, M Bergmann, K Pallitsch, H Spreitzer, W Wadsak, M Hacker, E Jensen-Jarolim, H Viernstein, M Mitterhauser
Molecular imaging probes such as PET-tracers have the potential to improve the accuracy of tumor characterization by directly visualizing the biochemical situation. Thus, molecular changes can be detected early before morphological manifestation. The A3 adenosine receptor (A3 AR) is described to be highly expressed in colon cancer cell lines and human colorectal cancer (CRC), suggesting this receptor as a tumor marker. The aim of this preclinical study was the evaluation of [18 F]FE@SUPPY as a PET-tracer for CRC using in vitro imaging and in vivo PET imaging...
2018: Contrast Media & Molecular Imaging
https://www.readbyqxmd.com/read/29666359/pharmacokinetic-and-pharmacodynamics-of-self-assembled-cubic-liquid-crystalline-nanoparticle-gel-after-transdermal-administration
#13
Na Zhu, Xiao-Xiang Wu, Yong Tian, Jin-Xiu Zhu, Jian-Chun Li
BACKGROUND The aim of this study was to assess the pharmacokinetics after transdermal administration by a novel skin microdialysis technology in rats. The guinea pig model was established by investigating the pharmacodynamics. MATERIAL AND METHODS Three different agents were given after hair removal, and the samples were extracted by microdialysis and detected by HPLC. Subcutaneous/plasma concentration-time curves of the 3 different agents were analyzed and the pharmacokinetic parameters were calculated. The SS-04B UV light therapy instrument was used in the modeling...
April 18, 2018: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
https://www.readbyqxmd.com/read/29665950/conducting-efficacy-trials-in-children-with-mdr-tb-what-is-the-rationale-and-how-should-they-be-done
#14
J A Seddon, E D Weld, H S Schaaf, A J Garcia-Prats, S Kim, A C Hesseling
Paediatric anti-tuberculosis treatment trials have traditionally been limited to Phase I/II studies evaluating the drug pharmacokinetics and safety in children, with assumptions about efficacy made by extrapolating data from adults. However, it is increasingly being recognised that, in some circumstances, efficacy trials are required in children. The current treatment for children with multidrug-resistant tuberculosis (MDR-TB) is long and toxic; shorter, safer regimens, using novel agents, require urgent evaluation...
May 1, 2018: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/29665949/current-status-of-pharmacokinetic-and-safety-studies-of-multidrug-resistant-tuberculosis-treatment-in-children
#15
A J Garcia-Prats, E M Svensson, E D Weld, H S Schaaf, A C Hesseling
After decades of neglect, data are finally becoming available on the appropriate, safe dosing of key second-line anti-tuberculosis drugs used for treating multidrug-resistant tuberculosis (MDR-TB) in children, including levofloxacin (LVX), moxifloxacin (MFX), linezolid (LZD) and delamanid (DLM). Much needed data on some novel and repurposed drugs are still lacking, including for bedaquiline (BDQ), pretomanid (PTM) and clofazimine (CFZ). We review the status of pharmacokinetic (PK) and safety studies of key anti-tuberculosis medications in children with MDR-TB, identify priority knowledge gaps and note ongoing work to address those gaps, in the context of planning for an efficacy trial in children with MDR-TB...
May 1, 2018: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/29665526/novel-hydrazide-hydrazone-and-amide-substituted-coumarin-derivatives-synthesis-cytotoxicity-screening-microarray-radiolabeling-and-in-vivo-pharmacokinetic-studies
#16
Tamer Nasr, Samir Bondock, Hassan M Rashed, Walid Fayad, Mahmoud Youns, Tamer M Sakr
The current work presents the synthesis and biological evaluation of new series of coumarin hydrazide-hydrazone derivatives that showed in vitro broad spectrum antitumor activities against resistant pancreatic carcinoma (Panc-1), hepatocellular carcinoma (HepG2) and leukemia (CCRF) cell lines using doxorubicin as reference standard. Bromocoumarin hydrazide-hydrazone derivative (BCHHD) 11b showed excellent anticancer activity against all tested cancer cell lines. Enzyme assays showed that BCHHD 11b induced apoptosis due to activation of caspases 3/7...
April 9, 2018: European Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29665413/genetic-risk-factors-for-post-transplantation-diabetes-mellitus-in-chinese-han-renal-allograft-recipients-treated-with-tacrolimus
#17
Xiaoming Zhang, Tongyi Men, Haitao Liu, Xianduo Li, Jianning Wang, Jiaju Lv
BACKGROUND: Post-transplantation diabetes mellitus (PTDM) is a serious metabolic complication after kidney transplantation. The aim of this study was to explore the association of clinical variables and five selected single nucleotide polymorphisms (SNPs) with PTDM in Chinese Han renal allograft recipients taking tacrolimus (TAC). METHODS: A total of 129 non-diabetic, primary, Chinese Han renal allograft recipients treated with TAC were enrolled. Five SNPs (CYP3A5 rs776741, rs776746, rs15524, CYP24A1 rs2296241, and PPARG rs1801282) were genotyped and analyzed...
April 14, 2018: Transplant Immunology
https://www.readbyqxmd.com/read/29665383/impact-of-aging-alzheimer-s-disease-and-parkinson-s-disease-on-the-blood-brain-barrier-transport-of-therapeutics
#18
Yijun Pan, Joseph A Nicolazzo
Older people are at greater risk of medicine-induced toxicities resulting from either increased drug sensitivity or age-related pharmacokinetic changes. The scenario is further complicated with the two most prevalent age-related neurodegenerative diseases, Alzheimer's disease (AD) and Parkinson's disease (PD). With aging, AD and PD, there is growing evidence of altered structure and function of the blood-brain barrier (BBB), including modifications to tight junctions and efflux transporters, such as P-glycoprotein...
April 14, 2018: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/29665289/a-whole-body-physiologically-based-pharmacokinetic-model-for-colistin-and-colistin-methanesulfonate-cms-in-rat
#19
Salim Bouchene, Sandrine Marchand, William Couet, Lena E Friberg, Patrice Gobin, Isabelle Lamarche, Nicolas Grégoire, Sven Björkman, Mats O Karlsson
Colistin is a polymyxin antibiotic used to treat patients infected with multidrug-resistant Gram negative bacteria (MDR-GNB). The objective of this work was to develop a whole-body physiologically based pharmacokinetic (WB-PBPK) model to predict tissue distribution of colistin in rat. The distribution of a drug in a tissue is commonly characterized by its tissue-to-plasma partition coefficient, Kp . Colistin and its prodrug, colistin methanesulfonate (CMS) Kp priors were measured experimentally from rat tissue homogenates or predicted in silico...
April 17, 2018: Basic & Clinical Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29665130/optimization-of-a-drug-transporter-probe-cocktail-potential-screening-tool-for-transporter-mediated-drug-drug-interactions
#20
Peter Stopfer, Thomas Giessmann, Kathrin Hohl, Sabine Hutzel, Sven Schmidt, Dietmar Gansser, Naoki Ishiguro, Mitchell E Taub, Ashish Sharma, Thomas Ebner, Fabian Müller
AIMS: Previous pharmacokinetic characterization of a transporter probe cocktail containing digoxin (P-gp), furosemide (OAT1, OAT3), metformin (OCT2, MATE1, MATE2-K) and rosuvastatin (OATP1B1, OATP1B3, BCRP) in healthy subjects showed increases in rosuvastatin systemic exposure compared to rosuvastatin alone. In this trial, the doses of metformin and furosemide as putative perpetrators were reduced to eliminate their drug-drug interaction (DDI) with rosuvastatin. METHODS: In a randomized, open label, single center, five-treatment, five-period crossover trial, 30 healthy male subjects received as reference treatments separately 0...
April 17, 2018: British Journal of Clinical Pharmacology
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