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Clinical pharmacokinetics

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https://www.readbyqxmd.com/read/28741923/codelivery-of-trichosanthin-and-albendazole-by-nano-self-assembly-for-overcoming-tumor-multidrug-resistance-and-metastasis
#1
Yisi Tang, Jianming Liang, Aihua Wu, Yingzhi Chen, Pengfei Zhao, Tingting Lin, Meng Zhang, Qin Xu, Jianxin Wang, Yongzhuo Huang
Multidrug resistance (MDR) and metastasis are the major obstacles in cancer chemotherapy. Nanotechnology-based combination therapy is a useful strategy. Recently, the combination of biologics and small drugs has attracted much attention in cancer therapy. Yet, the treatment outcomes are often compromised by the different pharmacokinetics profiles of the co-administered drugs, thus leading to inconsistent drug uptake and suboptimal drug combination at the tumor sites. Nanotechnology-based codelivery offers a promising method to address this problem, which is well demonstrated in the use of small drugs combination...
July 25, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28741871/pharmacodynamics-pharmacokinetics-safety-and-tolerability-of-the-novel-dual-glucose-dependent-insulinotropic-polypeptide-glucagon-like-peptide-1-agonist-rg7697-after-single-subcutaneous-administration-in-healthy-subjects
#2
Agnès Portron, Shirin Jadidi, Neena Sarkar, Richard DiMarchi, Christophe Schmitt
AIMS: To evaluate the pharmacodynamics, pharmacokinetics and safety of single subcutaneous (s.c.) injection of ascending doses of RG7697, a dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonist, in healthy subjects. METHODS: A total of 51 healthy volunteers were enrolled in this double-blind, placebo-controlled study investigating RG7697 doses ranging from 0.03 to 5 mg. Adverse events (AEs) were monitored and drug concentrations, fasting glycaemic variables, vital signs, ECG, antibody formation and routine laboratory variables were assessed...
July 25, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28741675/pharmacokinetics-of-dinalbuphine-sebacate-and-nalbuphine-in-human-after-intramuscular-injection-of-dinalbuphine-sebacate-in-an-extended-release-formulation
#3
Yu En Tien, Wen-Chuan Huang, Hui-Yuan Kuo, Lily Tai, Yow-Shieng Uang, Wendy H Chern, Jin-Ding Huang
Nalbuphine is a semi-synthetic opioid indicated for the relief of moderate to severe pain. Its short half-life requires frequent injections in clinical practices, resulting in greater incidences of adverse events. We have developed a prodrug of nalbuphine, dinalbuphine sebacate (DNS), dissolved in a simple oil-based injectable formulation, which could deliver and maintain effective blood nalbuphine level. An open-label, prospective, two-period study was performed in healthy volunteers to verify the extended blood concentration profile of nalbuphine...
July 25, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28741299/a-review-of-moxifloxacin-for-the-treatment-of-drug-susceptible-tuberculosis
#4
REVIEW
Anushka Naidoo, Kogieleum Naidoo, Helen McIlleron, Sabiha Essack, Nesri Padayatchi
Moxifloxacin, an 8-methoxy quinolone, is an important drug in the treatment of multidrug-resistant tuberculosis and is being investigated in novel drug regimens with pretomanid, bedaquiline, and pyrazinamide, or rifapentine, for the treatment of drug-susceptible tuberculosis. Early results of these studies are promising. Although current evidence does not support the use of moxifloxacin in treatment-shortening regimens for drug-susceptible tuberculosis, it may be recommended in patients unable to tolerate standard first-line drug regimens or for isoniazid monoresistance...
July 24, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28739792/transfersomal-phage-cocktail-an-effective-treatment-against-methicillin-resistant-s-aureus-mrsa-mediated-skin-and-soft-tissue-infections-sstis
#5
Sanjay Chhibber, Ashu Shukla, Sandeep Kaur
Emergence of drug resistance has rekindled the interest in phage therapy as an alternative treatment option. Its potency, safety and proven efficacy is worth noting. However, phage therapy still suffers from issues of poor stability, narrow spectrum and poor pharmacokinetic profile. It therefore becomes essential to look into the use of Drug Delivery Systems (DDS) for efficient delivery of lytic phages in vivo For the first time, the present study has evaluated the use of nano-structured lipid based carriers i...
July 24, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28738769/endogenous-biomarkers-to-assess-drug-drug-interactions-by-drug-transporters-and-enzymes
#6
T Thanga Mariappan, Hong Shen, Punit Marathe
Drug-drug interactions (DDI) by modulation of drug transporters or drug metabolizing enzymes are common in multi-drug therapy. DDI potential of any new drugs are assessed by conducting separate clinical studies using relevant probe substrates, which involves additional resource and cost. Recently, several endogenous compounds were evaluated as substrates of transporters and enzymes that could be assessed as part of early clinical trials along with the assessment of drug pharmacokinetics, pharmacodynamics and safety studies...
July 24, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28738768/current-status-of-the-pharmacokinetics-and-pharmacodynamics-of-hiv-1-entry-inhibitors-and-hiv-therapy
#7
Fengyan Xu, Edward P Acosta, Liyu Liang, Yingchun He, Juan Yang, Corenna Kerstner-Wood, Qingshang Zheng, Jihan Huang, Kun Wang
Human immunodeficiency virus (HIV) entry inhibitors target the first step of the HIV life cycle and efficiently inhibit HIV from infecting the immune cells which is a key prerequisite for viral spread. Because of their unique mechanism of action on cell-cell transmission they may provide a promising perspective for the treatment of AIDS. Maraviroc (MVC) and Enfuvirtide (ENF) have been approved by the FDA for the treatment of HIV-1 infection. Attachment inhibitors (BMS-663068 and TNX-355) and co-receptor inhibitors (PRO-140 and Cenicriviroc (CVC)) have reached phase II or III clinical trials...
July 24, 2017: Current Drug Metabolism
https://www.readbyqxmd.com/read/28738449/pbpk-modeling-of-the-effect-of-reduced-kidney-function-on-the-pharmacokinetics-of-drugs-excreted-renally-by-organic-anion-transporters
#8
C-H Hsueh, V Hsu, P Zhao, L Zhang, K M Giacomini, S-M Huang
Altered pharmacokinetics (PK) in subjects with chronic kidney disease (CKD) may lead to dosing adjustment of certain drugs in subjects with CKD. It can be valuable to quantitatively predict PK in CKD for the management of drug dosing in these subjects. We developed physiologically based pharmacokinetic (PBPK) models of seven renally eliminated drugs: adefovir, avibactam, entecavir, famotidine, ganciclovir, oseltamivir carboxylate, and sitagliptin. These drugs are all substrates of renal organic anion transporters (OATs)...
July 24, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28738003/pharmacokinetics-and-egg-residues-after-oral-administration-of-a-single-dose-of-meloxicam-in-domestic-chickens-gallus-domesticus
#9
Marcy J Souza, Joan B Bergman, Molly S White, Kristen I Gordon, Lillian E Gerhardt, Sherry K Cox
OBJECTIVE To determine the pharmacokinetics of meloxicam in domestic hens and duration and quantity of drug residues in their eggs following PO administration of a single dose (1 mg of meloxicam/kg). ANIMALS 8 healthy adult White Leghorn hens. PROCEDURES Hens were administered 1 mg of meloxicam/kg PO once. A blood sample was collected immediately before and at intervals up to 48 hours after drug administration. The hens' eggs were collected for 3 weeks after drug administration. Samples of the hens' plasma, egg whites (albumen), and egg yolks were analyzed by high-performance liquid chromatography...
August 2017: American Journal of Veterinary Research
https://www.readbyqxmd.com/read/28737428/chromatographic-determination-of-zonisamide-topiramate-and-sulpiride-in-plasma-by-a-fluorescent-turn-on-chemosensor
#10
Fawzia A Ibrahim, Amira F El-Yazbi, Mira M Wagih, Magda A Barary
AIM: Antiepileptics (AEDs) and antipsychotics are often coprescribed. Interactions between these drugs may affect both efficacy and toxicity. Therefore, drug monitoring is necessary for appropriate dosage adjustments. MATERIALS & METHODS: Specific 'turn-on' chemosensor, 4-chloro-7-nitrobenzofurazan is used for selective and sensitive determination of two AEDs: zonisamide (ZON) and topiramate (TOP) with the antipsychotic sulpiride (SUL) in epileptic patients' plasma followed by reversed-phase-HPLC separation without any interference...
July 24, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28737128/bioequivalence-of-two-oseltamivir-formulations-in-healthy-chinese-volunteers%C3%A2
#11
Yun-Lei Yun, Shou-Hong Gao, Yan Wen, Zhi-Peng Wang, Hai-Jun Miao, Wan-Sheng Chen
BACKGROUND: The aim of this study was to compare the bioavailability of a new generic formulation of oseltamivir 75-mg capsule (test) and a branded formulation Tamiflu® (reference) to meet regulatory criteria for marketing the test product in healthy Chinese male volunteers. METHODS: This single-dose, randomized-sequence, open-label, two-period crossover study was conducted in fasted healthy Chinese male volunteers, who first received a single oral dose of the test or reference formulation with a 7-day washout period, and then the alternative formulation...
July 24, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28737127/pharmacokinetics-and-safety-of-sacubitril-valsartan-lcz696-in-patients-with-mild-and-moderate-hepatic-impairment%C3%A2
#12
Kenneth M Kulmatycki, Thomas Langenickel, Wai Hong Ng, Parasar Pal, Wei Zhou, Tsu-Han Lin, Iris Rajman, Priyamvada Chandra, Gangadhar Sunkara
OBJECTIVES: To assess the protein binding and pharmacokinetics of sacubitril/valsartan analytes (sacubitril, sacubitrilat, and valsartan) in an open-label, single oral dose (200 mg), parallel-group study in patients with mild and moderate hepatic impairment (Child-Pugh class A and B) and matched healthy subjects. METHODS: This study enrolled 32 subjects (n = 8 in each hepatic impairment and matched healthy subjects groups). Blood samples were collected at pre-determined time points to assess pharmacokinetics of sacubitril, sacubitrilat, and valsartan...
July 24, 2017: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28736918/phase-1-randomized-double-blind-placebo-controlled-single-dose-and-multiple-dose-studies-of-erenumab-in-healthy-subjects-and-patients-with-migraine
#13
Jan de Hoon, Anne Van Hecken, Corinne Vandermeulen, Lucy Yan, Brian Smith, Jiyun Sunny Chen, Edgar Bautista, Lisa Hamilton, Javier Waksman, Thuy Vu, Gabriel Vargas
Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) signaling are being explored as prophylactic treatments for migraine. Erenumab (AMG 334) is the first potent, selective, and competitive human mAb antagonist of the CGRP receptor. We report the data from two phase 1 studies assessing the safety, pharmacokinetics (PK), and pharmacodynamics of single and multiple administrations of erenumab in healthy subjects and patients with migraine. The results indicate that the PK profile of erenumab is nonlinear from 1 mg to 70 mg and the linear portion of the clearance from 70 mg to 210 mg is consistent with other human immunoglobulin (Ig)G2 antibodies...
July 24, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28735378/a-phase-i-ii-trial-and-pharmacokinetic-study-of-mithramycin-in-children-and-adults-with-refractory-ewing-sarcoma-and-ews-fli1-fusion-transcript
#14
Patrick J Grohar, John Glod, Cody J Peer, Tristan M Sissung, Fernanda I Arnaldez, Lauren Long, William D Figg, Patricia Whitcomb, Lee J Helman, Brigitte C Widemann
PURPOSE: In a preclinical drug screen, mithramycin was identified as a potent inhibitor of the Ewing sarcoma EWS-FLI1 transcription factor. We conducted a phase I/II trial to determine the dose-limiting toxicities (DLT), maximum tolerated dose (MTD), and pharmacokinetics (PK) of mithramycin in children with refractory solid tumors, and the activity in children and adults with refractory Ewing sarcoma. PATIENTS AND METHODS: Mithramycin was administered intravenously over 6 h once daily for 7 days for 28 day cycles...
July 22, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28735000/application-of-pharmacometrics-and-quantitative-systems-pharmacology-to-cancer-therapy-the-example-of-luminal-a-breast-cancer
#15
REVIEW
Brett Fleisher, Kayla Andrews, Ashley A Brown, Sihem Ait-Oudhia
Breast cancer (BC) is the most common cancer in women, and the second most frequent cause of cancer-related deaths in women worldwide. It is a heterogeneous disease composed of multiple subtypes with distinct morphologies and clinical implications. Quantitative systems pharmacology (QSP) is an emerging discipline bridging systems biology with pharmacokinetics (PK) and pharmacodynamics (PD) leveraging the systematic understanding of drugs' efficacy and toxicity. Despite numerous challenges in applying computational methodologies for QSP and mechanism-based PK/PD models to biological, physiological, and pharmacological data, bridging these disciplines has the potential to enhance our understanding of complex disease systems such as BC...
July 19, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28734960/pharmacokinetic-interactions-of-curcuminoids-with-conventional-drugs-a-review
#16
REVIEW
Roodabeh Bahramsoltani, Roja Rahimi, Mohammad Hosein Farzaei
ETHNOPHARMACOLOGICAL RELEVANCE: Herb-drug interactions are of great concern in health practices. Curcumin is a natural polyphenol extracted from turmeric, a spice widely used all over the world. Curcumin is clinically used due to its acceptable safety profile and therapeutic efficacy. AIM OF THE STUDY: Current paper aims to highlight the effect of curcumin on concomitantly used drugs. METHODS: Electronic databases including PubMed, Scopus and Science Direct were searched with the keywords "curcumin" in the title/abstract and "drug interaction," "drug metabolism," "cytochrome," "P-glycoprotein" and "P450" in the whole text...
July 19, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/28734199/endosulfan-poisoning-an-overview
#17
REVIEW
Ritesh G Menezes, Tooba Fatima Qadir, Ariba Moin, Huda Fatima, Syed Ather Hussain, Mohammed Madadin, Syed Bilal Pasha, Fatima A Al Rubaish, S Senthilkumaran
Endosulfan, an organochlorine (OC) insecticide, is a widely used agricultural pesticide, despite its life threatening toxic effects. In this review, the pharmacokinetics of endosulfan, mechanism of endosulfan toxicity, clinical presentations and management, histopathological findings, and toxicological analysis are described, in addition to its environmental toxicity. The toxic effects of endosulfan can affect many organs and systems presenting in a wide array of signs and symptoms. Although termed a restricted OC-classed pesticide, it continues to be used, especially in the developing world, owing to its beneficial effects on agriculture...
July 5, 2017: Journal of Forensic and Legal Medicine
https://www.readbyqxmd.com/read/28733862/recommendations-for-systematic-statistical-computation-of-immunogenicity-cut-points
#18
Viswanath Devanarayan, Wendell C Smith, Rocco L Brunelle, Mary E Seger, Kim Krug, Ronald R Bowsher
Today, the assessment of immunogenicity is integral in nonclinical and clinical testing of new biotherapeutics and biosimilars. A key component in the risk-based evaluation of immunogenicity involves the detection and characterization of anti-drug antibodies (ADA). Over the past couple of decades, much progress has been made in standardizing the generalized approach for ADA testing with a three-tiered testing paradigm involving screening, confirmation, and quasi-quantitative titer assessment representing the typical harmonized scheme...
July 21, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28732567/curcumin-3-4-dichloro-phenyl-pyrazole-cdpp-overcomes-curcumin-s-low-bioavailability-inhibits-adipogenesis-and-ameliorates-dyslipidemia-by-activating-reverse-cholesterol-transport
#19
Abhishek Gupta, Vinay Kumar Singh, Durgesh Kumar, Pragya Yadav, Santosh Kumar, Muheeb Beg, Kripa Shankar, Salil Varshney, Sujith Rajan, Ankita Srivastava, Rakhi Choudhary, Vishal M Balaramnavar, Rabi Bhatta, Narender Tadigoppula, Anil Nilkanth Gaikwad
BACKGROUND: Adipocyte dysfunction, obesity and associated metabolic disorders are of prime healthcare concern worldwide. Among available medications, natural products and inspired molecules hold 40% space in clinically prescribed medicines. In queue, this study overcomes the drawback of curcumin's low bioavailability with potent anti-adipogenic and anti-dyslipidemic activity. METHODS: To evaluate the role of CDPP on adipocyte differentiation, 3T3-L1 adipocytes were used as an in-vitro model...
August 2017: Metabolism: Clinical and Experimental
https://www.readbyqxmd.com/read/28730896/cannabinoid-hyperemesis-syndrome-potential-mechanisms-for-the-benefit-of-capsaicin-and-hot-water-hydrotherapy-in-treatment
#20
John R Richards, Jeff M Lapoint, Guillermo Burillo-Putze
INTRODUCTION: Cannabinoid hyperemesis syndrome is a clinical disorder that has become more prevalent with increasing use of cannabis and synthetic cannabinoids, and which is difficult to treat. Standard antiemetics commonly fail to alleviate the severe nausea and vomiting characteristic of the syndrome. Curiously, cannabinoid hyperemesis syndrome patients often report dramatic relief of symptoms with hot showers and baths, and topical capsaicin. OBJECTIVES: In this review, we detail the pharmacokinetics and pharmacodynamics of capsaicin and explore possible mechanisms for its beneficial effect, including activation of transient receptor potential vanilloid 1 and neurohumoral regulation...
July 21, 2017: Clinical Toxicology
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