journal
MENU ▼
Read by QxMD icon Read
search

Clinical Pharmacokinetics

journal
https://www.readbyqxmd.com/read/28066880/population-pharmacokinetic-analysis-of-daclatasvir-in-subjects-with-chronic-hepatitis-c-virus-infection
#1
Phyllis Chan, Hanbin Li, Li Zhu, Marc Bifano, Timothy Eley, Mayu Osawa, Takayo Ueno, Eric Hughes, Richard Bertz, Tushar Garimella, Malaz AbuTarif
BACKGROUND AND OBJECTIVE: Daclatasvir is a potent, pangenotypic once-daily hepatitis C virus (HCV) NS5A inhibitor that is approved for the treatment of chronic HCV infection. The objective of this analysis was to characterize the pharmacokinetics of daclatasvir in subjects with chronic HCV infection. METHODS: A population pharmacokinetic (PPK) model was developed to evaluate effects of covariates on daclatasvir pharmacokinetics in subjects with chronic HCV infection (n = 2149 from 11 studies)...
January 9, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28066879/population-pharmacokinetics-and-immunogenicity-of-adalimumab-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa
#2
Ahmed Nader, Denise Beck, Peter Noertersheuser, David Williams, Nael Mostafa
INTRODUCTION: Hidradenitis suppurativa (HS) is a serious, debilitating, chronic inflammatory skin disease. Adalimumab is a fully human, immunoglobulin G1 monoclonal antibody specific for tumor necrosis factor-alpha recently approved for use in patients with HS. The aim of this study is to describe the population pharmacokinetics and immunogenicity of adalimumab in adult patients with HS. METHODS: Data from one phase II and two phase III studies were included in the analysis...
January 9, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28063031/pharmacokinetics-and-pharmacodynamics-of-afamelanotide-and-its-clinical-use-in-treating-dermatologic-disorders
#3
REVIEW
Elisabeth I Minder, Jasmin Barman-Aksoezen, Xiaoye Schneider-Yin
Afamelanotide, the first α-melanocyte-stimulating hormone (MSH) analogue, synthesized in 1980, was broadly investigated in all aspects of pigmentation because its activity and stability were higher than the natural hormone. Afamelanotide binds to the melanocortin-1 receptor (MC1R), and MC1R signaling increases melanin synthesis, induces antioxidant activities, enhances DNA repair processes and modulates inflammation. The loss-of-function variants of the MC1R present in fair-skinned Caucasians are less effectively activated by the natural hormone...
January 6, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28063030/target-mediated-drug-disposition-population-pharmacokinetics-model-of-alirocumab-in-healthy-volunteers-and-patients-pooled-analysis-of-randomized-phase-i-ii-iii-studies
#4
Nassim Djebli, Jean-Marie Martinez, Laura Lohan, Sonia Khier, Aurélie Brunet, Fabrice Hurbin, David Fabre
BACKGROUND AND OBJECTIVE: Proprotein convertase subtilisin/kexin type 9 inhibition with monoclonal antibodies such as alirocumab significantly reduces low-density lipoprotein-cholesterol levels ± other lipid-lowering therapies. We aimed to develop and qualify a population pharmacokinetics (PopPK) model for alirocumab in healthy subjects and patients, taking into account the mechanistic target-mediated drug disposition (TMDD) process. METHODS: This TMDD model was developed using a subset of the alirocumab clinical trial database, including nine phase I/II/III studies (n = 527); the model was subsequently expanded to a larger data set of 13 studies (n = 2870)...
January 6, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28050889/clinical-pharmacokinetics-and-pharmacodynamics-of-albiglutide
#5
REVIEW
Andreas Brønden, Filip K Knop, Mikkel B Christensen
Albiglutide is a long-acting, glucagon-like peptide-1 receptor agonist for subcutaneous administration with a recommended dose of 30-50 mg once weekly. The aim of this article is to outline the pharmacokinetic and pharmacodynamic properties of albiglutide including the clinical efficacy and safety data underlying the approval of albiglutide for the treatment of type 2 diabetes mellitus in both Europe and USA. Albiglutide is cleared from the circulation (by a mechanism partially dependent on renal function) with an elimination half-life of 5 days, allowing once-weekly administration...
January 3, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28050888/a-new-cyp3a5-3-and-cyp3a4-22-cluster-influencing-tacrolimus-target-concentrations-a-population-approach
#6
Franc Andreu, Helena Colom, Laure Elens, Teun van Gelder, Ronald H N van Schaik, Dennis A Hesselink, Oriol Bestard, Joan Torras, Josep M Cruzado, Josep M Grinyó, Nuria Lloberas
BACKGROUND: Single nucleotide polymorphisms (SNPs) in the CYP3A5 and CYP3A4 genes have been reported to be an important cause of variability in the pharmacokinetics of tacrolimus in renal transplant patients. The aim of this study was to merge all of the new genetic information available with tacrolimus pharmacokinetics to generate a more robust population model with data from renal transplant recipients. METHODS: Tacrolimus exposure data from 304 renal transplant recipients were collected throughout the first year after transplantation and were simultaneously analyzed with a population pharmacokinetic approach using NONMEM(®) version 7...
January 3, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28039606/development-of-a-physiologically-based-pharmacokinetic-modelling-approach-to-predict-the-pharmacokinetics-of-vancomycin-in-critically-ill-septic-patients
#7
Christian Radke, Dagmar Horn, Christian Lanckohr, Björn Ellger, Michaela Meyer, Thomas Eissing, Georg Hempel
BACKGROUND AND OBJECTIVES: Sepsis is characterised by an excessive release of inflammatory mediators substantially affecting body composition and physiology, which can be further affected by intensive care management. Consequently, drug pharmacokinetics can be substantially altered. This study aimed to extend a whole-body physiologically based pharmacokinetic (PBPK) model for healthy adults based on disease-related physiological changes of critically ill septic patients and to evaluate the accuracy of this PBPK model using vancomycin as a clinically relevant drug...
December 31, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28039605/pharmacokinetic-characteristics-and-clinical-efficacy-of-an-sglt2-inhibitor-plus-dpp-4-inhibitor-combination-therapy-in-type-2-diabetes
#8
REVIEW
André J Scheen
Type 2 diabetes (T2D) generally requires a combination of several pharmacological approaches to control hyperglycaemia. Combining a sodium-glucose cotransporter type 2 inhibitor (SGLT2I, also known as gliflozin) and a dipeptidyl peptidase-4 inhibitor (DPP-4I, also known as gliptin) appears to be an attractive strategy because of complementary modes of action. This narrative review analyzes the pharmacokinetics and clinical efficacy of different combined therapies with an SGLT2I (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, tofogliflozin) and DPP-4I (linagliptin, saxagliptin, sitagliptin, teneligliptin)...
December 30, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28035590/author-s-reply-to-proost-challenges-in-individualizing-drug-dosage-for-intensive-care-unit-patients
#9
LETTER
Roger W Jelliffe
No abstract text is available yet for this article.
December 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28035589/caspofungin-population-pharmacokinetics-in-critically-ill-patients-undergoing-continuous-veno-venous-haemofiltration-or-haemodiafiltration
#10
Claire Roger, Steven C Wallis, Laurent Muller, Gilbert Saissi, Jeffrey Lipman, Roger J Brüggemann, Jean-Yves Lefrant, Jason A Roberts
BACKGROUND AND OBJECTIVE: Sepsis and continuous renal replacement therapy (CRRT) can both significantly affect antifungal pharmacokinetics. This study aimed to describe the pharmacokinetics of caspofungin in critically ill patients during different CRRT modes. METHODS: Patients receiving caspofungin and undergoing continuous veno-venous haemofiltration (CVVH) or haemodiafiltration (CVVHDF) were eligible to take part in the study. Blood samples were collected at seven sampling times during a dosing interval...
December 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28035588/clinical-pharmacokinetics-and-pharmacodynamics-of-naloxegol-a-peripherally-acting-%C3%A2%C2%B5-opioid-receptor-antagonist
#11
REVIEW
Khanh Bui, Diansong Zhou, Hongmei Xu, Eike Floettmann, Nidal Al-Huniti
Naloxegol is a peripherally acting µ-opioid receptor antagonist approved for use as an orally administered tablet (therapeutic doses of 12.5 and 25 mg) for the treatment of opioid-induced constipation. Over a wide dose range (i.e. single supratherapeutic doses up to 1000 mg in healthy volunteers), the pharmacokinetic properties of naloxegol appear to be time- and dose-independent. Naloxegol is rapidly absorbed, with mean time to maximum plasma concentration of <2 h. Following once-daily administration, steady state is achieved within 2-3 days and minimal accumulation is observed...
December 29, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28028767/authors-reply-to-kamel-et-al-effect-of-age-and-renal-function-on-idarucizumab-pharmacokinetics-and-idarucizumab-mediated-reversal-of-dabigatran-anticoagulant-activity-in-a-randomized-double-blind-crossover-phase-ib-study
#12
LETTER
Stephan Glund, Paul Reilly, Joanne van Ryn, Joachim Stangier
No abstract text is available yet for this article.
December 27, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28005225/improved-pharmacokinetics-with-bay-81-8973-versus-antihemophilic-factor-recombinant-plasma-albumin-free-method-a-randomized-pharmacokinetic-study-in-patients-with-severe-hemophilia-a
#13
Anita Shah, Alexander Solms, Dirk Garmann, Yvonne Katterle, Verzhiniya Avramova, Stanislav Simeonov, Toshko Lissitchkov
BACKGROUND: BAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A. OBJECTIVE: The aim of this study was to compare the pharmacokinetic (PK) profile of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) PATIENTS/METHODS: In this phase I, open-label, crossover study, men aged 18-65 years with severe hemophilia A and ≥150 exposure days to FVIII were randomized to receive a single intravenous infusion of 50 IU/kg BAY 81-8973 or rAHF-PFM, followed by crossover to a single infusion of the other treatment...
December 22, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28035591/comment-on-effect-of-age-and-renal-function-on-idarucizumab-pharmacokinetics-and-idarucizumab-mediated-reversal-of-dabigatran-anticoagulant-activity-in-a-randomized-double-blind-crossover-phase-ib-study
#14
LETTER
Kirollos S Kamel, Paul K L Chin, Matthew P Doogue, Murray L Barclay
No abstract text is available yet for this article.
December 20, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28000102/translational-modeling-and-simulation-in-supporting-early-phase-clinical-development-of-new-drug-a-learn-research-confirm-process
#15
Dongyang Liu, Yi Zhang, Ji Jiang, John Choi, Xuening Li, Dalong Zhu, Dawei Xiao, Yanhua Ding, Hongwei Fan, Li Chen, Pei Hu
BACKGROUND AND OBJECTIVE: Pharmacokinetic/pharmacodynamic modeling and simulation can aid clinical drug development by dynamically integrating key system- and drug-specific information into predictive profiles. In this study, we propose a methodology to predict pharmacokinetic/pharmacodynamic profiles of sinogliatin (HMS-5552, RO-5305552), a novel glucokinase activator to treat diabetes mellitus, for first-in-patient (FIP) studies. METHODS AND RESULTS: Initially, pharmacokinetic/pharmacodynamic profiles of sinogliatin and another glucokinase activator (US2) previously acquired from healthy subjects were fitted using Model A incorporating an indirect response mechanism...
December 20, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28000101/remarkable-pharmacokinetics-of-monoclonal-antibodies-a-quest-for-an-explanation
#16
Joannes A A Reijers, Matthijs Moerland, Jacobus Burggraaf
Monoclonal antibodies (MAbs) usually display slow and limited distribution with combined linear and non-linear elimination mechanisms. While studying individual pharmacokinetic profiles, it was noticed that MAb plasma concentration can vary abruptly over time, with one or more increases after the time to maximum plasma concentration when theoretically the concentration should only decline. This article summarizes the frequency of these additional peaks and assesses whether normal intra-subject and assay variability can explain the observations...
December 20, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27995530/a-phase-i-pharmacokinetic-study-of-trastuzumab-emtansine-t-dm1-in-patients-with-human-epidermal-growth-factor-receptor-2-positive-metastatic-breast-cancer-and-normal-or-reduced-hepatic-function
#17
Chunze Li, Priya Agarwal, Ekaterina Gibiansky, Jin Yan Jin, Susan Dent, Anthony Gonçalves, Ihsan Nijem, Alexander Strasak, Marie-Laurence Harle-Yge, Nataliya Chernyukhin, Pat LoRusso, Sandhya Girish
OBJECTIVE: The aim of this study was to evaluate the pharmacokinetics (PK) of trastuzumab emtansine (T-DM1) and relevant analytes in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer and hepatic impairment. METHODS: Patients were enrolled in three independent parallel cohorts based on hepatic function per Child-Pugh criteria: normal hepatic function, mild hepatic impairment, and moderate hepatic impairment. Patients received T-DM1 3...
December 19, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27995529/cyp2c8-genotype-significantly-alters-imatinib-metabolism-in-chronic-myeloid-leukaemia-patients
#18
Daniel T Barratt, Hannah K Cox, Andrew Menelaou, David T Yeung, Deborah L White, Timothy P Hughes, Andrew A Somogyi
OBJECTIVE: The aims of this study were to determine the effects of the CYP2C8*3 and *4 polymorphisms on imatinib metabolism and plasma imatinib concentrations in chronic myeloid leukaemia (CML) patients. METHODS: We genotyped 210 CML patients from the TIDELII trial receiving imatinib 400-800 mg/day for CYP2C8*3 (rs11572080, rs10509681) and *4 (rs1058930). Steady-state trough total plasma N-desmethyl imatinib (major metabolite):imatinib concentration ratios (metabolic ratios) and trough total plasma imatinib concentrations were compared between genotypes (one-way ANOVA with Tukey post hoc)...
December 19, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27995528/population-pharmacokinetic-approach-applied-to-positron-emission-tomography-computed-tomography-for-tumor-tissue-identification-in-patients-with-glioma
#19
Peggy Gandia, Cyril Jaudet, Hendrik Everaert, Johannes Heemskerk, Anne Marie Vanbinst, Johan de Mey, Johnny Duerinck, Bart Neyns, Mark de Ridder, Etienne Chatelut, Didier Concordet
BACKGROUND AND AIMS: 18F-fluoro-ethyl-tyrosine (FET) is a radiopharmaceutical used in positron emission tomography (PET)-computed tomography in patients with glioma. We propose an original approach combining a radiotracer-pharmacokinetic exploration performed at the voxel level (three-dimensional pixel) and voxel classification to identify tumor tissue. Our methodology was validated using the standard FET-PET approach and magnetic resonance imaging (MRI) data acquired according to the current clinical practices...
December 19, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27981509/comment-on-challenges-in-individualizing-drug-dosage-for-intensive-care-unit-patients-is-augmented-renal-clearance-what-we-really-want-to-know-some-suggested-management-approaches-and-clinical-software-tools
#20
LETTER
journal
journal
26723
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"