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Expert Opinion on Drug Metabolism & Toxicology

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https://www.readbyqxmd.com/read/28637373/efficacy-pharmacokinetic-and-pharmacodynamic-evaluation-of-apaziquone-in-the-treatment-of-non-muscle-invasive-bladder-cancer
#1
R M Phillips, H R Hendriks, J B Sweeney, G Reddy, G J Peters
Apaziquone (also known as EO9 and Qapzola) is a prodrug that is activated to DNA damaging species by oxidoreductases (particularly NQO1) and has the ability to kill aerobic and/or hypoxic cancer cells. Areas covered: Whilst its poor pharmacokinetic properties contributed to its failure in phase II clinical trials when administered intravenously, these properties were ideal for loco-regional therapies. Apaziquone demonstrated good anti-cancer activity against non-muscle invasive bladder cancer (NMIBC) when administered intravesically to marker lesions and was well tolerated with no systemic side effects...
June 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28636828/pharmacokinetic-drug-evaluation-of-extended-release-lorcaserin-for-the-treatment-of-obesity
#2
Kathryn Hurren, Marissa W Dunham
Lorcaserin is a serotonin 2C receptor antagonist that was FDA approved in 2012. Lorcaserin is recently available as an extended-release (ER) formulation for the treatment of obesity as an adjunct to lifestyle modification. Areas covered: The pharmacokinetics, pharmacodynamics, efficacy, and safety of lorcaserin ER will be reviewed. Expert opinion: Lorcaserin ER 20mg daily provides drug exposure bioequivalent to lorcaserin immediate release (IR) 10mg twice daily. Lorcaserin IR is associated with 3.3% and 3.0% placebo-subtracted weight loss in patients without and with diabetes, respectively...
June 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28612627/pharmacokinetic-drug-evaluation-of-budesonide-in-the-treatment-of-crohn-s-disease
#3
Lukasz Kwapisz, Vipul Jairath, Reena Khanna, Brian Feagan
Crohn's disease (CD) is a chronic inflammatory disorder that commonly affects the terminal ileum and proximal colon. Although systemic corticosteroids such as prednisone and methylprednisolone are widely used for treatment of CD, these agents have a high incidence of adverse drug reactions due to off-target effects. Budesonide is a locally acting corticosteroid with enhanced formulation properties that offer a superior therapeutic index in comparison to conventional members of the class. Areas covered: This review focuses on budesonide for the treatment of CD...
June 16, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28571507/the-genetic-basis-of-antiplatelet-and-anticoagulant-therapy-a-pharmacogenetic-review-of-newer-antiplatelets-clopidogrel-prasugrel-and-ticagrelor-and-anticoagulants-dabigatran-rivaroxaban-apixaban-and-edoxaban
#4
Cormac T O'connor, Thomas J Kiernan, Bryan P Yan
The study of pharmacogenomics presents the possibility of individualised optimisation of drug therapy tailored to each patients' unique physiological traits. Both antiplatelet and anticoagulant drugs play a key role in the management of cardiovascular disease. Despite their importance, there is a substantial volume of literature to suggest marked person-to-person variability in their effect. Areas covered: This article reviews the data available for the genetic cause for this inter-patient variability of antiplatelet and anticoagulant drugs...
June 13, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28604124/test-systems-in-drug-discovery-for-hazard-identification-and-risk-assessment-of-human-drug-induced-liver-injury
#5
Richard J Weaver, Catherine Betts, Eric A G Blomme, Helga H J Gerets, Klaus Gjervig Jensen, Philip G Hewitt, Satu Juhila, Gilles Labbe, Michael J Liguori, Natalie Mesens, Monday O Ogese, Mikael Persson, Jan Snoeys, James L Stevens, Tracy Walker, B Kevin Park
Introduction The liver is an important target for drug-induced toxicities. Early detection of hepatotoxic drugs requires use of well-characterized test systems, yet current knowledge, gaps and limitations of tests employed remains an important issue for drug development. Areas Covered The current state of the science, understanding and application of test systems in use for the detection of drug-induced cytotoxicity, mitochondrial toxicity, cholestasis and inflammation is summarized. The test systems highlighted herein cover mostly in vitro and some in vivo models and endpoint measurements used in the assessment of small molecule toxic liabilities...
June 12, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28571477/cardiotoxicity-of-erbb2-targeted-therapies-and-its-impact-on-drug-development-a-spotlight-on-trastuzumab
#6
Milos Dokmanovic, Kathryn E King, Nishant Mohan, Yukinori Endo, Wen Jin Wu
Trastuzumab, a therapeutic monoclonal antibody directed against ErbB2, is often noted as a successful example of targeted therapy. Trastuzumab improved outcomes for many patients with ErbB2-positive breast and gastric cancers, however, cardiac side effects [e.g., left ventricular dysfunction and congestive heart failure (CHF)] were reported in the early phase clinical studies. This finding, subsequently corroborated by multiple clinical studies, raised concerns that the observed cardiotoxicity induced by trastuzumab might adversely impact the clinical development of other therapeutics targeting ErbB family members...
June 9, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28490206/pharmacokinetics-pharmacodynamics-and-pharmacogenetics-associated-with-nonsteroidal-anti-inflammatory-drugs-and-opioids-in-pediatric-cancer-patients
#7
Jonathan E Constance, Sarah C Campbell, Amit A Somani, Venkata Yellepeddi, Katie H Owens, Catherine M T Sherwin
Advancing appropriate and adequate analgesic pharmacotherapy in pediatric patients with cancer is an area of clinical need. Few studies have been performed to evaluate the selection of an analgesic and appropriate dosing corresponding to analgesic effect among pediatric cancer patients. This review describes information related to pharmacokinetic, pharmacodynamic, and pharmacogenomic (when applicable) considerations for analgesics that are commonly used to manage pain experienced by pediatric patients with cancer...
June 5, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28511565/the-role-of-membrane-transporters-in-ovarian-cancer-chemoresistance-and-prognosis
#8
Ela Cerovska, Katerina Elsnerova, Radka Vaclavikova, Pavel Soucek
Ovarian cancer has the highest mortality rate of all cancers in women. There is currently no effective method for early diagnosis, limiting the precision of clinical expectations. Predictions of therapeutic efficacy are currently not available either. Specifically, the development of chemoresistance against conventional chemotherapy poses a fundamental complication. Some membrane transporters have been reported to influence chemoresistance, which is often associated with a poor prognosis. Areas covered: The aim of this article is to review the existing information about membrane transporters and their role in both ovarian cancer chemoresistance and its outcomes...
May 29, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28486001/predicting-and-preventing-antimicrobial-resistance-utilizing-pharmacodynamics-part-ii-gram-negative-bacteria
#9
Kamilia Abdelraouf, Kristin E Linder, Michael D Nailor, David P Nicolau
Antimicrobial resistance is a serious health threat worldwide. Better understanding of exposure targets that could suppress resistance amplification is necessary to guide the dosing of currently available agents as well as new therapies in the drug development process. Areas covered: This review will discuss studies that focused on predicting development of resistance using the pharmacokinetic-pharmacodynamic approach and how to design dosing regimens that can successfully suppress resistance emergence in Gram-negative bacteria...
May 19, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28375027/characterisation-of-data-resources-for-in-silico-modelling-benchmark-datasets-for-adme-properties
#10
K R Przybylak, J C Madden, E Covey-Crump, L Gibson, C Barber, M Patel, M T D Cronin
The cost of in vivo and in vitro screening of ADME properties of compounds has motivated efforts to develop a range of in silico models. At the heart of the development of any computational model are the data; high quality data are essential for developing robust and accurate models. The characteristics of a dataset, such as its availability, size, format and type of chemical identifiers used, influence the modelability of the data. Areas covered: This review explores the usefulness of publicly available ADME datasets for researchers to use in the development of predictive models...
April 23, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28537216/regulation-of-drug-metabolizing-enzymes-in-infectious-and-inflammatory-disease-implications-for-biologics-small-molecule-drug-interactions
#11
REVIEW
Pankajini Mallick, Guncha Taneja, Bhagavatula Moorthy, Romi Ghose
Drug-metabolizing enzymes (DMEs) are primarily down-regulated during infectious and inflammatory diseases, leading to disruption in the metabolism of small molecule drugs (smds), which are increasingly being prescribed therapeutically in combination with biologics for a number of chronic diseases. The biologics may exert pro- or anti-inflammatory effect, which may in turn affect the expression/activity of DMEs. Thus, patients with infectious/inflammatory diseases undergoing biologic/smd treatment can have complex changes in DMEs due to combined effects of the disease and treatment...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28537215/pharmacokinetic-pharmacodynamic-considerations-for-cancer-patients-undergoing-hemodialysis
#12
REVIEW
Nicolas Janus, Vincent Launay-Vacher
The increased incidence of cancer in hemodialysis patients has been discussed since the mid-70s. Today, physicians regularly encounter situations where they must manage the prescription of anticancer drugs in hemodialysis patients. Areas covered: Hemodialysis patients are at risk of dose-related toxicities due to pharmacokinetic modifications. Hemodialysis patients are at risk of therapeutic drug removal during their hemodialysis session, which may result in a loss of efficacy. In the advent of novel immunotherapies, particularly tumor vaccines, there is an increased theoretical risk of pharmacodynamic modification...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28537214/pharmacokinetic-drug-evaluation-of-safinamide-mesylate-for-the-treatment-of-mid-to-late-stage-parkinson-s-disease
#13
REVIEW
Thomas Müller
Patients with Parkinson's disease suffer from a heterogeneous expression of neurotransmitter deficits. They cause an individual variable expression of motor and non-motor symptoms. Thus, drugs with various mechanisms of actions are suitable to counteract these disease related neurotransmitter alterations. Areas covered: This invited review suggests safinamide as an ideal compound for therapy of Parkinson's disease, as its pharmacological profile includes reversible monoamine oxidase B inhibition, blockage of voltage-dependent sodium channels, modulation of calcium channels and abnormal glutamate release...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28537213/clinical-dynamics-of-dienogest-for-the-treatment-of-endometriosis-from-bench-to-bedside
#14
Antonio Simone Laganà, Salvatore Giovanni Vitale, Roberta Granese, Vittorio Palmara, Helena Ban Frangež, Eda Vrtačnik-Bokal, Benito Chiofalo, Onofrio Triolo
No abstract text is available yet for this article.
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28460576/pharmacokinetic-and-pharmacodynamic-alterations-in-older-people-with-dementia
#15
REVIEW
Emily Reeve, Shanna C Trenaman, Kenneth Rockwood, Sarah N Hilmer
The number of people with dementia internationally is increasing. Older adults with dementia are prescribed multiple medications, both to treat dementia symptoms and to manage their other medical conditions. Dementia is correlated with increasing age and frailty; this provides insight into how the efficacy and toxicity of medications may be altered in people with dementia. Areas covered: This review discusses the current evidence of the alterations in pharmacokinetics that can occur with aging, frailty and in people with dementia...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28460549/pharmacokinetic-drug-evaluation-of-brodalumab-for-the-treatment-of-psoriasis
#16
REVIEW
M Galluzzo, M Talamonti, S D'adamio, L Bianchi
Psoriasis is now understood to also be under the driving influence of the IL-17/IL-23 axis, and the medical breakthrough of novel IL-17 inhibitor medications signals a paradigm shift in the way psoriatic patients are managed medically. Brodalumab, a fully human Chinese hamster ovary cell-derived immunoglobulin G2 (IgG2) anti-IL-17RA monoclonal antibody, is currently the most-developed treatment that binds to the IL-17RA. The authors review and provide updates of efficacy and safety by several studies on brodalumab...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28425772/prediction-of-successful-dose-reduction-or-discontinuation-of-adalimumab-etanercept-or-infliximab-in-rheumatoid-arthritis-patients-using-serum-drug-levels-and-antidrug-antibody-measurement
#17
RANDOMIZED CONTROLLED TRIAL
Cam Bouman, N van Herwaarden, Fhj van den Hoogen, A van der Maas, Bjf van den Bemt, A A den Broeder
BACKGROUND: To evaluate if TNF inhibitor serum drug levels (DL) or anti-drug antibodies (ADAb) can predict successful dose reduction (in patients with high DL) or discontinuation (in patients with no/low DL or ADAb) in rheumatoid arthritis (RA) patients. RESEARCH DESIGN AND METHODS: RA patients that were using adalimumab (n = 42), etanercept (n = 76) or infliximab (n = 51) and were doing well, were tapered until discontinuation or flare (1-1.5 year follow up)...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28359183/changes-in-drug-transport-and-metabolism-and-their-clinical-implications-in-non-alcoholic-fatty-liver-disease
#18
REVIEW
Christoph G Dietrich, Monika Rau, Daniel Jahn, Andreas Geier
The incidence of non-alcoholic fatty liver disease (NAFLD) is rising, especially in Western countries. Drug treatment in patients with NAFLD is common since it is linked to other conditions like diabetes, obesity, and cardiovascular disease. Consequently, changes in drug metabolism may have serious clinical implications. Areas covered: A literature search for studies in animal models or patients with obesity, fatty liver, non-alcoholic steatohepatitis (NASH) or NASH cirrhosis published before November 2016 was performed...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28343423/management-of-precipitated-opiate-withdrawal-syndrome-induced-by-nalmefene-mistakenly-prescribed-in-opiate-dependent-patients-a-review-for-clinicians
#19
REVIEW
Nicolas Franchitto, Benedicte Jullian, Juliette Salles, Fanny Pelissier, Benjamin Rolland
Nalmefene, a long-acting µ-opioid antagonist approved to treat alcohol use disorder, is occasionally mistakenly prescribed to opiate-dependent or opioid-treated patients. We review recent literature on drug-drug interactions between nalmefene and opioids that lead to precipitated opioid withdrawal, and focus on its management and planning for care at discharge. Areas covered: This article provides a brief and comprehensive review of management of precipitated opioid withdrawal syndrome when nalmefene is associated with an opioid, whether misused or legally prescribed...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28335648/inflammation-and-pharmacokinetics-potential-implications-for-hiv-infection
#20
REVIEW
Sharon M Seifert, Jose R Castillo-Mancilla, Kristine M Erlandson, Peter L Anderson
The physiological changes accompanying inflammation may alter the pharmacokinetics (PK) of certain medications. Individuals infected with HIV have chronically elevated inflammatory markers despite viral suppression following effective antiretroviral therapy (ART), as well as age-related inflammation. Understanding the potential clinical implications of inflammation on the PK of medications is important for understanding dose-response relationships and necessitates future research. Areas covered: An extensive literature search was carried out using PubMed and associated bibliographies to summarize the current state of knowledge regarding altered PK in response to inflammation and its application to the field of HIV...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
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