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https://www.readbyqxmd.com/read/29149148/current-impact-and-application-of-abuse-deterrent-opioid-formulations-in-clinical-practice
#1
Ya-Han Lee, Daniel L Brown, Hsiang-Yin Chen
BACKGROUND: Abuse-deterrent formulations (ADFs) represent one novel strategy for curbing the potential of opioid abuse. OBJECTIVE: We aim to compare and contrast the characteristics and applications of current abuse-deterrent opioid products in clinical practice. METHODS: Literature searches were conducted in databases (Pubmed Medline, International Pharmaceutical Abstracts, Google Scholar) and official reports. Relevant data were screened and organized into: 1) epidemiology of opioid abuse, 2) mitigation strategies for reducing opioid abuse, 3) development of ADFs, and 4) clinical experience with these formulations...
November 2017: Pain Physician
https://www.readbyqxmd.com/read/29149126/pharmacogenomics-principles-and-relevance-to-oncology-nursing%C3%A2
#2
Crystal H Dodson
BACKGROUND: Pharmacogenomics is the fastest growing field in precision medicine. Based on current use, oncology encompasses the largest share of the precision medicine market, necessitating that oncology nurses understand the principles of pharmacogenomics and how it affects clinical practice.
. OBJECTIVES: This article will define precision medicine and pharmacogenomics and will provide examples of pharmacogenomic tests, including those associated with tumor markers, and nursing implications...
December 1, 2017: Clinical Journal of Oncology Nursing
https://www.readbyqxmd.com/read/29146462/individual-serum-bile-acid-profiling-in-rats-aids-in-human-risk-assessment-of-drug-induced-liver-injury-due-to-bsep-inhibition
#3
Steven Cepa, David Potter, Lisa Wong, Leah Schutt, Jacqueline Tarrant, Jodie Pang, Xiaolin Zhang, Roxanne Andaya, Laurent Salphati, Yingqing Ran, Le An, Ryan Morgan, Jonathan Maher
Drug-induced liver injury (DILI) has been the most frequent cause of post-marketing drug withdrawals in the last 50years. The multifactorial nature of events that precede severe liver injury in human patients is difficult to model in rodents due to a variety of confounding or contributing factors that include disease state, concurrent medications, and translational species differences. In retrospective analyses, a consistent risk factor for DILI has been the inhibition of the Bile Salt Export Pump (BSEP). One compound known for potent BSEP inhibition and severe DILI is troglitazone...
November 13, 2017: Toxicology and Applied Pharmacology
https://www.readbyqxmd.com/read/29144574/sglt-2-inhibitors-and-ketoacidosis-a-disproportionality-analysis-in-the-world-health-organization-s-adverse-drug-reactions-database
#4
Abdel Nasser Ado Moumouni, Perrine Robin, Dominique Hillaire-Buys, Jean-Luc Faillie
SGLT-2 inhibitors, also called gliflozins, are a new class of drugs used in type 2 diabetes. Since their marketing, several cases of ketoacidosis, including life-threatening conditions, were reported with their use. The objective of this study was to investigate the disproportionality of pharmacovigilance reports of ketoacidosis between gliflozins and other drugs used for type 2 diabetes. We performed a case non-case study within the World Health Organization's pharmacovigilance database, VigiBase. We selected all reports of serious adverse drug reaction associated with a glucose-lowering drug in patients aged 40 years and older, from January 2013 to March 2016...
November 16, 2017: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29141569/isatin-new-hope-against-convulsion
#5
Rameshwar S Cheke, Sandip D Firke, Ravindra R Patil, Sanjay B Bari
Epilepsy is one of the most significant chronic neurological disorders with high occurrence worldwide. Many epileptic patients are not completely treated with currently available marketed drugs as well as so many drugs have shown unfavorable side effect and drug interaction. Therefore, there are continuing interests to find new anticonvulsant drugs. Recently, there has been wide interest in compounds containing the isatin moiety with diverse biological effects. In view of the previous continuation of an ongoing program aiming at finding new structure leads to potential anticonvulsant activities, we are trying to compile recent efforts which have been made in the design and development of isatin derived anticonvulsant agents...
November 13, 2017: Central Nervous System Agents in Medicinal Chemistry
https://www.readbyqxmd.com/read/29141274/use-of-direct-oral-anticoagulants-in-the-first-year-after-market-entry-of-edoxaban-a-danish-nationwide-drug-utilization-study
#6
Anton Pottegård, Erik L Grove, Maja Hellfritzsch
OBJECTIVES: To describe the early uptake of edoxaban; the fourth direct oral anticoagulant (DOAC) to enter the market. METHODS: Using the Danish nationwide health registries, we identified new users of edoxaban (n = 609) from June 6 (day of marketing) through June 2017. For comparison, we also identified new users of dabigatran (n = 2211), rivaroxaban (n = 19 227), and apixaban (n = 14 736). Users were described regarding indication of use, previous anticoagulant experience, comorbidity, and co-medication...
November 15, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29140658/killing-u-s-slowly-curing-the-epidemic-rise-of-cancer-drug-prices
#7
Emily K White
In August 2015, more than 110 U.S. oncologists published an article detailing the deleterious effects of rising cancer drugs prices and calling for numerous reforms to our prescription drug system. These prices are the result of decades of political maneuvering; they reflect the way our country has chosen to pay for healthcare, to foster and reward innovation, and to promote a national free market system. While these choices have resulted in immense profits for pharmaceutical companies—and subsidized the development of prescription drugs globally—they have also left many cancer patients unable to afford their medications...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140657/sunlight-and-other-disinfectants-disclosure-obligations-under-the-federal-securities-and-drug-regulatory-regimes
#8
Joseph G Milner
Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and public markets, SEC and FDA send conflicting signals about the information drug companies need to disclose to the public...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140654/proposed-industry-best-practices-in-development-and-marketing-of-medical-foods-for-the-management-of-chronic-conditions-and-diseases-while-awaiting-regulation
#9
Bruce Burnett, Robert M Levy
Ideal therapeutics have low toxicity and can effectively manage condition(s) or disease(s). The Food & Drug Administration (FDA) marketing category of therapeutics called “medical foods” (MFs) meets such a definition. Medical foods have existed in Federal law since passage the Orphan Drug Act in 1988, which created a category of nutritional therapeutics separate from drugs. Unfortunately, MFs are not widely understood by the medical community or utilized in all patients who need them due to lack of a FDA-approval process, unclear and contradictory guidance especially with regard for need for an investigational new drug (IND) application, and no clear regulations regarding their development and marketing...
2017: Food and Drug Law Journal
https://www.readbyqxmd.com/read/29140469/superdrug2-a-one-stop-resource-for-approved-marketed-drugs
#10
Vishal B Siramshetty, Oliver Andreas Eckert, Björn-Oliver Gohlke, Andrean Goede, Qiaofeng Chen, Prashanth Devarakonda, Saskia Preissner, Robert Preissner
Regular monitoring of drug regulatory agency web sites and similar resources for information on new drug approvals and changes to legal status of marketed drugs is impractical. It requires navigation through several resources to find complete information about a drug as none of the publicly accessible drug databases provide all features essential to complement in silico drug discovery. Here, we propose SuperDRUG2 (http://cheminfo.charite.de/superdrug2) as a comprehensive knowledge-base of approved and marketed drugs...
November 11, 2017: Nucleic Acids Research
https://www.readbyqxmd.com/read/29140125/diabetes-area-patent-participation-analysis-part-ii-years-2011-2016
#11
Markus Boehm, Matthew Crawford, Jamie E Moscovitz, Philip A Carpino
Diabetes is a metabolic disease characterized by elevated levels of plasma glucose. When untreated, diabetes increases the risk of developing co-morbidities such as cardiovascular disease. Several drugs, often used as part of combination therapies, have been approved to treat the disease, but these drugs will eventually fail to effectively control blood glucose levels, at which point insulin replacement therapy is required. A medical need exists for new anti-diabetic drugs that exhibit good efficacy with improved safety/toleration profiles and can be added on top of existing therapies, or that can provide additional benefits beyond glucose lowering such as pancreatic beta (β)-cell protection...
November 15, 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/29139314/cost-utility-analysis-of-life-long-prophylaxis-with-recombinant-factor-viii-fc-vs-recombinant-factor-viii-for-the-management-of-severe-haemophilia-a-in-sweden
#12
Nathaniel Henry, Jelena Jovanović, Max Schlueter, Persefoni Kritikou, Koo Wilson, Karl-Johan Myrén
AIMS: Prophylaxis with recombinant factor VIII (rFVIII) is the standard of care for severe haemophilia A in Sweden. The need for frequent injections with existing rFVIII products may, however, result in poor adherence to prophylaxis leading to increased bleeding and long-term joint damage. Recombinant FVIIIFc (rFVIIIFc) is an extended half-life fusion protein which can offer prolonged protection and reduced dosing frequency. The objective of this study was to evaluate the cost-utility of prophylaxis with rFVIIIFc in severe haemophilia A from the perspective of the Swedish health system...
November 15, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/29139305/development-of-optimized-self-nanoemulsifying-lyophilized-tablets-snelts-to-improve-finasteride-clinical-pharmacokinetic-behavior
#13
Tarek A Ahmed, Khalid M El-Say, Khaled M Hosny, Bader M Aljaeid
OBJECTIVE: Preparation of an optimized finasteride (FSD) lyophilized tablets loaded with self-nanoemulsifying drug delivery system (SNEDDS). SIGNIFICANCE: Enhance FSD bioavailability in male pattern baldness and benign prostatic hyperplasia. METHODS: Two-step optimization was implemented to achieve the study goals. First; mixture design was used to develop an optimized SNEDDS through which the effect of cosurfactant number of carbon atoms on SNEDDS particle size and thermodynamic stability has been tested...
November 15, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/29139259/-progress-in-molecular-identification-of-snake-drugs
#14
REVIEW
Yi Xu, Yan Lu, Hai-Ping Wu, Ying Bu
Snake drugs have high values in clinical medication for anti-inflammatory, analgesia activities and dredging collaterals. However, owing to their deficient resource and substantial profit, many counterfeits for snake drugs have appeared on the market. Traditional methods for Chinese medicine authentication include identification of origin, morphology identification, microscopy and physiochemical identification. But these methods are restricted in application because of their high morphological requirement for specimens, complex process for assays and indeterminate results guided by subjective...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29139248/-post-marketing-safety-surveillance-of-diemailing-kudiezi-injection-real-world-study-in-30-233-cases
#15
Xing Liao, Dan-Dan Yu, Yan-Ming Xie, Yun-Ling Zhang, Yan He, Yin Zhang, Yan Liu, Dan-Hui Yi, Yong-Yan Wang
This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29139247/-systematic-review-on-safety-of-xianling-gubao-capsule
#16
Yi-Li Zhang, Xing Liao, Fu-Mei Liu, Gui-Qian Wang, Yan-Ming Xie
To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule. The literature was screened according to inclusion and exclusion criteria, and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29139145/pharmacokinetic-assessment-of-the-monepantel-plus-oxfendazole-combined-administration-in-dairy-cows
#17
M Ballent, P Viviani, F Imperiale, P Dominguez, S Halwachs, H Mahnke, W Honscha, C Lanusse, G Virkel, A Lifschitz
Monepantel (MNP) is a novel anthelmintic compound launched into the veterinary pharmaceutical market. MNP is not licenced for use in dairy animals due to the prolonged elimination of its metabolite monepantel sulphone (MNPSO2 ) into milk. The goal of this study was to evaluate the presence of potential in vivo drug-drug interactions affecting the pattern of milk excretion after the coadministration of the anthelmintics MNP and oxfendazole (OFZ) to lactating dairy cows. The concentrations of both parent drugs and their metabolites were measured in plasma and milk samples by HPLC...
November 15, 2017: Journal of Veterinary Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29138987/optimized-ciclopirox-based-eudragit-rlpo-nail-lacquer-effect-of-endopeptidase-enzyme-as-permeation-enhancer-on-transungual-drug-delivery-and-efficiency-against-onychomycosis
#18
Abeer Khattab, Samia Shalaby
The aims of our investigation were to develop and optimize ciclopirox (CPX) nail lacquer using nonbiodegradable Eudragit RLPO (E-RLPO) as a film former and to assess its penetration efficiency across the human nail plate. Preliminary trials such as hydration enhancement factor (HEF), a retained drug in the nail plate, and SEM were studied to select the optimized permeation enhancer to be incorporated in the optimized lacquer formulation. A 3(3) full factorial design was built up to study the effect of three different factors, concentration of E-RLPO (10, 20, and 30%), Tween 80 (0...
November 14, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/29138569/post-marketing-observational-program-of-the-effectiveness-of-fluvoxamine-for-the-treatment-of-depression-in-patients-with-neurological-disorders-the-friends-study
#19
Nikolay N Yahno, Anastasia V Fedotova
In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale)...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/29137811/improving-the-safety-of-metal-based-drugs-by-tuning-their-metabolism-with-chemoprotective-agents
#20
Jürgen Gailer
Metal-based drugs remain a tiny minority of all drugs that are on the market. The success story of the quintessential metal-based drug cisplatin (CP), which is intravenously administered to 70% of all cancer patients, however, demonstrates the inherent potential of metal-based drugs. A distinct disadvantage of CP is the dose-limiting severe toxic-side effects that it exerts in patients. To better understand the biomolecular basis for its toxicity, we employed a metallomics method to observe all platinum metabolites that are formed in blood plasma...
November 8, 2017: Journal of Inorganic Biochemistry
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