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https://www.readbyqxmd.com/read/29774560/high-resolution-separation-of-monoclonal-antibodies-mixtures-and-their-charge-variants-by-an-alternative-and-generic-cze-method
#1
Alexandre Goyon, Yannis Nicolas Francois, Olivier Colas, Alain Beck, Jean Luc Veuthey, Davy Guillarme
The determination of mAb critical quality attributes (CQA) is crucial for their successful application in health diseases. A generic CZE method was developed for the high-resolution separation of various mAb charge variants, which are often recognized as important CQA. A dynamic coating of the capillary was obtained with polyethylene oxide (PEO), whereas Bis-Tris allowed the analysis of mAbs under native conditions at pH 7.0. The effect of PEO and Bis-Tris concentrations, as well as the nature of the acidic counter ion on the method performance were systematically studied...
May 17, 2018: Electrophoresis
https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#2
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29768140/addressing-generic-drug-market-failures-the-case-for-establishing-a-nonprofit-manufacturer
#3
Dan Liljenquist, Ge Bai, Gerard F Anderson
Robust competition usually keeps the price of generic drugs well below that of brand-name drugs. When there is little or no competition, however, generic-drug manufacturers can substantially increase prices, and drug shortages may occur. Such market failures can compromise care and negatively..
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29762073/the-association-of-socioeconomic-status-with-severity-of-glaucoma-and-the-impacts-of-both-factors-on-the-costs-of-glaucoma-medications-a-cross-sectional-study-in-west-bengal-india
#4
Tutul Chakravarti
PURPOSE: To evaluate the association of socioeconomic status (SES) with severity of glaucoma and assess the impacts of both SES and disease-severity factors on the costs of glaucoma medications among different glaucoma subtypes in West Bengal, India. METHODS: This cross-sectional study (2014-16) followed the treatment of 304 primary glaucoma patients for at least 18 months. The visual field based glaucoma staging was followed for stages 0-3; patients with field of vision <10° were categorized as stage 4 (end stage)...
May 15, 2018: Journal of Ocular Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29758302/plasminogen-binding-inhibitors-demonstrate-unwanted-activities-on-gaba-a-and-glycine-receptors-in-human-ipsc-derived-neurons
#5
Lisbeth Kristensson, Anders Lundin, David Gustafsson, Jan Fryklund, Tomas Fex, Delsing Louise, Erik Ryberg
Plasminogen binding inhibitors (PBIs) reduce the risk of bleeding in hemorrhagic conditions. However, generic PBIs are also associated with an increased risk of seizures, an adverse effect linked to unwanted activities towards inhibitory neuronal receptors. Development of novel PBIs serve to remove compounds with such properties, but progress is limited by a lack of higher throughput methods with human translatability. Herein we apply human induced pluripotent stem cell (hiPSC) derived neurons in combination with dynamic mass redistribution (DMR) technology to demonstrate robust and reproducible modulation of both GABAA and glycine receptors...
May 11, 2018: Neuroscience Letters
https://www.readbyqxmd.com/read/29757930/comprehension-of-top-200-prescribed-drugs-in-the-us-as-a-resource-for-pharmacy-teaching-training-and-practice
#6
Andrea V Fuentes, Moises D Pineda, Kalyan C Nagulapalli Venkata
Pharmacists have access to a plethora of information related to drugs. Online compendia concerning top 200 prescribed drugs are readily-accessible, comparatively-easy to search. While these resources provide some information about the commonly prescribed drugs, they lack in furnishing in-depth knowledge to pharmacy students, pharmacists and other healthcare professionals. The aim of this paper is to present the relevant details of top 200 most prescribed drugs in the United States. The names and therapeutic classes of top 200 prescribed drugs were compiled from online resources...
May 14, 2018: Pharmacy (Basel, Switzerland)
https://www.readbyqxmd.com/read/29757665/comparison-of-compounded-generic-and-innovator-formulated-itraconazole-in-dogs-and-cats
#7
Janelle Renschler, Amanda Albers, Hanna Sinclair-Mackling, Lawrence Joseph Wheat
The triazole antifungal itraconazole may be cost prohibitive in brand name form; therefore, compounded and generic products are often used as alternatives. Itraconazole blood concentrations have not been studied in clinical patients receiving these formulations. Itraconazole bioassay was performed on serum/plasma from 95 dogs and 20 cats receiving itraconazole (compounded from bulk powder, generic pelletized, or brand name) for systemic mycosis treatment. Mean itraconazole concentration was lower in the compounded group (n = 42) as compared with the generic (n = 40) or brand name (n = 33) groups (0...
May 14, 2018: Journal of the American Animal Hospital Association
https://www.readbyqxmd.com/read/29755792/sofosbuvir-plus-daclatasvir-in-treatment-of-chronic-hepatitis-c-genotype-4-infection-in-a-cohort-of-egyptian-patients-an-experiment-the-size-of-egyptian-village
#8
Ossama Ashraf Ahmed, Eslam Safwat, Mohamed Omar Khalifa, Ahmed I Elshafie, Mohamed Hassan Ahmed Fouad, Mohamed Magdy Salama, Gina Gamal Naguib, Mohamed Mahmoud Eltabbakh, Ahmed Fouad Sherief, Sherief Abd-Elsalam
Background and Aims: As indicated by the World Health Organization (WHO), Egypt is positioned as the country with the world's highest prevalence of Hepatitis C virus (HCV). HCV is transmitted through unexamined blood transfusions, different employments of syringes, and poor cleansing, as per the WHO. Our study aimed at screening and management of chronic hepatitis C genotype 4 infected patients in Bardeen village, Sharkeya Governorate, Egypt, with Sofosbuvir plus Daclatasvir, as well as estimating the safety and efficacy of that regimen...
2018: International Journal of Hepatology
https://www.readbyqxmd.com/read/29753369/biosimilars-for-immune-mediated-chronic-diseases-in-primary-care-what-a-practicing-physician-needs-to-know
#9
REVIEW
Steven R Feldman, Jerry Bagel, Shahla Namak
The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i...
May 2018: American Journal of the Medical Sciences
https://www.readbyqxmd.com/read/29749716/comparative-randomized-single-dose-two-way-crossover-open-label-study-to-determine-the-bioequivalence-of-two-formulations-of-dalfampridine-tablets
#10
Abdel Qader Al Bawab, Bashar A Alkhalidi, Esra'a Albarahmieh, Sami M A Qassim, Mohammad A D Al-Saifi
Dalfampridine is a medication that is approved by the US Food and Drug Administration to improve walking impairments in patients with multiple sclerosis (MS). The branded dalfampridine is enormously expensive; hence, the availability of generic dalfampridine will provide better access to the medication, especially for uninsured patients with MS. Bioequivalence studies are demanded by the regulatory authorities to allow the marketing of new generics of dalfampridine. The aim of this study was to assess the bioavailability of the generic (test) and branded (reference) formulations of 10 mg dalfampridine of extended-release tablets after oral administration to healthy adults under fed conditions...
May 11, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29749101/understanding-patient-adherence-and-concerns-with-statins-and-medication-discussions-with-physicians-action-a-survey-on-the-patient-perspective-of-dialogue-with-healthcare-providers-regarding-statin-therapy
#11
Eliot A Brinton
BACKGROUND: Statin therapy is used first-line for cholesterol lowering and prevention of atherosclerotic cardiovascular disease (CVD), but side effects and the potential for drug-drug interactions may complicate its use. Provider-patient communication is essential for shared decision-making, which, in turn, is recommended by guidelines to reduce or overcome these challenges. Unfortunately, relatively little is known about provider-patient communication surrounding statin use. METHOD: We conducted an online survey of 5,014 patients, U...
May 10, 2018: Clinical Cardiology
https://www.readbyqxmd.com/read/29746726/formulation-and-in-vitro-in-vivo-correlation-between-two-candesartan-cilexetil-tablets
#12
Abdel Naser Zaid, Asma Radwan, Nidal Jaradat, Ayman Mousa, Nadia Ghazal, Rana Bustami
In this study, the in vitro and in vivo interchangeability between generic candesartan 16 mg and the branded formulation was assessed. The in vitro release of these products was conducted in 3 pH media (1.2, 5.0, and 6.8), and similarity factors (f2 ) were calculated. This bioequivalence study was a randomized, 2-period crossover study that included 42 healthy adult male subjects under fasting conditions with a 9-day washout. The pharmacokinetic (PK) parameters AUC0-last , AUC0-∞ , and Cmax , tmax , and the elimination half-life time were assessed based on the plasma concentrations of candesartan, using a newly developed and validated liquid chromatography-tandem mass spectrometry bioanalytical method with acceptable degrees of linearity, sensitivity, precision, and accuracy...
May 10, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29744792/development-and-psychometrics-of-a-short-form-pharmaceutical-care-specific-measure-for-quality-of-life
#13
Phantipa Sakthong, Nontapat Sonsa-Ardjit, Pattarin Sukarnjanaset, Wipaporn Munpan, Todsaporn Sangthonganotai
Background The validated patient-reported outcomes measure of pharmaceutical therapy for quality of life (PROMPT-QoL) contains 43-items, and can be too lengthy for some applications. Objectives To develop a brief version called the PROMPT, and test its psychometric properties. Setting Four public hospitals in Bangkok, Thailand. Method Secondary analysis of three databases used to develop and evaluate the original PROMPT-QoL. Items for the short-form PROMPT were selected based on expert and patient evaluations of content and importance, and lack of redundancy...
May 9, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29743945/evidence-on-the-cost-of-breast-cancer-drugs-is-required-for-rational-decision-making
#14
Anne Margreet Sofie Berghuis, Hendrik Koffijberg, Leonardus Wendelinus Mathias Marie Terstappen, Stefan Sleijfer, Maarten Joost IJzerman
Background: For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology-Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL)...
2018: Ecancermedicalscience
https://www.readbyqxmd.com/read/29742934/drug-information-association-pharmacovigilance-and-risk-management-strategies-2017-overview-of-the-generic-drug-program-and-surveillance
#15
Howard D Chazin, John R Peters, Debra M Catterson, James L Osterhout, Linda M Forsyth, Jung E Lee, Edward K Kim, Karen B Feibus
The US Food and Drug Administration's (FDA's) generic drug program has dramatically increased the availability of affordable, high quality generic drugs. The foundation of generic drug approvals is a two-tiered regulatory framework of pharmaceutical equivalence and bioequivalence. Intrinsic to both of these is consideration of the clinical relevance of formulation and bioequivalence data to support an inference of therapeutic equivalence, based on clear evidence that there are no significant differences between the generic drug and the brand name drug...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29733710/generic-price-competition-for-specialty-drugs-too-little-too-late
#16
Ashley L Cole, Stacie B Dusetzina
The case of generic imatinib demonstrates several potential barriers to effective generic price competition for specialty prescription drugs, including fewer market entrants, smaller-than-expected price reductions, shifts in prescribing toward more expensive brand-name treatments, and limited uptake of the generic product.
May 2018: Health Affairs
https://www.readbyqxmd.com/read/29727755/are-patients-pejorative-representations-of-buprenorphine-associated-with-their-level-of-addiction-and-of-misuse
#17
Paul Vanderkam, Stéphanie Gagey, Pierre Ingrand, Marie-Christine Perault-Pochat, Yann Brabant, Clara Blanchard, Benoit Tudrej, Nassir Messaadi, Philippe Binder
BACKGROUND: In France, buprenorphine is at once the most widely prescribed and the most commonly misused opioid maintenance treatment (OMT). Unlike other medicines, it is seldom prescribed as a generic drug. Several studies have underlined the influence of the patient's representations when choosing brand-name rather than generic forms. We aim to prove a link between these pejorative representations and misuse, a higher degree of addiction and a preference for brand-name products. METHODS: An observational study carried out at 11 sites in France using self-assessment questionnaires filled out in dispensing pharmacies by patients having come to them for buprenorphine delivery...
April 27, 2018: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/29723372/suppression-of-wheal-and-flare-in-histamine-test-by-the-main-h1-antihistamines-commercialized-in-brazil
#18
Helena Maciel-Guerra, Mariana Álvares Penha, Marília Formentini Scotton Jorge, Ricardo da Silva Libório, Ana Cláudia Nazareno Dos Anjos Carrijo, Maria Rita Parise-Fortes, Hélio Amante Miot
BACKGROUND: Several dermatoses are mediated by histamine, such as urticaria, angioedema, and papular urticaria. There are no Brazilian studies comparing the potency of antihistamines. OBJECTIVES: To evaluate the tolerability and efficacy of the main commercial brand and generic H1 antihistamines, regarding the suppression of the wheal and flare to the histamine test. METHODS: A quasi-experimental, open study with 10 healthy adults submitted to the histamine test on the ventral aspect of the forearms...
March 2018: Anais Brasileiros de Dermatologia
https://www.readbyqxmd.com/read/29719976/common-filing-deficiencies-in-abbreviated-new-drug-applications-containing-clinical-endpoint-studies
#19
Lewis J Fermaglich, Ru Chen, Carol Y Kim, Eunjung Esther Chuh, Teena Thomas, Daiva Shetty, Julia Lee, Johnny Young, Ying Fan
BACKGROUND: The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) studies received by the US Food and Drug Administration (FDA) between 2007 and 2017, to help applicants avoid common deficiencies, minimize "refuse-to-receive" (RTR) actions, "information requests," and ANDA approval delays...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29717393/hypertension-in-developing-countries-a-major-challenge-for-the-future
#20
REVIEW
M Mohsen Ibrahim
PURPOSE OF REVIEW: Outline recent epidemiologic data regarding hypertension in developing countries, distinguish differences from developed countries, and identify challenges in management and future perspectives. RECENT FINDINGS: Increased sugar intake, air and noise pollution, and low birth weight are emerging hypertension risk factors. The major challenges in management are difficulties in accurate diagnosis of hypertension and adequate blood pressure control...
May 1, 2018: Current Hypertension Reports
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