keyword
MENU ▼
Read by QxMD icon Read
search

Generic drug

keyword
https://www.readbyqxmd.com/read/28445611/equivalence-of-complex-drug-products-advances-in-and-challenges-for-current-regulatory-frameworks
#1
Leonie Hussaarts, Stefan Mühlebach, Vinod P Shah, Scott McNeil, Gerrit Borchard, Beat Flühmann, Vera Weinstein, Sesha Neervannan, Elwyn Griffiths, Wenlei Jiang, Elena Wolff-Holz, Daan J A Crommelin, Jon S B de Vlieger
Biotechnology and nanotechnology provide a growing number of innovator-driven complex drug products and their copy versions. Biologics exemplify one category of complex drugs, but there are also nonbiological complex drug products, including many nanomedicines, such as iron-carbohydrate complexes, drug-carrying liposomes or emulsions, and glatiramoids. In this white paper, which stems from a 1-day conference at the New York Academy of Sciences, we discuss regulatory frameworks in use worldwide (e.g., the U...
April 26, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28445102/journey-of-generic-imatinib-a-case-study-in-oncology-drug-pricing
#2
Christopher T Chen, Aaron S Kesselheim
No abstract text is available yet for this article.
April 26, 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28444005/promoting-and-regulating-generic-medicines-brazil-in-comparative-perspective
#3
Elize Massard da Fonseca, Kenneth C Shadlen
Promoting the use of generic drugs can constitute a core instrument for countries' national pharmaceutical policies, one that reduces drug expenditure while expanding health care access. Despite the potential importance of such policy measures and the differences among national practices, scholars embarking on comparative analysis lack a roadmap for determining which dimensions of generic drug policy to assess and compare. This report fills that gap by considering national rules and regulations across four dimensions deemed crucial to any evaluation: demonstrated therapeutic equivalence; pharmaceutical packaging and labeling; drug prescription; and drug substitution...
April 20, 2017: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
https://www.readbyqxmd.com/read/28435140/biowaiver-monographs-for-immediate-release-solid-oral-dosage-forms-enalapril
#4
REVIEW
Roger K Verbeeck, Isadore Kanfer, Raimar Löbenberg, Bertil Abrahamsson, Rodrigo Cristofoletti, D W Groot, Peter Langguth, James E Polli, Alan Parr, Vinod P Shah, Mehul Mehta, Jennifer B Dressman
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the marketing authorization of immediate release, solid oral dosage forms containing enalapril maleate are reviewed. Enalapril, a prodrug, is hydrolyzed by carboxylesterases to the active angiotensin-converting enzyme inhibitor enalaprilat. Enalapril as the maleate salt is shown to be highly soluble, but only 60 to 70% of an orally administered dose of enalapril is absorbed from the gastrointestinal tract into the enterocytes...
April 20, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28431621/two-decades-of-glatiramer-acetate-from-initial-discovery-to-the-current-development-of-generics
#5
REVIEW
Bianca Weinstock-Guttman, Kavita V Nair, Joseph L Glajch, Tanmoy C Ganguly, Daniel Kantor
Multiple sclerosis (MS) is a chronic, incurable, inflammatory disease of the central nervous system (CNS). In the United States, several US Food and Drug Administration (FDA)-approved disease-modifying treatments (DMTs) are available, including glatiramer acetate (GA; Copaxone®), one of the most longstanding treatments. GA was discovered serendipitously in the late 1960s/early 1970s while attempting to produce a synthetic antigen capable of inducing experimental autoimmune encephalomyelitis (EAE), an animal model of autoimmune inflammatory CNS disorders, including MS...
May 15, 2017: Journal of the Neurological Sciences
https://www.readbyqxmd.com/read/28431584/monitoring-quality-and-coverage-of-harm-reduction-services-for-people-who-use-drugs-a-consensus-study
#6
Lucas Wiessing, Marica Ferri, Vendula Běláčková, Patrizia Carrieri, Samuel R Friedman, Cinta Folch, Kate Dolan, Brian Galvin, Peter Vickerman, Jeffrey V Lazarus, Viktor Mravčík, Mirjam Kretzschmar, Vana Sypsa, Ana Sarasa-Renedo, Anneli Uusküla, Dimitrios Paraskevis, Luis Mendão, Diana Rossi, Nadine van Gelder, Luke Mitcheson, Letizia Paoli, Cristina Diaz Gomez, Maitena Milhet, Nicoleta Dascalu, Jonathan Knight, Gordon Hay, Eleni Kalamara, Roland Simon, Catherine Comiskey, Carla Rossi, Paul Griffiths
BACKGROUND AND AIMS: Despite advances in our knowledge of effective services for people who use drugs over the last decades globally, coverage remains poor in most countries, while quality is often unknown. This paper aims to discuss the historical development of successful epidemiological indicators and to present a framework for extending them with additional indicators of coverage and quality of harm reduction services, for monitoring and evaluation at international, national or subnational levels...
April 22, 2017: Harm Reduction Journal
https://www.readbyqxmd.com/read/28428513/-comparison-of-preparation-efficiency-and-therapeutic-safety-between-generic-products-of-gemcitabine
#7
Yuhki Sato, Hiroyuki Ono, Kohei Amada, Ryosuke Nakahara, Hiroki Itoh
Because generic medicines reduce the financialburden on patients and medicalinsurance providers, they have become increasingly popular. However, there are only a few reports that have analyzed the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects. Gemcitabine is an antineoplastic drug that is frequently used with good results in the treatment of lung cancer, pancreatic cancer, breast cancer, ovarian cancer, and malignant lymphoma. However, its fat solubility is high, and several adverse events, such as myelosuppression, are known to develop during its use...
April 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28425236/predictors-of-health-related-quality-of-life-in-childhood-epilepsy-and-comparison-with-healthy-children-findings-from-an-indian-study
#8
Dipika Bansal, Chandrika Azad, Kapil Gudala, Anil Dasari
BACKGROUND/AIM: Children with epilepsy have reduced health-related quality of life (HRQOL) due to disease and medications. We aimed to assess child-reported HRQOL in Indian children with epilepsy and compare it with that in healthy children. MATERIALS AND METHODS: A cross-sectional study of 256 children with epilepsy aged between 5 and 18 years on antiepileptic drug (AED) treatment for at least 3 months was performed and 125 age and sex matched healthy children were included...
April 18, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/28416417/in-vitro-evaluation-of-nasogastric-ng-tube-delivery-performance-of-esomeprazole-magnesium-delayed-release-capsules
#9
Alicia Hoover, Dajun Sun, Hong Wen, Wenlei Jiang, Minglei Cui, Xiaojian Jiang, David Keire, Changning Guo
Enteral feeding tubes are used to deliver food or drugs to patients that cannot swallow. To deliver delayed-release drugs that are formulated as enteric coated granules to these patients via feeding tubes requires that they be suspended in water prior to administration. Importantly, the suspension of enteric granules in water of varying pH can cause damage to the enteric coating and affect the bioavailability of the drug. Here, analytical methods for testing acid resistance stability and particle size distribution (PSD) of esomeprazole granules were utilized to monitor the integrity of the granule enteric coating after water pretreatment and delivery through an oral syringe and nasogastric (NG) tube...
April 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28408012/comparing-generic-and-condition-specific-preference-based-measures-in-epilepsy-eq-5d-3l-and-newqol-6d
#10
COMPARATIVE STUDY
Brendan Mulhern, Joshua Pink, Donna Rowen, Simon Borghs, Thomas Butt, Dyfrig Hughes, Antony Marson, John Brazier
BACKGROUND: There is debate about the psychometric characteristics of the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) for use in epilepsy. In response to the concerns, an epilepsy-specific preference-based measure (NEWQOL-6D) was developed. The psychometric characteristics of the NEWQOL-6D, however, have not been assessed. OBJECTIVES: To investigate the validity and responsiveness of the EQ-5D-3L and the Quality of Life in Newly Diagnosed Epilepsy Instrument-six dimensions (NEWQOL-6D) for use in the assessment of treatments for newly diagnosed focal epilepsy...
April 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28402764/ensuring-access-to-injectable-generic-drugs-the-case-of-intravesical-bcg-for-bladder-cancer
#11
Benjamin J Davies, Thomas J Hwang, Aaron S Kesselheim
In November 2016, one of the two manufacturers of bacille Calmette–Guérin (BCG) informed health care providers that it planned to exit the market in mid-2017. Intravesical immunotherapy with BCG is the standard of treatment for preventing recurrence and disease progression in high-risk patients..
April 13, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28402145/the-effect-of-ph-buffer-capacity-and-ionic-strength-on-quetiapine-fumarate-release-from-matrix-tablets-prepared-using-two-different-polymeric-blends
#12
Rania Hamed, Reem AlJanabi, Suhair Sunoqrot, Aiman Abbas
The objective of this study was to investigate the effect of the different physiological parameters of the gastrointestinal (GI) fluid (pH, buffer capacity, and ionic strength) on the in vitro release of the weakly basic BCS class II drug quetiapine fumarate (QF) from two once-a-day matrix tablet formulations (F1 and F2) developed as potential generic equivalents to Seroquel(®) XR. F1 tablets were prepared using blends of high and low viscosity grades of hydroxypropyl methylcellulose (HPMC K4M and K100LV, respectively), while F2 tablets were prepared from HPMC K4M and PEGylated glyceryl behenate (Compritol(®) HD5 ATO)...
April 12, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28400466/substance-use-among-men-who-have-sex-with-men-patterns-motivations-impacts-and-intervention-development-need
#13
REVIEW
Adam Bourne, Peter Weatherburn
OBJECTIVES: In this narrative review we illustrate the patterns of substance use among gay, bisexual and other men who have sex with men (MSM), including comparisons with heterosexual populations, subgroup analyses and settings of substance use. We also consider explanations and motivations for substance use and the impact of use on sexual health as well as wider health and well-being. Finally, we consider the implications for the provision of MSM-tailored substance use and harm reduction services...
April 11, 2017: Sexually Transmitted Infections
https://www.readbyqxmd.com/read/28400255/association-of-authorized-generic-marketing-with-prescription-drug-spending-on-antidepressants-from-2000-to-2011
#14
Ning Cheng, Tannista Banerjee, Jingjing Qian, Richard A Hansen
OBJECTIVES: Prior research suggests that authorized generic drugs increase competition and decrease prices, but little empirical evidence supports this conclusion. This study evaluated the impact of authorized generic marketing on brand and generic prices. DESIGN: Longitudinal analysis of the household component of the Medical Expenditure Panel Survey. SETTING: Interview panels over 12 years, with a new panel each year. For each panel, 5 rounds of household interviews were conducted over 30 months...
April 8, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28392910/drug-shortages-in-israel-regulatory-perspectives-challenges-and-solutions
#15
Eyal Schwartzberg, Denize Ainbinder, Alla Vishkauzan, Ronni Gamzu
BACKGROUND: Pharmaceutical drug shortages (DSs) are a global problem which presents challenges to countries around the world. Shortages of pharmaceutical products may have a direct detrimental impact on public health and patients' wellbeing by causing delayed, or even lack of, treatment. Moreover, DSs may force both patients and caregivers to use unfamiliar drugs, which could lead to medication errors. The objective of our study was to analyze DSs in Israel during the years 2013-2015, assessing their etiology and exploring the steps taken for their mitigation and prevention...
2017: Israel Journal of Health Policy Research
https://www.readbyqxmd.com/read/28391005/development-and-validation-of-a-general-derivatization-hplc-method-for-the-trace-analysis-of-acyl-chlorides-in-lipophilic-drug-substances
#16
Xiangyuan Zheng, Lan Luo, Jie Zhou, Xiaoling Ruan, Wenyuan Liu, Feng Zheng
Acyl chlorides are important acylating agents in the synthesis of active pharmaceutical ingredients. Determining the residual acyl chlorides in drug substances is a challenge due to their high reactivity and the matrix interferences from drug substances and their related impurities. This paper describes a general derivatization HPLC method for the determination of aromatic and aliphatic acyl chlorides in lipophilic drug substances. Since most drug substances have weak absorptions in the visible range (above 380nm), the nitro-substituted anilines and nitro-substituted phenylhydrazines were selected as the derivatization reagents due to their weak basicity and red-shift of UV absorption spectra...
June 5, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28383299/a-cost-savings-analysis-of-a-candidate-universal-antiretroviral-regimen
#17
David Ripin, Vineet R Prabhu
PURPOSE OF REVIEW: Despite significant strides in tackling HIV/AIDS in low-income and middle-income countries (LMICs), many treatment shortcomings remain, with limited drug selection to patients emerging as a critical challenge. The potential cost-savings benefits of adopting newer drugs as near-universal first-line antiretroviral (ARV) regimens that also provide improved clinical outcomes are discussed. RECENT FINDINGS: In the near term, a fixed-dose combination of dolutegravir (DTG or D) with tenofovir disoproxil fumarate (TDF), and either lamivudine or emtricitabine (XTC), that is, tenofovir disoproxil fumarate/XTC/DTG (TXD) (X = XTC), could represent a near-universal first-line antiretroviral regimen offering significant clinical benefit, commodity savings, and overall health system savings...
April 5, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28382928/dna-origami-based-shape-ids-for-single-molecule-nanomechanical-genotyping
#18
Honglu Zhang, Jie Chao, Dun Pan, Huajie Liu, Yu Qiang, Ke Liu, Chengjun Cui, Jianhua Chen, Qing Huang, Jun Hu, Lianhui Wang, Wei Huang, Yongyong Shi, Chunhai Fan
Variations on DNA sequences profoundly affect how we develop diseases and respond to pathogens and drugs. Atomic force microscopy (AFM) provides a nanomechanical imaging approach for genetic analysis with nanometre resolution. However, unlike fluorescence imaging that has wavelength-specific fluorophores, the lack of shape-specific labels largely hampers widespread applications of AFM imaging. Here we report the development of a set of differentially shaped, highly hybridizable self-assembled DNA origami nanostructures serving as shape IDs for magnified nanomechanical imaging of single-nucleotide polymorphisms...
April 6, 2017: Nature Communications
https://www.readbyqxmd.com/read/28381916/republicans-resolve-to-address-high-drug-prices-rhetoric-meets-reality-with-ppaca-replacement
#19
Stephen Barlas
As legislation is drafted to replace Obamacare, pharmaceutical issues-including controlling drug prices, expanding or contracting drug access, and incentivizing the development of generic drugs-are expected to be at the forefront of debate.
April 2017: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/28381720/practice-of-regulatory-science-development-of-medical-devices
#20
Shingo Niimi
 Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
keyword
keyword
86663
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"