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Pre-market approval

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https://www.readbyqxmd.com/read/28366835/emerging-therapeutic-uses-of-direct-acting-oral-anticoagulants-an-evidence-based-perspective
#1
REVIEW
Emanuel Raschi, Matteo Bianchin, Roberto De Ponti, Fabrizio De Ponti, Walter Ageno
Direct-acting oral anticoagulants (DOACs) were claimed to cause a potential paradigm shift in the therapeutic scenario of patients requiring short- and long-term anticoagulation, by virtue of their pharmacological properties, perceived as innovative. The evidence gathered so far (from pre-approval pivotal trials to real-world post-marketing observational data) consistently confirmed that DOACs are overall comparable to vitamin-K antagonists (VKAs) in terms of safety, efficacy and effectiveness and unequivocally documented a consistent and clinically relevant reduced risk of intracranial bleeding in the settings of non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE)...
March 31, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28363206/recent-developments-in-the-science-of-proarrhythmic-cardiac-safety-of-new-drugs
#2
J Rick Turner, Dilip R Karnad, Christopher H Cabell, Snehal Kothari
Following marketing withdrawals of several drugs due to proarrhythmic safety concerns, the ICH Guidelines S7B and E14 were released in 2005 and have guided pre-approval cardiac safety assessments in multiple regulatory jurisdictions. While this S7B-E14 paradigm has successfully prevented drugs with unanticipated potential for inducing Torsades de Pointes entering the market, it has unintentionally resulted in the termination of development programs for potentially important compounds that could have exhibited a favourable benefit-risk balance...
April 1, 2017: European Heart Journal. Cardiovascular Pharmacotherapy
https://www.readbyqxmd.com/read/28342075/evaluation-of-pre-marketing-factors-to-predict-post-marketing-boxed-warnings-and-safety-withdrawals
#3
Andreas Schick, Kathleen L Miller, Michael Lanthier, Gerald Dal Pan, Clark Nardinelli
INTRODUCTION: An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions...
March 24, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28211195/a-comparison-of-the-new-japanese-expedited-approval-legislation-for-regenerative-medicine-product-with-the-existing-systems-of-the-united-states-and-european-union
#4
Yoji Jokura, Kazuo Yano, Masayuki Yamato
Expedited approval pathways/programs for drugs, biologics, or medical devices have been enacted for rapid product commercialization of innovative products in the United States (US) and European Union (EU). However, less innovative products are increasingly using these expedited pathways and frequently obligations to collect and report post-marketing data on approved products are being bypassed. The Japanese government recently enacted a new conditional and time-limited approval pathway dedicated to regenerative medicine products...
February 17, 2017: Journal of Tissue Engineering and Regenerative Medicine
https://www.readbyqxmd.com/read/28170304/hiv-pre-exposure-prophylaxis-and-postexposure-prophylaxis-in-japan-context-of-use-and-directions-for-future-research-and-action
#5
Anthony S DiStefano, Makiko Takeda
Biomedical HIV prevention strategies are playing an increasingly prominent role in addressing HIV epidemics globally, but little is known about their use in Japan, where persistent HIV disparities and a recently stable, but not declining, national epidemic indicate the need for evolving approaches. We conducted an ethnographic study to determine the context of pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) use and to identify directions for future research and action in Japan. We used data from observational fieldwork in the Kansai region and Tokyo Metropolitan Area (n = 178 persons observed), qualitative interviews (n = 32), documents and web-based data sources (n = 321), and email correspondences (n = 9) in the period 2013-2016...
February 2017: AIDS Patient Care and STDs
https://www.readbyqxmd.com/read/28164088/effective-implementation-of-novel-met-pharmacodynamic-assays-in-translational-studies
#6
REVIEW
Apurva K Srivastava, Tony Navas, William G Herrick, Melinda G Hollingshead, Donald P Bottaro, James H Doroshow, Ralph E Parchment
MET tyrosine kinase (TK) dysregulation is significantly implicated in many types of cancer. Despite over 20 years of drug development to target MET in cancers, a pure anti-MET therapeutic has not yet received market approval. The failure of two recently concluded phase III trials point to a major weakness in biomarker strategies to identify patients who will benefit most from MET therapies. The capability to interrogate oncogenic mutations in MET via circulating tumor DNA (ctDNA) provides an important advancement in identification and stratification of patients for MET therapy...
January 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28156442/effect-of-food-on-the-pharmacokinetics-of-dronabinol-oral-solution-versus-dronabinol-capsules-in-healthy-volunteers
#7
D Alexander Oh, Neha Parikh, Varun Khurana, Santosh Vetticaden
199 Background: Dronabinol, a pharmaceutical tetrahydrocannabinol (THC), capsule is approved for anorexia associated with weight loss in patients with AIDS and for cancer chemotherapy-induced nausea/vomiting in patients with inadequate response to conventional antiemetic therapy. Food effects on absorption and bioavailability of a new dronabinol oral solution was compared with marketed capsules. METHODS: In an open-label, single-dose, 3-period crossover study, healthy volunteers were randomized to receive dronabinol oral solution 4...
October 9, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28149832/critical-analysis-of-cardiovascular-and-central-nervous-system-fixed-dose-combinations-available-in-indian-market
#8
Krunal Prajapati, Samidh Shah, Mira Desai
INTRODUCTION: Fixed Dose Combinations (FDCs) are being increasingly used to improve compliance and achieve greater benefits of the two or more active ingredients given together than the corresponding individual drug components given separately. AIM: To analyse the rationality of Cardiovascular (CV) and Central Nervous System (CNS) FDCs available in Indian market. MATERIALS AND METHODS: CVS and CNS FDCs, enlisted in Indian Drug Review, 2014, were analysed by a pretested validated eight point criteria tool...
December 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/28070733/glp-1-ra-treatment-patterns-among-type-2-diabetes-patients-in-five-european-countries
#9
Victoria Divino, Mitch DeKoven, Farhad Ali Khan, Kristina S Boye, Hélène Sapin, Kirsi Norrbacka
INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a relatively new class of injectable drugs used in the treatment of type 2 diabetes (T2D). This retrospective database study evaluated real-world treatment patterns of T2D patients initiating GLP-1 RAs in Belgium (BE), France (FR), Germany (DE), The Netherlands (NL) and Sweden (SE). METHODS: Adult T2D patients initiating exenatide twice daily (exBID), exenatide once weekly (exQW), liraglutide (LIRA) or lixisenatide (LIXI) during 2013 were identified using the QuintilesIMS (QuintilesIMS, Durham, NC, and Danbury, CT, USA) longitudinal retail pharmacy databases (LRx; BE/FR/DE/NL) and national health register data (SE)...
February 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28048121/tu-ab-204-01-device-approval-process
#10
J Delfino
The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices...
June 2016: Medical Physics
https://www.readbyqxmd.com/read/27978936/-current-status-of-treatment-of-chronic-hepatitis-c-and-related-challenges-in-the-pre-daa-era-in-china
#11
P Hu, H Ren
The condition of chronic hepatitis C is becoming more and more serious in China, and its disease burden and social and economic burdens are growing heavier. Currently, the standard regimen for the treatment of chronic hepatitis C in China is the PR regimen, namely pegylated interferon combined with ribavirin; however, there are still many shortcomings in this regimen. In the world, there is rapid clinical progress in direct-acting antiviral agents (DAAs) for the treatment of hepatitis C, and DAAs will soon be approved and marketed in China, ushering the "DAA Era" of hepatitis C treatment...
November 20, 2016: Zhonghua Gan Zang Bing za Zhi, Zhonghua Ganzangbing Zazhi, Chinese Journal of Hepatology
https://www.readbyqxmd.com/read/27968891/crowdsourcing-health-communication-about-condom-use-in-men-who-have-sex-with-men-in-china-a-randomised-controlled-trial
#12
Weiming Tang, Jessica Mao, Chuncheng Liu, Katie Mollan, Haochu Li, Terrence Wong, Ye Zhang, Songyuan Tang, Michael Hudgens, Yilu Qin, Baoli Ma, Meizhen Liao, Bin Yang, Wei Ma, Dianmin Kang, Chongyi Wei, Joseph D Tucker
BACKGROUND: The Chinese government now encourages innovation, and more specifically, crowdsourcing. Crowdsourcing, the process of shifting individual tasks to a large group, might reimagine health communication, making it more people-centred. We aimed to compare the effectiveness of a crowdsourced versus social marketing condom promotion video to promote condom use. METHODS: A non-inferiority randomised controlled trial was conducted in November 2015 in China. Men who have sex with men (MSM) aged 16 years or older who reported having had sexual contact without use of a condom in the preceding 3 months were recruited through a nationwide MSM website...
October 2016: Lancet
https://www.readbyqxmd.com/read/27936976/exon-skipping-a-first-in-class-strategy-for-duchenne-muscular-dystrophy
#13
Erik H Niks, Annemieke Aartsma-Rus
Exon skipping is a therapeutic approach for Duchenne muscular dystrophy (DMD) that has been in development for close to two decades. This approach uses antisense oligonucleotides (AONs) to modulate pre-mRNA splicing of dystrophin transcripts to restore the disrupted DMD reading frame. The approach has moved from in vitro proof of concept studies to the clinical trial phase and marketing authorization applications with regulators. The first AON (eteplirsen) has recently received accelerated approval by the Food and Drug Administration in the US...
February 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27881103/demonstration-of-early-efficacy-results-of-the-delayed-release-combination-of-doxylamine-pyridoxine-for-the-treatment-of-nausea-and-vomiting-of-pregnancy
#14
Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok
BACKGROUND: Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin® in Canada and Diclegis® in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies...
November 24, 2016: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/27875916/new-era-in-treatment-options-of-chronic-hepatitis-c-focus-on-safety-of-new-direct-acting-antivirals-daas
#15
REVIEW
Cristina Scavone, Liberata Sportiello, Concetta Rafaniello, Annamaria Mascolo, Maurizio Sessa, Francesco Rossi, Annalisa Capuano
New direct-acting antivirals have changed hepatitis C virus infection management extremely. Areas covered: The pharmacological management of HCV infection and the main characteristics of new DAA therapies have been discussed. In order to analyse safety data regarding DAA therapies, a narrative review was performed searching for safety results of main second generation DAAs pivotal and post-marketing studies. Data on main DAAs drug-drug interactions have also been discussed. Results of main DAAs pivotal studies revealed that these drugs were frequently associated to adverse events such as asthenia, headache, nausea, and insomnia...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27819246/21st-century-pharmacovigilance-efforts-roles-and-responsibilities
#16
REVIEW
Peter J Pitts, Hervé Le Louet, Yola Moride, Rena M Conti
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27777897/chronic-cholestatic-liver-injury-attributable-to-vedolizumab
#17
Jonathan G Stine, Jennifer Wang, Brian W Behm
Drug-induced liver injury is a rare but clinically important diagnosis. Vedolizumab is an α4β7 integrin inhibitor recently approved for use in patients with moderate-to-severe inflammatory bowel disease. Cases of hepatoxicity due to vedolizumab in the pre-marketing stage were rare, and all cases resolved upon drug withdrawal. We present here the first reported case of hepatotoxicity attributable to vedolizumab, which despite drug cessation persisted with chronic cholestatic liver injury.
September 28, 2016: Journal of Clinical and Translational Hepatology
https://www.readbyqxmd.com/read/27754016/br-04-2-concentration-response-modeling-of-antihypertensive-drugs-implication-in-clinical-development
#18
Dong-Seok Yim
In the early phase of clinical development of antihypertensive drugs, quantitative modeling to predict their dose-concentration-response relationship is important to plan future clinical development and finding optimal dosage regimen at marketing approval. Two cases of concentration-response models of antihypertensive are presented here.Case 1: Carvedilol is a α1- and nonselective β- adrenergic receptor antagonist currently used for the management of mild-to-moderate essential hypertension and congestive heart failure...
September 2016: Journal of Hypertension
https://www.readbyqxmd.com/read/27723249/microbial-alkane-production-for-jet-fuel-industry-motivation-state-of-the-art-and-perspectives
#19
REVIEW
Lorena Jiménez-Díaz, Antonio Caballero, Natalia Pérez-Hernández, Ana Segura
Bio-jet fuel has attracted a lot of interest in recent years and has become a focus for aircraft and engine manufacturers, oil companies, governments and researchers. Given the global concern about environmental issues and the instability of oil market, bio-jet fuel has been identified as a promising way to reduce the greenhouse gas emissions from the aviation industry, while also promoting energy security. Although a number of bio-jet fuel sources have been approved for manufacture, their commercialization and entry into the market is still a far way away...
January 2017: Microbial Biotechnology
https://www.readbyqxmd.com/read/27642927/br-04-2-concentration-response-modeling-of-antihypertensive-drugs-implication-in-clinical-development
#20
Dong-Seok Yim
In the early phase of clinical development of antihypertensive drugs, quantitative modeling to predict their dose-concentration-response relationship is important to plan future clinical development and finding optimal dosage regimen at marketing approval. Two cases of concentration-response models of antihypertensive are presented here.Case 1: Carvedilol is a α1- and nonselective β- adrenergic receptor antagonist currently used for the management of mild-to-moderate essential hypertension and congestive heart failure...
September 2016: Journal of Hypertension
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