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https://www.readbyqxmd.com/read/28766389/pharmacokinetics-efficacy-and-safety-of-the-rituximab-biosimilar-ct-p10
#1
Bertrand Coiffier
Rituximab, an anti-CD20 monoclonal antibody, is a key therapeutic in the treatment of B cell lymphomas and rheumatoid arthritis (RA). Global rates of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL) and RA are increasing, with a concomitant rise in individual and overall treatment costs. As such, biosimilar development may help facilitate greater access to treatment. The rituximab biosimilar CT-P10 (Truxima®) has recently received approval in Europe and South Korea for all indications held by reference rituximab (RTX)...
August 2, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28740620/use-and-cost-comparison-of-clobazam-to-other-antiepileptic-drugs-for-treatment-of-lennox-gastaut-syndrome
#2
Clément François, John M Stern, Augustina Ogbonnaya, Tasneem Lokhandwala, Pamela Landsman-Blumberg, Amy Duhig, Vivienne Shen, Robin Tan
Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28674261/preliminary-evaluation-of-three-dimensional-primary-human-hepatocyte-culture-system-for-assay-of-drug-metabolizing-enzyme-inducing-potential
#3
Hiroshi Arakawa, Hiroki Kamioka, Tomoko Jomura, Satoshi Koyama, Yoko Idota, Kentaro Yano, Hajime Kojima, Takuo Ogihara
Drug-induced liver injury (DILI) is a common reason for withdrawal of candidate drugs from clinical trials, or of approved drugs from the market. DILI may be induced not only by intact parental drugs, but also by metabolites or intermediates, and therefore should be evaluated in the enzyme-induced state. Here, we present a protocol for assay of drug-metabolizing enzyme-inducing potential using three-dimensional (3D) primary cultures of human hepatocytes (hepatocyte spheroids). Hepatocyte spheroids could be used up to 21 d after seeding (pre-culture for 7 d and exposure to inducer for up to 14 d), based on preliminary evaluation of basal activities of CYP subtypes and mRNA expression of the corresponding transcription factor and xenobiotic receptors (aryl hydrocarbon receptor (AhR), constitutive androstane receptor (CAR) and pregnane X receptor (PXR))...
2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28665972/sample-size-determination-for-a-specific-region-in-multiregional-clinical-trials-with-multiple-co-primary-endpoints
#4
Wong-Shian Huang, Hui-Nien Hung, Toshimitsu Hamasaki, Chin-Fu Hsiao
Recently, multi-regional clinical trials (MRCTs), which incorporate subjects from many countries/regions around the world under the same protocol, have been widely conducted by many global pharmaceutical companies. The objective of such trials is to accelerate the development process for a drug and shorten the drug's approval time in key markets. Several statistical methods have been purposed for the design and evaluation of MRCTs, as well as for assessing the consistency of treatment effects across all regions with one primary endpoint...
2017: PloS One
https://www.readbyqxmd.com/read/28637741/the-closed-trial-clonidine-compared-with-midazolam-for-sedation-of-paediatric-patients-in-the-intensive-care-unit-study-protocol-for-a-multicentre-randomised-controlled-trial
#5
Antje Neubert, Manuel Alberto Baarslag, Monique van Dijk, Joost van Rosmalen, Joseph F Standing, Yucheng Sheng, Wolfgang Rascher, Deborah Roberts, Jackie Winslade, Louise Rawcliffe, Sara M Hanning, Tuuli Metsvaht, Viviana Giannuzzi, Peter Larsson, Pavla Pokorná, Alessandra Simonetti, Dick Tibboel
INTRODUCTION: Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation...
June 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28617434/lispro-mitigates-%C3%AE-amyloid-and-associated-pathologies-in-alzheimer-s-mice
#6
Ahsan Habib, Darrell Sawmiller, Song Li, Yang Xiang, David Rongo, Jun Tian, Huayan Hou, Jin Zeng, Adam Smith, Shengnuo Fan, Brian Giunta, Takashi Mori, Glenn Currier, Douglas Ronald Shytle, Jun Tan
Lithium has been marketed in the United States of America since the 1970s as a treatment for bipolar disorder. More recently, studies have shown that lithium can improve cognitive decline associated with Alzheimer's disease (AD). However, the current United States Food and Drug Administration-approved lithium pharmaceutics (carbonate and citrate chemical forms) have a narrow therapeutic window and unstable pharmacokinetics that, without careful monitoring, can cause serious adverse effects. Here, we investigated the safety profile, pharmacokinetics, and therapeutic efficacy of LISPRO (ionic co-crystal of lithium salicylate and l-proline), lithium salicylate, and lithium carbonate (Li2CO3)...
June 15, 2017: Cell Death & Disease
https://www.readbyqxmd.com/read/28464562/pattern-mixture-models-for-clinical-validation-of-biomarkers-in-the-presence-of-missing-data
#7
Fei Gao, Jun Dong, Donglin Zeng, Alan Rong, Joseph G Ibrahim
Targeted therapies for cancers are sometimes only effective in a subset of patients with a particular biomarker status. In clinical development, the biomarker status is typically determined by an investigational-use-only/laboratory-developed test. A market ready test (MRT) is developed later to meet regulatory requirements and for future commercial use. In the USA, the clinical validation of MRT showing efficacy and safety profile of the targeted therapy in the biomarker subgroups determined by MRT is needed for pre-market approval...
May 2, 2017: Statistics in Medicine
https://www.readbyqxmd.com/read/28366835/emerging-therapeutic-uses-of-direct-acting-oral-anticoagulants-an-evidence-based-perspective
#8
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)...
June 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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
REVIEW
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
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