keyword
MENU ▼
Read by QxMD icon Read
search

"FDA"

keyword
https://www.readbyqxmd.com/read/28214989/exposure-response-analyses-of-blood-pressure-and-heart-rate-changes-for-methylphenidate-in-healthy-adults
#1
Liang Li, Yaning Wang, Ramana S Uppoor, Mehul U Mehta, Tiffany Farchione, Mitchell V Mathis, Hao Zhu
The aim of the study was to evaluate the exposure-response (E-R) relationships of blood pressure (BP) and heart rate (HR) changes in healthy adults taking methylphenidate (MPH). Intensive time profiles of BP and HR from healthy adults in placebo and MPH treatment arms of seven clinical trials from the FDA internal database were utilized for this analysis. The analysis model contains a circadian component for placebo effect and an E-R component to describe drug effect. Internal validation was performed using goodness-of-fit plots and visual predictive check...
February 18, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28214791/a-need-to-stand-united-reply-to-the-wame-secretary
#2
John H Noble
I believe Dr Winker and I agree more than differ about the need for authors of medical journal reports of randomised controlled trial (RCT) findings to acknowledge when they make post hoc adjustments to the original content that they submit to obtain FDA marketing approval for a new drug or medical device.
February 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28214789/-truth-in-research-labelling-regarding-wame-s-quoted-comments
#3
Margaret Winker
We were surprised to read Dr Noble's article, "Truth in research labelling". Dr Noble quotes from an email exchange he and I had regarding a petition that he had asked the World Association of Medical Editors (WAME) to endorse (personal communication, Bernard Carroll and John Noble, September 27, 2016). Unfortunately, the article's description of WAME's comments, which were intended to provide constructive suggestions to improve the petition by ensuring that it was fully supported by facts, is incomplete and the comments have been taken out of context...
February 13, 2017: Indian Journal of Medical Ethics
https://www.readbyqxmd.com/read/28214122/anaerobic-co-digestion-of-recalcitrant-agricultural-wastes-characterizing-of-biochemical-parameters-of-digestate-and-its-impacts-on-soil-ecosystem
#4
Adele Muscolo, Giovanna Settineri, Teresa Papalia, Emilio Attinà, Carmelo Basile, Maria Rosaria Panuccio
Anaerobic digestion (AD) of organic wastes is a promising alternative to landfilling for reducing Greenhouse Gas Emission (GHG) and it is encouraged by current regulation in Europe. Biogas-AD produced, represents a useful source of green energy, while its by-product (digestate) is a waste, that needs to be safely disposal. The sustainability of anaerobic digestion plants partly depends on the management of their digestion residues. This study has been focused on the environmental and economic benefits of co-digest recalcitrant agricultural wastes such olive wastes and citrus pulp, in combination with livestock wastes, straw and cheese whey for biogas production...
February 14, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28213970/efficacy-and-safety-of-immuno-magnetically-sorted-smooth-muscle-progenitor-cells-derived-from-human-induced-pluripotent-stem-cells-for-restoring-urethral-sphincter-function
#5
Yanhui Li, Morgaine Green, Yan Wen, Yi Wei, Prachi Wani, Zhe Wang, Renee Reijo Pera, Bertha Chen
Human-induced pluripotent stem cells (hiPSCs)-based cell therapy holds promise for treating stress urinary incontinence (SUI). However, safety concerns, especially tumorgenic potential of residual undifferentiated cells in hiPSC derivatives, are major barriers for its clinical translation. An efficient, fast and clinical-scale strategy for purifying committed cells is also required. Our previous studies demonstrated the regenerative effects of hiPSC-derived smooth muscle progenitor cells (pSMCs) on the injured urethral sphincter in SUI, but the differentiation protocol required fluorescence-activated cell sorting (FACS) which is not practical for autologous clinical applications...
February 18, 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28213489/summaries-of-safety-labeling-changes-approved-by-fda-boxed-warnings-highlights-october-december-2016
#6
(no author information available yet)
No abstract text is available yet for this article.
March 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28213365/fda-approval-summary-tas-102
#7
Leigh Marcus, Steven J Lemery, Sachia Khasar, Emily Wearne, Whitney S Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur
FDA approved TAS-102 (Lonsurf, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In an international, multicenter, double-blinded, placebo-controlled trial (TPU-TAS-102-301, herein referred to as RECOURSE), 800 patients with previously treated mCRC were randomly allocated (2:1) to receive either TAS-102 35mg/m2 orally twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle (n=534) or matching placebo (n=266)...
February 17, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28213176/lc-ms-ms-assay-for-the-simultaneous-quantitation-of-the-atm-inhibitor-az31-and-the-atr-inhibitor-azd6738-in-mouse-plasma
#8
Brian F Kiesel, Jeffrey C Shogan, Madani Rachid, Robert A Parise, Frank P Vendetti, Christopher J Bakkenist, Jan H Beumer
The ATM kinase inhibitor AZ31 and ATR kinase inhibitor AZD6738 are in various phases of preclinical and clinical evaluation for their ability to potentiate chemoradiation. To support the preclinical evaluation of their pharmacokinetics, we developed and validated an LC-MS/MS assay for the simultaneous quantification of AZ31 and AZD6738 in mouse plasma. A "dilute and shoot" method was used to precipitate proteins from a sample volume of 50μL. Chromatographic separation was achieved using a Phenomenex Polar-RP column and a gradient mobile phase consisting of methanol-water with 0...
February 4, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28212993/efficacy-according-to-blind-independent-central-review-post-hoc-analyses-from-the-phase-iii-randomized-multicenter-ipass-study-of-first-line-gefitinib-versus-carboplatin-paclitaxel-in-asian-patients-with-egfr-mutation-positive-advanced-nsclc
#9
Yi-Long Wu, Nagahiro Saijo, Sumitra Thongprasert, J C-H Yang, Baohui Han, Benjamin Margono, Busayamas Chewaskulyong, Patrapim Sunpaweravong, Yuichiro Ohe, Yukito Ichinose, Jin-Ji Yang, Tony S K Mok, Helen Young, Vincent Haddad, Yuri Rukazenkov, Masahiro Fukuoka
OBJECTIVE: The Phase III, randomized, open-label IPASS study (NCT00322452) of first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) gefitinib versus carboplatin/paclitaxel for Asian patients with advanced non-small-cell lung cancer (NSCLC) showed that investigator-assessed progression-free survival (PFS) and objective response rate (ORR) were significantly prolonged in patients with EGFR mutation-positive NSCLC who received gefitinib versus patients with EGFR mutation-negative NSCLC...
February 2017: Lung Cancer: Journal of the International Association for the Study of Lung Cancer
https://www.readbyqxmd.com/read/28212322/detection-of-salmonella-typhimurium-on-spinach-using-phage-based-magnetoelastic-biosensors
#10
Fengen Wang, Shin Horikawa, Jiajia Hu, Howard C Wikle, I-Hsuan Chen, Songtao Du, Yuzhe Liu, Bryan A Chin
Phage-based magnetoelastic (ME) biosensors have been studied as an in-situ, real-time, wireless, direct detection method of foodborne pathogens in recent years. This paper investigates an ME biosensor method for the detection of Salmonella Typhimurium on fresh spinach leaves. A procedure to obtain a concentrated suspension of Salmonella from contaminated spinach leaves is described that is based on methods outlined in the U.S. FDA Bacteriological Analytical Manual for the detection of Salmonella on leafy green vegetables...
February 16, 2017: Sensors
https://www.readbyqxmd.com/read/28212319/a-validated-stability-indicating-hplc-method-for-simultaneous-determination-of-amoxicillin-and-enrofloxacin-combination-in-an-injectable-suspension
#11
Nidal Batrawi, Shorouq Wahdan, Fuad Al-Rimawi
The combination of amoxicillin and enrofloxacin is a well-known mixture of veterinary drugs; it is used for the treatment of Gram-positive and Gram-negative bacteria. In the scientific literature, there is no high-performance liquid chromatography (HPLC)-UV method for the simultaneous determination of this combination. The objective of this work is to develop and validate an HPLC method for the determination of this combination. In this regard, a new, simple and efficient reversed-phase HPLC method for simultaneous qualitative and quantitative determination of amoxicillin and enrofloxacin, in an injectable preparation with a mixture of inactive excipients, has been developed and validated...
February 16, 2017: Scientia Pharmaceutica
https://www.readbyqxmd.com/read/28211644/healthcare-professionals-and-pharmacovigilance-of-pediatric-adverse-drug-reactions-a-5-year-analysis-of-adverse-events-reporting-system-database-of-the-food-and-drug-administration
#12
Caterina Bigi, Marco Tuccori, Guido Bocci
BACKGROUND: To analyze the Adverse Events Reporting System (AERS) database of the Food and Drug Administration (FDA), investigating the characteristics of pediatric adverse drug reactions (ADRs) and describing the effective participation of healthcare professionals in the reporting activity. METHODS: Reports of ADRs were obtained from the FDA website. Only ADRs in pediatric subjects (divided by age, by country and by professional category) were included into the analysis...
February 17, 2017: Minerva Pediatrica
https://www.readbyqxmd.com/read/28210398/injection-adipolysis-mechanisms-agents-and-future-directions
#13
REVIEW
Shahraam Kamalpour, Keith Leblanc
Noninvasive procedures targeting the elimination of unwanted adipose tissues have recently been developed. injection adipolysis is the term for the injection of cytotoxic substances into these tissues, with the intent of cosmetic improvement by volume reduction. initial attempts in the field utilized intravenous preparations of sodium deoxycholate and soy-derived phosphatidylcholine, approved for the intravenous treatment of fat emboli and dyslipidemias in countries outside the United States. it was initially purported that the active ingredient in these injections was phosphatidylcholine...
December 2016: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/28209496/uterine-leiomyosarcoma-epidemiology-contemporary-treatment-strategies-and-the-impact-of-uterine-morcellation
#14
Stephanie Ricci, Rebecca L Stone, Amanda N Fader
Leiomyosarcoma, a rare tumor subtype, accounts for 1% of all uterine malignancies, but contributes to a significant proportion of uterine cancer deaths. Surgery is considered the mainstay of treatment for all soft tissue sarcomas, including uterine variants. However, uterine leiomyosarcoma is challenging to diagnose preoperatively and can mimic the appearance of benign uterine leiomyomas. Recently, concerns have grown in this regard, as surgeons have utilized uterine morcellation and myomectomy procedures unknowingly in the setting of occult uterine sarcoma...
February 13, 2017: Gynecologic Oncology
https://www.readbyqxmd.com/read/28208749/graphic-warning-labels-and-the-cost-savings-from-reduced-smoking-among-pregnant-women
#15
John A Tauras, Richard M Peck, Kai-Wen Cheng, Frank J Chaloupka
Introduction: The U.S. Food and Drug Administration (FDA) has estimated the economic impact of Graphic Warning Labels (GWLs). By omitting the impact on tobacco consumption by pregnant women, the FDA analysis underestimates the economic benefits that would occur from the proposed regulations. There is a strong link between the occurrence of low birth weight babies and smoking while pregnant. Low birth weight babies in turn generate much higher hospital costs than normal birth weight babies. This study aims to fill the gap by quantifying the national hospital cost savings from the reductions in prenatal smoking that will arise if GWLs are implemented in the U...
February 8, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28207744/utilization-of-smoking-cessation-medication-benefits-among-medicaid-fee-for-service-enrollees-1999-2008
#16
Jennifer Kahende, Ann Malarcher, Lucinda England, Lei Zhang, Paul Mowery, Xin Xu, Varadan Sevilimedu, Italia Rolle
OBJECTIVE: To assess state coverage and utilization of Medicaid smoking cessation medication benefits among fee-for-service enrollees who smoked cigarettes. METHODS: We used the linked National Health Interview Survey (survey years 1995, 1997-2005) and the Medicaid Analytic eXtract files (1999-2008) to assess utilization of smoking cessation medication benefits among 5,982 cigarette smokers aged 18-64 years enrolled in Medicaid fee-for-service whose state Medicaid insurance covered at least one cessation medication...
2017: PloS One
https://www.readbyqxmd.com/read/28207654/long-term-clinical-outcomes-of-cervical-disc-arthroplasty-a-prospective-randomized-controlled-trial
#17
Willa R Sasso, Joseph D Smucker, Maria P Sasso, Rick C Sasso
STUDY DESIGN: Prospective, randomized, single-center, clinical trial. OBJECTIVE: To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change...
February 15, 2017: Spine
https://www.readbyqxmd.com/read/28207238/real-time-monitoring-of-post-surgical-and-post-traumatic-eye-injuries-using-multi-layered-electrical-biosensor-chip
#18
Muhammad Shuja Khan, Santosh K Misra, Aaron Schwartz-Duval, Enrique A Daza, Fatemeh Ostadhossein, Matthew Bowman, Akshay Jain, Gina Taylor, Deana McDonagh, Leanne T Labriola, Dipanjan Pan
Lack of current techniques for the early monitoring of bleb leaks and other post-traumatic or post-surgical ocular injury has posed an unmet clinical need for the development of new techniques. Present evaluation techniques use either subjective or non-quantitative approaches. At present, there are no FDA approved ocular devices that can directly measure ascorbic acid (AA) concentration levels for both tear film (TF) and aqueous humor (AH) at point-of-care (POC) level. Toward this aim, we present a novel point-of-care (POC) quantitative assay, called the Ocular Biosensor device, which can be used to evaluate the integrity of the anterior surface of the eye by measuring the concentration of AA in TF and AH...
February 16, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28206829/validity-of-low-contrast-letter-acuity-as-a-visual-performance-outcome-measure-for-multiple-sclerosis
#19
Laura J Balcer, Jenelle Raynowska, Rachel Nolan, Steven L Galetta, Raju Kapoor, Ralph Benedict, Glenn Phillips, Nicholas LaRocca, Lynn Hudson, Richard Rudick
Low-contrast letter acuity (LCLA) has emerged as the leading outcome measure to assess visual disability in multiple sclerosis (MS) research. As visual dysfunction is one of the most common manifestations of MS, sensitive visual outcome measures are important in examining the effect of treatment. Low-contrast acuity captures visual loss not seen in high-contrast visual acuity (HCVA) measurements. These issues are addressed by the MS Outcome Assessments Consortium (MSOAC), including representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS...
February 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
https://www.readbyqxmd.com/read/28206828/validity-of-the-timed-25-foot-walk-as-an-ambulatory-performance-outcome-measure-for-multiple-sclerosis
#20
Robert W Motl, Jeffrey A Cohen, Ralph Benedict, Glenn Phillips, Nicholas LaRocca, Lynn D Hudson, Richard Rudick
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with multiple sclerosis (MS). One of the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful in MS...
February 1, 2017: Multiple Sclerosis: Clinical and Laboratory Research
keyword
keyword
47310
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"