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Expired drugs

Dae Young Lee, Ju-Hyun Kim, Hyun Joo Shim, Hyeon-Uk Jeong, Hye Suk Lee
The objective of this study was to determine the absorption, excretion, and metabolism of a novel, oral antihyperglycemic drug, evogliptin, in male rats and dogs. Plasma, urine, feces, and expired air samples were collected after a single oral dose administration of [14 C]evogliptin, samples were analyzed by measuring overall radioactivity levels using high-performance liquid chromatography (HPLC), and radioactivity levels were measured by utilizing LC-tandem mass spectrometry (LC-MS/MS). The total amounts of radioactivity excreted in urine, feces, and expired air up to 168 h after administration of [14 C]evogliptin tartrate to rats (30 mg evogliptin/kg) and dogs (10 mg evogliptin/kg) were 96...
March 20, 2018: Journal of Toxicology and Environmental Health. Part A
Margaret R Caplan, Eric S Daar, Katya C Corado
Treatment options for patients with HIV-1 infection have grown over the past two decades to include multiple fixed-dose combination pharmacotherapies that have greatly simplified administration of antiretroviral therapy (ART) for both patients and providers. Effective virologic control can often be achieved with once-daily use of a single-tablet regimen. Over the past three years, ART drug development has focused on the next generation of fixed-dose combinations for initial and maintenance therapy with improved efficacy, safety and tolerability...
March 20, 2018: Expert Opinion on Pharmacotherapy
Jose-Manuel Carrascosa, Ira Jacobs, Danielle Petersel, Robert Strohal
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis...
March 16, 2018: Dermatology and Therapy
Isabel Cuesta-López, Marina Sánchez-Cuervo, Ángel Candela-Toha, Juana Benedí-González, Teresa Bermejo-Vicedo
OBJECTIVE: To evaluate the efficiency of the protocolization and centralization of  the preparation of intravenous vasoactive drug mixtures in the treatment of  critically ill patients. METHOD: A prospective interventional study (July 2012-December 2014) was  conducted to measure the impact of different vasoactive drug protocols on costs  in the treatment of critically ill patients. The economic impact was measured by  comparing the direct costs (fixed and variable) of the preparation of intravenous  vasoactive drug mixtures in the Pharmacy Department with their traditional  preparation in hospital care units...
March 1, 2018: Farmacia Hospitalaria
Luba Yammine, Thomas R Kosten, Paul M Cinciripini, Charles E Green, Janet C Meininger, Jennifer A Minnix, Thomas F Newton
BACKGROUND: Cigarette smoking is the greatest preventable cause of morbidity and premature mortality in the United States. Approved pharmacological treatments for smoking cessation are marginally effective, underscoring the need for improved pharmacotherapies. A novel approach might use glucagon-like peptide-1 (GLP-1) agonists, which reduce alcohol and drug use in preclinical studies. GLP-1 is produced in the intestinal L-cells and in the hindbrain. The peptide maintains glucose homeostasis and reduces food intake...
January 2018: Medicine (Baltimore)
Antonello Di Paolo, Elena Arrigoni
Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products...
February 20, 2018: Drugs
Sebastien Perbet, Daniel Bourdeaux, Alexandre Lenoire, Claire Biboulet, Bruno Pereira, Malha Sadoune, Benoit Plaud, Jean-Marie Launay, Jean-Etienne Bazin, Valerie Sautou, Alexandre Mebazaa, Pascal Houze, Jean-Michel Constantin, Matthieu Legrand
BACKGROUND: Sevoflurane has anti-inflammatory proprieties and short lasting effects making it of interest for procedural sedation in critically ill patients. We evaluated the pharmacokinetics of sevoflurane and metabolites in severely ill burn patients and controls. The secondary objective was to assess potential kidney injury. METHODS: prospective interventional study in a burn and a surgical intensive care unit 24 mechanically ventilated critically ill patients (12 burns, 12 controls) were included,...
February 15, 2018: Anaesthesia, Critical Care & Pain Medicine
Reyes Gámez-Belmonte, Cristina Hernández-Chirlaque, María Arredondo-Amador, Carlos J Aranda, Raquel González, Olga Martínez-Augustin, Fermín Sánchez de Medina
Biosimilars are copies of reference biological drugs, developed as the patents for original biologicals expire. They are thus developed to replicate an original biological medicine just a generics are intended to replicate a chemically-synthesized medicine; however, there are important technical and regulatory differences between the two. Unlike chemical drugs, molecular identity cannot generally be established for any two biological drugs. Accordingly, their pharmacological properties cannot be assumed to be the same...
February 8, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Don Husereau, Brian Feagan, Carl Selya-Hammer
Biosimilars are becoming increasingly available internationally as patents expire on the originator biologic drugs they are intended to copy. Although substitution policies seen with generic drugs are being considered as a means to reduce expenditures on biologics, some biosimilars pose particular challenges in that the act of substitution may eventually lead to increased rates of therapeutic failure. As evidence requirements from regulators do not directly address this challenge, switch trials of biosimilars have emerged that may provide further answers...
February 6, 2018: Applied Health Economics and Health Policy
J Braun, H M Lorenz, U Müller-Ladner, M Schneider, H Schulze-Koops, Ch Specker, A Strangfeld, U Wagner, T Dörner
The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product...
January 30, 2018: Zeitschrift Für Rheumatologie
Ahmet Akici, Volkan Aydin, Arzu Kiroglu
Objective: Keeping unnecessary drugs at home is a situation showing both causes and consequences of irrational use of medicine. This study aimed to evaluate the approaches of a company's employees regarding drug storage, use, and disposal. Method: This online-based descriptive study was held in a multi-centered private-sector company in a voluntary basis. The survey assessing participants' drug handling and storage behaviors was answered by 1121 employees from across eight provinces of Turkey in 2016...
January 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Surupa Basu, Biplab Maji, Santanu Barman, Apurba Ghosh
Hemophagocytic lymphohistiocytosis (HLH) is an inflammatory condition that may run a rapid fatal course and calls for prompt diagnosis. Early intervention with steroids and other immunosuppressive drugs can contain the disease process and favours positive outcome. Ferritin ≥500 ng/ml is a HLH diagnostic criterion. We evaluated the diagnostic potential of admission ferritin, in children with HLH. Pediatric patients of a referral teaching hospital from Feb 2010-Oct 2013 having been investigated for ferritin on admission were included...
January 2018: Indian Journal of Clinical Biochemistry: IJCB
Sarah Bledsoe, Alex Van Buskirk, R James Falconer, Andrew Hollon, Wendy Hoebing, Sladan Jokic
PURPOSE: The effectiveness of barcode-assisted medication preparation (BCMP) technology on detecting oral liquid dose preparation errors. METHODS: From June 1, 2013, through May 31, 2014, a total of 178,344 oral doses were processed at Children's Mercy, a 301-bed pediatric hospital, through an automated workflow management system. Doses containing errors detected by the system's barcode scanning system or classified as rejected by the pharmacist were further reviewed...
February 1, 2018: American Journal of Health-system Pharmacy: AJHP
Maryanne Demasi
Statins are the most widely prescribed, cholesterol-lowering drugs in the world. Despite the expiration of their patents, revenue for statins is expected to rise, with total sales on track to reach an estimated US$1 trillion by 2020. A bitter dispute has erupted among doctors over suggestions that statins should be prescribed to millions of healthy people at low risk of heart disease. There are concerns that the benefits have been exaggerated and the risks have been underplayed. Also, the raw data on the efficacy and safety of statins are being kept secret and have not been subjected to scrutiny by other scientists...
January 21, 2018: British Journal of Sports Medicine
M Margarida Castel-Branco, Ana Fontes, Isabel V Figueiredo
Background: A correct selection of drugs prescribed, but also the choice of the appropriate inhaler device, is crucial for the control of respiratory diseases. Objective: To evaluate the inhaler technique and identify potential errors of patients when treated with inhalers by testing a routinary procedure to be implemented in any community pharmacy. Methods: Adults with asthma/COPD and under inhalation therapy were invited to demonstrate how they use their inhalers...
October 2017: Pharmacy Practice
Markus Zilker, Fritz Sörgel, Ulrike Holzgrabe
Pharmaceutical manufacturers have to study the stability of drug products before marketing according to ICH guideline Q1A(R2); data of those investigations aim to set expiry dates. The expiry date on the container of a remedy assures the physician and the patient a stability of the drug in its formulation i.e. within a specification of 95-105%. Only few studies show that shelf-lives of pharmaceutical products are often longer than expiration dates. The objective of the study presented here was determining the content of nine expired ampoules manufactured in the last century and identifying the impurity profile by means of HPLC-UV and HPLC-MS, respectively...
December 13, 2017: Journal of Pharmaceutical and Biomedical Analysis
Gerhardt Konig, Jonathan H Waters, Eric Hsieh, Bridget Philip, Vicki Ting, Gaurav Abbi, Mazyar Javidroozi, Griffeth W Tully, Gregg Adams
BACKGROUND: Clinicians are tasked with monitoring surgical blood loss. Unfortunately, there is no reliable method available to assure an accurate result. Most blood lost during surgery ends up on surgical sponges and within suction canisters. A novel Food and Drug Administration-cleared device (Triton system; Gauss Surgical, Inc, Los Altos, CA) to measure the amount of blood present on sponges using computer image analysis has been previously described. This study reports on performance of a complementary Food and Drug Administration-cleared device (Triton Canister System; Gauss Surgical, Inc, Los Altos, CA) that uses similar image analysis to measure the amount of blood in suction canisters...
February 2018: Anesthesia and Analgesia
Maya Tannoury, Zouhair Attieh
Emerging markets represent an exceptional opportunity for the pharmaceutical industry. Although a precise definition is not yet available, economists define emerging markets as developing prosperous countries in which investment is expected to result in higher income despite high risks. Qualifying a market as emerging is not merely based on the economic status of the country, but also on several criteria that render the definition applicable to each country. Jim O'Neil, retired chairman of asset management at Goldman Sachs, identified leading economies of emerging markets: Brazil, Russia, India, and China (BRIC) and later Brazil, Russia, India, China, and South Africa (BRICS) and then Mexico, Indonesia, South Korea, and Turkey (MIST), which followed years later as the second tier of nations...
2017: Current Therapeutic Research, Clinical and Experimental
Sizheng Zhao, Jagdish R Nair, Robert J Moots
BACKGROUND: Biologic drugs have revolutionised the management of many inflammatory conditions. Patent expirations have stimulated development of highly similar but non-identical molecules, the biosimilars. Extrapolation of indications is a key concept in the development of biosimilars. However, this has been met with concerns around mechanisms of action, equivalence in efficacy and immunogenicity, which are reviewed in this article. METHODS: Narrative overview composed from literature search and the authors' experience...
November 29, 2017: Current Pharmaceutical Design
Tasha R Serna-Gallegos, Christopher J LaFargue, Krishnansu S Tewari
BACKGROUND: Fully humanized monoclonal antibodies have revolutionized the treatment of many solid tumors, including breast, lung, colorectal, and ovarian cancer. Among the most widely used monoclonal antibodies in clinical oncology are cetuximab, trastuzumab, rituximab, and bevacizumab. OBJECTIVE: This article will review these four notable monoclonal antibodies, their role in clinical oncology, and the drug patents that are nearing expiration. RESULTS: They are used in both first and second line treatment regimens for multiple common malignancies...
November 22, 2017: Recent Patents on Biotechnology
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