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https://www.readbyqxmd.com/read/28088881/an-industry-update-the-latest-developments-in-therapeutic-delivery
#1
Iain Simpson
This Industry Update covers the period from 1 October through to 31 October 2016, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw several news items covering drug-delivery devices, including a new sensor to monitor and support the use of inhalers; launch in the UK of a new autoinjector for Cimzia(®), UCB's rheumatoid arthritis drug; and approval of Roche's Lucentis(®) in a prefilled syringe. Research was also published to show the value of continuous blood pressure monitoring in dementia management...
February 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28088572/bcs-class-iv-drugs-highly-notorious-candidates-for-formulation-development
#2
REVIEW
Rohan Ghadi, Neha Dand
BCS class IV drugs (e.g., amphotericin B, furosemide, acetazolamide, ritonavir, paclitaxel) exhibit many characteristics that are problematic for effective oral and per oral delivery. Some of the problems associated include low aqueous solubility, poor permeability, erratic and poor absorption, inter and intra subject variability and significant positive food effect which leads to low and variable bioavailability. Also, most of the class IV drugs are substrate for P-glycoprotein (low permeability) and substrate for CYP3A4 (extensive pre systemic metabolism) which further potentiates the problem of poor therapeutic potential of these drugs...
January 11, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28081502/quantitative-determinations-using-portable-raman-spectroscopy
#3
Chelliah V Navin, Chaitanya Tondepu, Roxana Toth, Latevi S Lawson, Jason D Rodriguez
A portable Raman spectrometer was used to develop chemometric models to determine percent (%) drug release and potency for 500mg ciprofloxacin HCl tablets. Parallel dissolution and chromatographic experiments were conducted alongside Raman experiments to assess and compare the performance and capabilities of portable Raman instruments in determining critical drug attributes. All batches tested passed the 30min dissolution specification and the Raman model for drug release was able to essentially reproduce the dissolution profiles obtained by ultraviolet spectroscopy at 276nm for all five batches of the 500mg ciprofloxacin tablets...
December 30, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28074431/detection-and-specific-elimination-of-egfr-ovarian-cancer-cells-using-a-near-infrared-photoimmunotheranostic-approach
#4
Dirk Bauerschlag, Ivo Meinhold-Heerlein, Nicolai Maass, Andreas Bleilevens, Karen Bräutigam, Wa'el Al Rawashdeh, Stefano Di Fiore, Anke Maria Haugg, Felix Gremse, Julia Steitz, Rainer Fischer, Elmar Stickeler, Stefan Barth, Ahmad Fawzi Hussain
PURPOSE: Targeted theranostics is an alternative strategy in cancer management that aims to improve cancer detection and treatment simultaneously. This approach combines potent therapeutic and diagnostic agents with the specificity of different cell receptor ligands in one product. The success of antibody drug conjugates (ADCs) in clinical practice has encouraged the development of antibody theranostics conjugates (ATCs). However, the generation of homogeneous and pharmaceutically-acceptable ATCs remains a major challenge...
January 10, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28062129/-methodological-guideline-for-the-efficacy-and-safety-assessment-of-new-pharmaceuticals-implementation-of-eunethta-s-recommendations
#5
Ruth Ubago Pérez, María Auxiliadora Castillo Muñoz, Mercedes Galván Banqueri, Raúl García Estepa, Eva Rocío Alfaro Lara, María Dolores Vega Coca, Carmen Beltrán Calvo, Teresa Molina López
The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model(®), has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS)...
January 3, 2017: Gaceta Sanitaria
https://www.readbyqxmd.com/read/28056751/safe-and-effective-delivery-of-amphotericin-b-a-survey-of-patents
#6
Subheet Kumar Jain, Lakhvir Kaur, Abhijeet Abhijeet
BACKGROUND: Amphotericin B, designated as the gold standard among antifungal drugs is the only fungicidal effective against systemic fungal infections. But this drug has various pitfalls associated with it, to bypass which various techniques have been employed and resulted in a variety of lipid based commercially available formulations, which demolished only few of the shortcomings associated with this drug. Further, improvement in the delivery systems of Amphotericin B is advancing at increasingly frenetic pace, to surmount its research and to exploit its therapeutic potency with least toxicities...
January 5, 2017: Recent Patents on Nanotechnology
https://www.readbyqxmd.com/read/28053077/animal-research-the-3rs-and-the-internet-of-things-opportunities-and-oversight-in-international-pharmaceutical-development
#7
Steven M Niemi, Gail F Davies
Stages of drug (and vaccine) discovery and evaluation that involve laboratory animals increasingly occur via scientific collaborations across national borders and continents. Many of these research collaborations are between asset-rich institutions and others in less wealthy parts of the world. The care and use of laboratory animals in geographically disparate locations introduces new complexities, such as different oversight requirements and available resources, as well as diverse organizational and cultural milieus...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053072/the-promise-of-new-technologies-to-reduce-refine-or-replace-animal-use-while-reducing-risks-of-drug-induced-liver-injury-in-pharmaceutical-development
#8
Frank D Sistare, William B Mattes, Edward L LeCluyse
Drug induced liver injury (DILI) has contributed more to marketed pharmaceutical withdrawals and clinical development failures than any other human organ toxicity. DILI seen in animal studies also frequently leads to the discontinuation of promising drug candidates very early in the pipeline. This manuscript reviews and critically assesses the current regulatory expectations; the current drug development approaches, strategies, and gaps; and the numerous exciting opportunities becoming available to address these gaps through technological advances...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053065/data-standardization-pharmaceutical-drug-development-and-the-3rs
#9
Laura Kaufman, Katrina Gore, Joyce Chandler Zandee
Despite the efforts, cost, and extensive use of animals for nonclinical research, only a small number of studies have methodically compared findings from animal toxicology studies to those from human clinical trials. Impediments to understanding the translation of nonclinical safety have included the lack of easy access to data and the need for extensive data curation given the diverse terminologies, formats, and data platforms in use. SEND and SDTM study data standards, developed by CDISC and about to become mandated by FDA, can address this and other drug development issues by facilitating access to data in ways that are not currently feasible...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28053064/scientific-knowledge-and-technology-animal-experimentation-and-pharmaceutical-development
#10
Lewis B Kinter, Joseph J DeGeorge
Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times, four major transformations have dramatically impacted pharmaceutical development, each driven by advances in scientific knowledge, technology, and/or regulation: (1) anesthesia, analgesia, and antisepsis; (2) medicinal chemistry; (3) regulatory toxicology; and (4) targeted drug discovery. Animal experimentation in pharmaceutical development is a modern phenomenon dating from the 20th century and enabling several of the four transformations...
December 2016: ILAR Journal
https://www.readbyqxmd.com/read/28049346/genoproteomics-assisted-improvement-of-andrographis-paniculata-toward-a-promising-molecular-and-conventional-breeding-platform-for-autogamous-plants-affecting-the-pharmaceutical-industry
#11
Alireza Valdiani, Daryush Talei, Surrinder K Lattoo, Rodomiro Ortiz, Søren Kjærsgaard Rasmussen, Jacqueline Batley, Mohd Yusop Rafii, Mahmood Maziah, Kallevettankuzhy K Sabu, Rambod Abiri, Suchirat Sakuanrungsirikul, Soon Guan Tan
Andrographis paniculata (Burm. f.) Wall. ex Nees. (AP) is a hermaphroditic, self-compatible, and habitual inbreeding plant. Its main bioactive component is andrographolide, which is capable of inducing autophagic cell death in some human cancer cells and helps fight HIV/AIDS. Increasing the andrographolide content by investigating the genetic mechanisms controlling its biosynthesis in order to improve and develop high-yielding cultivars are the main breeding targets for AP. However, there might exist some limitations or barriers for crossability within AP accessions...
January 3, 2017: Critical Reviews in Biotechnology
https://www.readbyqxmd.com/read/28045654/information-systems-in-clinical-pharmacy-applied-to-parenteral-nutrition-management-and-traceability-a-systematic-review
#12
Josefa Martínez Gabarrón, Javier Sanz-Valero, Carmina Wanden-Berghe
OBJECTIVE: To review the scientific literature on clinical pharmacy information systems applied to parenteral nutrition (PN) management and traceability. METHOD: A systematic review of the documents retrieved from the MEDLINE (PubMed), Web of Science, Scopus, Cochrane Library, International Pharmaceutical Abstracts (IPA) and Google Scholar databases up to May, 2016. The terms used, as descriptors and free text, were: "Parenteral Nutrition" and "Drug Information Services"...
January 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28045653/intelligent-monitoring-system-for-antiviral-pharmacotherapy-in-patients-with-chronic-hepatitis-c-simon-vc
#13
Luis Margusino-Framiñán, Purificación Cid-Silva, Álvaro Mena-de-Cea, Ana Isabel Sanclaudio-Luhía, José Antonio Castro-Castro, Guillermo Vázquez-González, Isabel Martín-Herranz
Two out of six strategic axes of pharmaceutical care in our hospital are quality and safety of care, and the incorporation of information technologies. Based on this, an information system was developed in the outpatient setting for pharmaceutical care of patients with chronic hepatitis C, SiMON-VC, which would improve the quality and safety of their pharmacotherapy. The objective of this paper is to describe requirements, structure and features of Si- MON-VC. Requirements demanded were that the information system would enter automatically all critical data from electronic clinical records at each of the visits to the Outpatient Pharmacy Unit, allowing the generation of events and alerts, documenting the pharmaceutical care provided, and allowing the use of data for research purposes...
January 1, 2017: Farmacia Hospitalaria
https://www.readbyqxmd.com/read/28043165/oromucosal-multilayer-films-for-tailor-made-controlled-drug-delivery
#14
Sandra Lindert, Jörg Breitkreutz
The oral mucosa has recently become increasingly important as an alternative administration route for tailor-made, controlled drug delivery. Oromucosal multilayer films, assigned to the monograph oromucosal preparations in the Ph.Eur. may be a promising dosage form to overcome the requirements related to this drug delivery site. Areas covered: We provide an overview of multilayer films as drug delivery tools, and discuss manufacturing processes and characterization methods. We focus on the suitability of characterization methods for particular requirements of multilayer films...
January 3, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28041695/influence-of-ppcps-on-the-performance-of-intermittently-operated-slow-sand-filters-for-household-water-purification
#15
Caroline M E Pompei, Lena Ciric, Melisa Canales, Kersti Karu, Eny M Vieira, Luiza C Campos
Removal of pharmaceuticals and personal care products (PPCPs) from drinking water is usually enhanced by advanced oxidation which is not affordable in low income countries. Slow sand filtration has been found to be capable of removing anti-inflammatory compounds, and its low maintenance costs and easy operation make it an attractive technology for treating drinking water in many parts of the world. In addition, slow sand filters can be used at both large and household scales. The biofilm (i.e. schmutzdecke) developed on the top of the sand and within the upper layers of the sand is acknowledged to be responsible for the water purification...
December 29, 2016: Science of the Total Environment
https://www.readbyqxmd.com/read/28033035/gelatin-controversies-in-food-pharmaceuticals-and-personal-care-products-authentication-methods-current-status-and-future-challenges
#16
Md Eaqub Ali, Sharmin Sultana, Sharifah Bee Abd Hamid, M A Motalib Hossain, Wageeh A Yehya, Md Abdul Kader, Suresh K Bhargava
Gelatin is a highly purified animal protein of pig, cow and fish origins and is extensively used in food, pharmaceuticals and personal care products. However, the acceptability of gelatin products greatly depends on the animal sources of the gelatin. Porcine and bovine gelatins have attractive features but limited acceptance because of religious prohibitions and potential zoonotic threats, whereas fish gelatin is welcomed in all religions and cultures. Thus, source authentication is a must for gelatin products but it is greatly challenging due to the breakdown of both protein and DNA biomarkers in processed gelatins...
December 29, 2016: Critical Reviews in Food Science and Nutrition
https://www.readbyqxmd.com/read/28028873/development-of-a-qualitative-real-time-pcr-for-microbiological-quality-control-testing-in-mammalian-cell-culture-production
#17
Kerstin Kleinschmidt, Erik Wilkens, Stefanie P Glaeser, Peter Kämpfer, Alexandra Staerk, David Roesti
AIMS: The aim of this study was to develop and evaluate a real-time PCR technology for microbiological control methods to examine individualized cell therapeutics, an emerging class of pharmaceutical formulations. METHODS AND RESULTS: Oligonucleotide primers and hybridization probe for bacterial detection targeting the 16S rRNA gene and were adapted based on Nadkarni et al.; 2002. For detection of yeast and molds, primers and probe were designed from conserved sequences of the 18S rRNA gene in this study...
December 28, 2016: Journal of Applied Microbiology
https://www.readbyqxmd.com/read/28028257/-effectiveness-of-dexrazoxane-for-extravasation-of-anthracycline-antitumor-antibiotics-reporting-measures-developed-against-extravasation-in-the-hospital
#18
Satoshi Kawamoto, Takuya Shirahata, Tetsuya Katori, Takafumi Izumo, Hitomi Kadono, Hiroaki Fujita, Rumiko Okamoto
Dexrazoxane(DXZ)is a drug used for treating extravasation(EV)of anthracycline antitumor antibiotics based on 2 of its mechanisms of action through Topo II. In Japan, it has been used in approximately 150 patients as of January 2016, but there is no detailed report. Three DXZ treatments were carried out for 2 cases in our facilities. One case involved a patient's right forearm while 2 cases occurred involved the left and right forearms of each of the patients, and both were Grade 2(CTCAE v4.0). The EV healed in all cases, and surgical procedures were not needed...
December 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28025921/improving-clinical-decision-support-in-pharmacy-toward-the-perfect-dur-alert
#19
Jenna L Reynolds, Michael T Rupp
: The cornerstone of every health care profession is decision making. Historically, the decisions made by pharmacists have focused on ensuring the accuracy and physical integrity of the pharmaceutical product delivered to the patient in strict compliance with the prescriber's order. As the role of the pharmacist evolved over the past half century, the focus of decision making progressively shifted from a product-centric orientation to optimizing the interaction that occurs between the pharmaceutical product and the patient...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#20
(no author information available yet)
: Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
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