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pharmaceutical development and technology

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https://www.readbyqxmd.com/read/28429185/high-content-assessment-of-cardiac-function-using-heart-on-a-chip-devices-as-drug-screening-model
#1
Genevieve Conant, Benjamin Fook Lun Lai, Rick Xing Ze Lu, Anastasia Korolj, Erika Yan Wang, Milica Radisic
Drug discovery and development continues to be a challenge to the pharmaceutical industry despite great advances in cell and molecular biology that allow for the design of better targeted therapeutics. Many potential drug compounds fail during the clinical trial due to inefficacy and toxicity that were not predicted during preclinical stages. The fundamental problem lies with the use of traditional drug screening models that still largely rely on the use of cell lines or animal cell monolayers, which leads to lack of predictive power of human tissue and organ response to the drug candidates...
April 20, 2017: Stem Cell Reviews
https://www.readbyqxmd.com/read/28423954/the-design-and-scale-up-of-spray-dried-particle-delivery-systems
#2
Ali Al-Khattawi, Andrew Bayly, Andy Phillips, David Wilson
The rising demand for pharmaceutical particles with tailored physico-chemical properties has opened new markets for the spray drying technology especially for solubility enhancement, improvement of inhalation medicines and stabilization of biopharmaceuticals. Despite this, the literature on spray drying is scattered and often does not address the fundamental principles underpinning the robust development of pharmaceutical products. It is therefore necessary to present a clearer picture of the field and highlight the principles and factors influencing particle design and scale-up...
April 19, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28421428/how-has-cder-prepared-for-the-nano-revolution-a-review-of-risk-assessment-regulatory-research-and-guidance-activities
#3
Katherine M Tyner, Nan Zheng, Stephanie Choi, Xiaoming Xu, Peng Zou, Wenlei Jiang, Changning Guo, Celia N Cruz
The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial...
April 18, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28421296/metabolite-signatures-of-doxorubicin-induced-toxicity-in-human-induced-pluripotent-stem-cell-derived-cardiomyocytes
#4
Umesh Chaudhari, James K Ellis, Vilas Wagh, Harshal Nemade, Jürgen Hescheler, Hector C Keun, Agapios Sachinidis
Drug-induced off-target cardiotoxicity, particularly following anti-cancer therapy, is a major concern in new drug discovery and development. To ensure patient safety and efficient pharmaceutical drug development, there is an urgent need to develop more predictive cell model systems and distinct toxicity signatures. In this study, we applied our previously proposed repeated exposure toxicity methodology and performed (1)H NMR spectroscopy-based extracellular metabolic profiling in culture medium of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) exposed to doxorubicin (DOX), an anti-cancer agent...
April 18, 2017: Amino Acids
https://www.readbyqxmd.com/read/28416645/performance-stability-of-silicon-oxide-coated-plastic-parenteral-vials
#5
Christopher M Weikart, Carlo G Pantano, Jeff R Schallenberger
A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high precision injection-molded plastics and plasma coating technology. The result is a shatter resistant, optically clear, low particulate and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints and product recalls for injectable drugs and biologics packaged in traditional glass materials...
April 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28413148/incorporating-site-less-clinical-trials-into-drug-development-a-framework-for-action
#6
Irl B Hirsch, Joe Martinez, E Ray Dorsey, Gerald Finken, Alexander Fleming, Chris Gropp, Philip Home, Daniel I Kaufer, Spyros Papapetropoulos
PURPOSE: Options for leveraging available telemedicine technologies, ranging from simple webcams and telephones to smartphone apps and medical-grade wearable sensors, are evolving faster than the culture of clinical research. Until recently, most clinical trials relied on paper-based processes and technology. This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development. Alternatives that use existing tools and processes for collecting real-world data in home settings warrant closer examination...
April 13, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28411333/technological-device-for-manufacturing-transdermal-films-possible-applications-to-the-individualized-treatment-for-erectile-dysfunction
#7
Francisco José Raposo, Hudson Caetano Polonini, Anderson Ferreira, Nádia Rezende Barbosa Raposo, Marcos Antônio Fernandes Brandão
Pharmacological advances in erectile dysfunction (ED) treatment have aroused growing interest among health professionals towards sexual dysfunction, generating an increasing demand for dosage forms and drug delivery systems, including tadalafil. This study aimed to develop a device to generate patches that would enable drug dosage individualization and transdermal administration. To create such a mechanical device, technical drawings were made using the CAD software. A functional prototype was built, and a pharmaceutical formulation containing tadalafil (10 mg cm(-2)) was prepared...
April 14, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28407932/a-g-quadruplex-based-fluorescent-oligonucleotide-turn-on-probe-towards-iodides-detection-in-real-samples
#8
Qian Li, Shuaihua Li, Xiu Chen, Liujiao Bian
A basket-type G-quadruplex (GQ) fluorescent oligonucleotide (OND) probe is designed to detect iodides dependent on thymine-Hg(II)-thymine (T-Hg(II)-T) base pairs and the intrinsic fluorescence quenching capacity of GQ. In the presence of Hg(II) ions (Hg(2+)), the two hexachloro-fluorescein-labeled ONDs form a hairpin structure and the fluorophores are dragged close to the GQ, leading to fluorescence quenching of the probe due to photoinduced electron transfer. Upon addition of iodide anions, Hg(2+) are extracted from T-Hg(II)-T complexes which attributes to the stronger binding with iodide anions, resulting in the fluorescence recovery...
September 1, 2017: Food Chemistry
https://www.readbyqxmd.com/read/28405573/spherical-crystallization-a-technique-use-to-reform-solubility-and-flow-property-of-active-pharmaceutical-ingredients
#9
REVIEW
Arindam Chatterjee, Madan Mohan Gupta, Birendra Srivastava
Tablets have been choice of manufacturers over the years due to their comparatively low cost of manufacturing, packaging, shipping, and ease of administration; also have better stability and can be considered virtually tamper proof. A major challenge in formulation development of the tablets extends from lower solubility of the active agent to the elaborated manufacturing procedures for obtaining a compressible granular material. Moreover, the validation and documentation increases, as the numbers of steps increases for an industrially acceptable granulation process...
January 2017: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/28402142/development-of-separation-technology-for-the-removal-of-radium-223-from-targeted-thorium-conjugate-formulations-part-ii-purification-of-targeted-thorium-conjugates-on-cation-exchange-columns
#10
Janne Olsen Frenvik, Knut Dyrstad, Solveig Kristensen, Olav B Ryan
Tumour targeting pharmaceuticals will play a crucial role in future pharma pipelines. The Targeted Thorium Conjugate (TTC) therapeutic platform could provide real benefit to patients, whereby targeting moieties like monoclonal antibodies are radiolabelled with the alpha-emitting radionuclide thorium-227 ((227)Th, t1/2=18.7 days). A potential problem could be the accumulation of the long-lived daughter nuclide radium-223 ((223)Ra, t1/2=11.4 days) in the drug product during manufacture and distribution. Therefore, the level of (223)Ra must be standardised before administration to the patient...
April 12, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28391973/the-current-status-and-problems-confronted-in-delivering-precision-medicine-in-japan-and-europe
#11
REVIEW
Hideaki Bando
Precision medicine has been defined as "a predictive, preventive, personalized, and participatory health care service delivery model." Today, developments in next-generation sequencing and information technology have made precision medicine possible, with massive amounts of genetic, "omics," clinical, environmental, and lifestyle data now available. Unfortunately, differences in governmental support and health care regulations have resulted in heterogeneous progress among countries. In Japan, for example, precision cancer screening and treatments are increasingly being promoted, with collaboration among research, governmental, and pharmaceutical agencies taking place in the nationwide SCRUM-Japan cancer genome screening project...
February 22, 2017: Current Problems in Cancer
https://www.readbyqxmd.com/read/28390750/implementing-ecopharmacovigilance-epv-from-a-pharmacy-perspective-a-focus-on-non-steroidal-anti-inflammatory-drugs
#12
REVIEW
Jun Wang, Bingshu He, Dan Yan, Xiamin Hu
Environmental experts have made great efforts to control pharmaceutical pollution. However, the control of emerged environmental problems caused by medicines should draw more attention of pharmacy and pharmacovigilance researchers. Ecopharmacovigilance (EPV) as a kind of pharmacovigilance for the environment is recognized worldwide as crucial to minimize the environmental risk of pharmaceutical pollutants. But continuing to treat the pollution of pharmaceuticals as a group of substances instead of targeting individual pharmaceuticals on a prioritized basis will lead to a significant waste of resources...
April 5, 2017: Science of the Total Environment
https://www.readbyqxmd.com/read/28389707/the-race-of-10-synthetic-rnai-based-drugs-to-the-pharmaceutical-market
#13
REVIEW
Ricardo Titze-de-Almeida, Catherine David, Simoneide Souza Titze-de-Almeida
Ten years after Fire and Melo's Nobel Prize for discovery of gene silencing by double-stranded RNA, a remarkable progress was achieved in RNA interference (RNAi). Changes in the chemical structure of synthetic oligonucleotides make them more stable and specific, and new delivery strategies became progressively available. The attention of pharmaceutical industry rapidly turned to RNAi, as an opportunity to explore new drug targets. This review addresses nine small-interfering RNAs (siRNAs) and one unique microRNA (miRNA) inhibitor, which entered the phase 2-3 clinical trials...
April 7, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28389362/modeling-of-feed-forward-control-using-the-partial-least-squares-regression-method-in-the-tablet-compression-process
#14
Yusuke Hattori, Makoto Otsuka
In the pharmaceutical industry, the implementation of continuous manufacturing has been widely promoted in lieu of the traditional batch manufacturing approach. More specially, in recent years, the innovative concept of feed-forward control has been introduced in relation to process analytical technology. In the present study, we successfully developed a feed-forward control model for the tablet compression process by integrating data obtained from near-infrared (NIR) spectra and the physical properties of granules...
April 5, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28388235/applications-of-crispr-genome-editing-technology-in-drug-target-identification-and-validation
#15
Quinn Lu, George P Livi, Sundip Modha, Kosuke Yusa, Ricardo Macarrón, David J Dow
Structured Abstract Introduction: The analysis of pharmaceutical industry data indicates that the major reason for drug candidates failing in late stage clinical development is lack of efficacy, with a high proportion of these due to erroneous hypotheses about target to disease linkage. More than ever, there is a requirement to better understand potential new drug targets and their role in disease biology in order to reduce attrition in drug development. Genome editing technology enables precise modification of individual protein coding genes, as well as noncoding regulatory sequences, enabling the elucidation of functional effects in human disease relevant cellular systems...
April 7, 2017: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/28387961/chemical-profiling-combined-with-omics-technologies-cp-omics-a-strategy-to-understand-the-compatibility-mechanisms-and-simplify-herb-formulas-in-traditional-chinese-medicines
#16
Tengfei Xu, Zifeng Pi, Shu Liu, Fengrui Song, Zhiqiang Liu
INTRODUCTION: The compatibility mechanisms of formulas in traditional Chinese medicine (TCM) are indistinct. In order to better understand the compatibility mechanisms and the quality control of the formulas, it is necessary to simplify formulas in TCM research. OBJECTIVE: Developing a novel method by multi-analysing the contents of different compounds in formula and inferred simplified formula simultaneously. METHODOLOGY: Chemical profiling combined with "omics" technologies (CP-omics) was employed in the present study...
April 7, 2017: Phytochemical Analysis: PCA
https://www.readbyqxmd.com/read/28383083/nanoplasmonic-sensors-for-biointerfacial-science
#17
REVIEW
Joshua A Jackman, Abdul Rahim Ferhan, Nam-Joon Cho
In recent years, nanoplasmonic sensors have become widely used for the label-free detection of biomolecules across medical, biotechnology, and environmental science applications. To date, many nanoplasmonic sensing strategies have been developed with outstanding measurement capabilities, enabling detection down to the single-molecule level. One of the most promising directions has been surface-based nanoplasmonic sensors, and the potential of such technologies is still emerging. Going beyond detection, surface-based nanoplasmonic sensors open the door to enhanced, quantitative measurement capabilities across the biointerfacial sciences by taking advantage of high surface sensitivity that pairs well with the size of medically important biomacromolecules and biological particulates such as viruses and exosomes...
April 6, 2017: Chemical Society Reviews
https://www.readbyqxmd.com/read/28381721/regulatory-science-in-practice-pharmaceuticals-and-medical-devices-agency
#18
Taisuke Hojo
 Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28381718/greeting-and-general-statement-by-the-organizer
#19
Makoto Shiragami
 Regulatory science is growing increasingly important, and the Health and Medical Strategy of the Japanese government reflects this. How regulatory science is covered in pharmaceutical education is an urgent issue. Education on regulatory science is also part of the modified version of the model core curriculum in the six-year pharmaceutical course that was introduced from 2015. The Regulatory Science Task Force of the Pharmaceutical Society of Japan, in response to a commission of the Ministry of Education, Culture, Sports, Science and Technology, conducted a study on the development of teaching material and educational methods for regulatory science, held a symposium with the participation of pharmaceutical educators in February 2015, and proposed draft teaching material based on the discussions during the symposium...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28381714/status-and-problems-of-humanities-education-with-respect-to-pharmacy-education
#20
Satoko Ishikawa
 In 2006, a model core curriculum in pharmaceutical studies was developed prior to the outset of the 6-year pharmacy degree. In the 10 years that followed, medical care and life science technology has progressed, pharmaceutical laws have been revised, and the responsibilities of pharmacists have increased. In response to such social changes and needs, the Model Core Curriculum for Pharmacy Education was revised in December 2013. In order to play an active role as a pharmacist in any medical workplace, it is important for pharmacy students to develop their communication skills and attitudes in order to foster the trust of their patients and other medical professionals...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
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