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24 applications found
TrueVue ODM+ enables clinicians to guide fluid and drug administration during major and high-risk surgery. When used to guide perioperative fluid management, ODM is proven to reduce postoperative ...
ByDeltex Medical Limited based in Chichester, UNITED KINGDOM
More recently, PAT has become a cornerstone of the US Food and Drug Administration’s (US FDA) Quality by Design (QbD) initiative for both the design and control of quality processes. ...
ByMettler - Toledo Int. Inc based in Greifensee, SWITZERLAND
Concurrent with the U.S. Food and Drug Administration’s final rule establishing regulations to require current good manufacturing practices (cGMPs) for dietary supplements, PTL can offer cGMP services to all supplement manufacturers. ...
ByParticle Technology Labs based in Downers Grove, ILLINOIS (USA)
This information is submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and Health Canada, to enable approval for patient use. ...
ByZymeworks Inc based in Vancouver, BRITISH COLUMBIA (CANADA)
Finch’s lead candidate, CP101, is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI), and has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration. In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. ...
ByFinch Therapeutics Group, Inc. based in Somerville, MASSACHUSETTS (USA)
In Dairy Industry applications, 'polishing' of these process water streams aids in the production of Class I water for re-use from dairy products as defined and regulated under Food & Drug Administration rules. Water produced with this technique is also very soft, generally resulting in lower cleaning chemical ...
ByGEA based in Hudson, WISCONSIN (USA)
However, in late May, 2013, the spot check by Guangdong Food and Drug Administration has just found there were 120 batches of cadmium-out-of-limits rice, which came from 8 cities in Hunan provinces. ...
ByPreeKem Scientific Instruments Co.,Ltd. based in Shanghai, CHINA
The pharmaceutical industry is one of the most regulated industries. Contaminants in drug products are examined throughout the manufacturing process, since their presence affects drug stability, behaviour and toxicity. Therefore, regulatory bodies such as the European Medicines Agency (EMEA) and the American Food and Drug Administration (FDA) strictly enforce continuous and ongoing analysis of organic or inorganic impurities from raw materials, ...
ByXenemetrix Ltd. based in Migdal Haemek, ISRAEL
Clinical trials are scientific studies, conducted by doctors, to determine how well a new treatment works and if it has any side e?ects in people. The goal is to help people by finding better ways to prevent, screen for, diagnose, or treat disease. People can participate in clinical trials as patients or healthy ...
ByZymeworks Inc based in Vancouver, BRITISH COLUMBIA (CANADA)
One of the biggest challenges in clinical trials is recruiting volunteers. Often, the challenge lies in the ability to educate patients. Understanding the potential benefits and risks of participating in a clinical trial can be overwhelming. As a healthcare provider, you can help patients navigate the pros and cons and the questions they may have about clinical trials. With your help, patients can better decide what is the best course for their individual ...
ByCellphire Therapeutics, Inc. based in Rockville, MARYLAND (USA)
Since its inception, Yukon Medical has worked directly with clinicians and users to understand their needs and build products that keep them safe and address the complex challenges associated with current devices. The feedback and input of healthcare workers continues to be at the center of everything we do to inform our iterative, human-centered design process, resulting in products built with clinician needs and patient well-being in ...
ByYukon Medical, LLC based in Durham,, NORTH CAROLINA (USA)
The pinnacle of scientific evidence is the Level I study. i-FACTOR Bone Graft is one of a small group of bone grafting technologies that is supported by Level I evidence. i-FACTOR Bone Graft was evaluated in a 319-patient, prospective, randomized, controlled, multi-center clinical trial assessing its safety and efficacy compared to standard-of-care (autograft). Patients underwent anterior cervical discectomy and fusion (ACDF) and received either i-FACTOR Bone Graft or local autograft in a cortical allograft ring ...
ByCerapedics, Inc. based in Westminster, COLORADO (USA)
Whether TOC or VOC, Teledyne Tekmar has the best instruments for your pharmaceutical water-quality testing needs. Introduction of organic matter into water systems occurs not only from living organisms and from decaying matter in source water, but from purification and distribution system materials. A relationship may exist between endotoxins, microbial growth, and the development of biofilms on pipeline walls and biofilm growth within pharmaceutical distribution systems. A correlation is believed to exist between ...
ByTeledyne Tekmar based in Mason, OHIO (USA)
GI Dynamics has taken all necessary COVID-19 precautions to ensure patient safety, which remains top priority. Patient screening for the STEP-1 pivotal trial of EndoBarrier has reopened at select sites and enrollment will be conducted according to site requirements and CDC/FDA ...
ByGI Dynamics, Inc. based in Boston, MASSACHUSETTS (USA)
When it comes to pharmaceutical, nutraceutical, and chemical manufacturing, there is not only a high degree of regulation on the process, but an industry responsibility to supply the purest products for consumption and wear. At Filter Sciences, we create high-quality bag filter housings that exceed industry standards so that you can manufacture the best ...
ByFilter Sciences based in Fort Wayne, ALABAMA (USA)
Regulatory bodies such as the United States Food and Drink Administration and the European Union have regulations related to the use of chemicals in food packaging materials. This application note details how the HT3 Automated Headspace Analysers can be ...
BySCION Instruments BV - Techcomp Group based in GP Goes, NETHERLANDS
On-line Monitoring of Bioprocesses. PTR-MS systems can be used to gather highly relevant process related information in biopharmaceutical fermentations from analyzing volatile metabolites in the fermenters ...
ByIonicon Analytik Ges.m.b.H. based in Innsbruck, AUSTRIA
Trojan Technologies has the largest installed base of applications in the Life Sciences industry, meeting the demands of USP and WFI applications. UV Technology in Life Sciences. For over 70 years, Aquafine UV systems have been successfully serving the diverse Life Sciences industry. Aquafine UV systems are reliable, deliver consistent performance, and have become the brand of choice of WFI (Water-For-Injection) & USP (United States Pharmacopoeia) systems. Aquafine systems are found in both the pre-treatment ...
ByAquafine - a brand by Trojan Technologies based in Valencia, CALIFORNIA (USA)
IONICON PTR-MS systems can analyze trace gas concentrations of volatile metabolites in the off-gas of bio-pharmaceutical fermentations in real-time. This highly relevant process related information can be used for on-line process monitoring and process ...
ByIonicon Analytik Ges.m.b.H. based in Innsbruck, AUSTRIA
Microbe Inotech Laboratories, Inc. provides a microbial genomics platform through licensed database agreements focused on the characterization of microorganisms, pathogens and anti-microbial resistance for pathogen detection, food safety inspections and issues, pharmaceutical discovery, public health surveillance, water and wastewater analysis, agriculture and microbiome analysis and comparisons. From a post-sequencingmetagenomic sample (i.e. DNA extracted from your sample) the MiL Inc. provides identification ...
ByPluton Biosciences, Inc. based in St. Louis, MISSOURI (USA)