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Product Development in Biotechnology
Published in Firdos Alam Khan, Biotechnology Fundamentals, 2020
Once a drug has completed preclinical trials with a great success rate, the drug molecule is now ready for testing in humans, starting with normal and healthy individuals, to check the toxicity or side effects of the drug molecule. If the drug does not show any apparent toxicity or side effects, it may now be tested in patients suffering from specific disease conditions. There are four phases of clinical trials: Phase I, Phase II, Phase III, and Phase IV. All these phases are conducted in specialized and FDA-approved clinical centers and hospitals. In healthcare, clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety. Health authority or ethics committee approval is granted in the country where the trial is taking place. Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients in small pilot studies initially, followed by larger-scale studies in patients that often compare the new product with the currently prescribed treatment. As positive safety and efficacy data are gathered, the number of patients is typically increased. Clinical trials can vary in size from a single center in one country to multicenter trials in multiple countries.
Preliminaries
Published in Dev P. Chakraborty, Observer Performance Methods for Diagnostic Imaging, 2017
The methods described in this book need to be placed in context of a six-level hierarchy of assessment methods.7,59 The cited paper by Fryback and Thornbury titled “The efficacy of diagnostic imaging” is a highly readable account, which also gives a more complete overview of this field, including key contributions by Yerushalmy60 and Lusted.61 The term efficacy is defined generically as the probability of benefit to individuals in a defined population from a medical technology applied for a given medical problem under ideal conditions of use. Demonstration of efficacy at each lower level is a necessary but not sufficient condition to assure efficacy at higher level. The different assessment methods are, in increasing order of efficacy:* technical, diagnostic accuracy, diagnostic thinking, therapeutic, patient outcome, and societal, Table 1.1.
Cervical Dysplasia Diagnosis with Fluorescence Spectroscopy
Published in Mary-Ann Mycek, Brian W. Pogue, Handbook of Biomedical Fluorescence, 2003
Rebecca Richards-Kortum, Rebekah Drezek, Karen Basen-Engquist, Scott B. Cantor, Urs Utzinger, Carrie Brookner, Michele Follen
Both emerging and existing technologies should be based on biological plausibility and proven to be effective. Efficacy should be studied in homogeneous populations by using standardized procedures under ideal testing conditions by expert practitioners. Existing technologies can be studied for effectiveness. Effectiveness is the measure of efficacy under conditions of routine clinical care by ordinary practitioners in heterogeneous populations. Efficacy is typically assessed in clinical trials. Effectiveness is the evaluation of technology in the “real world” or “community.” Both emerging and existing technologies should also be assessed for safety, reproducibility, patient satisfaction, and cost-effectiveness.
inHEART Models software – novel 3D cardiac modeling solution
Published in Expert Review of Medical Devices, 2023
Leah A. John, Brett Tomashitis, Zain Gowani, Dan Levin, Chau Vo, Ian John, Jeffrey R. Winterfield
Cardiovascular disease is a leading cause of mortality worldwide, accounting for approximately 30% of all deaths globally. Roughly half of all cardiovascular deaths are due to sudden cardiac death (SCD), and 80% of these deaths result from ventricular arrhythmias (VA) [1,2]. VA often occurs in patients with structural heart disease, including those with ischemic (ICM) and/or non-ischemic cardiomyopathy (NICM), or in those with genetic predispositions. Clinical presentation can vary from syncope, electrical storm, cardiogenic shock, cardiac arrest, and SCD [1]. Treatment strategies for prevention of SCD and reduction of VA risk include implantation of implantable-cardioverter defibrillators (ICDs), anti-arrhythmic drug therapy, and radiofrequency catheter ablation (RFCA) for ventricular tachycardia (VT). These therapies, however, are not without inherent risks including adverse drug effects, procedural risks, and inadequate efficacy [3]. Efforts aimed at improving the efficacy of such therapies are essential in optimizing patient safety and treatment success. In those requiring RFCA, advanced cardiac imaging is becoming an increasingly integral component in pre-procedural planning to guide ablation strategy.
RSM-BBD optimization approach for degradation and electrochemical sensing of Evan’s blue dye using green synthesized ZrO2–ZnO nanocomposite
Published in Inorganic and Nano-Metal Chemistry, 2023
A. Ananda, T. Ramakrishnappa, T. N. Ravishankar, L. S. Reddy Yadav, B. K. Jayanna
In the current work, the solution combustion process reported the synthesis of ZrO2-ZnO NPs with a hexagonal wurtzite structure using Zirconium (IV) oxynitrate hydrate and Zinc nitrate as the metal precursor and an oxidizer, Basella alba raw juice at a varying concentration as natural fuel at 600 °C. At a fixed dye concentration and catalytic load, a series of photocatalytic tests were carried out at identical experimental conditions. ZrZn4 has a high degradation capability, and it degraded 100% of the dye in 90 min. It is because ZrZn4 porosity and surface area were slightly higher compared to the other three NPs, which gives a comparatively more active site for faster degradation. By taking three center points, 15 experimental trials were created utilizing the Box-Behnken model-RSM. Under the constraints, the best conditions for EB elimination are 1.25 mg/L dye concentration at pH 12.0 and a contact time of 60 min, with a 99% response. There is no significant difference between the linear and non-linear relationships between experimental and predicted degradation percentages. To further justify its use, the efficacy of these approaches is statistically assessed using well-established statistical criteria. According to electrochemical sensing investigations, ZrZn4 could be employed as an EB electrochemical sensor.
The Problem with Luminous Efficacy
Published in LEUKOS, 2020
A rate is a ratio of unlike quantities, such as miles/hour, beats/minute, and points/game. Efficacy is a special type of ratio that represents a rate of consumption, such as miles/gallon and gallons/flush, where one side of the fraction represents a benefit and the other a cost. With miles/gallon, the benefit is miles driven and the cost is gallons of fuel consumed. With gallons/flush, the benefit is the removal of waste by the flush and the cost is gallons of water consumed. Efficacy is intended to be a measure of the ability of something to do what it is supposed to do.