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Health Professionals and Modern Human Research Ethics
Published in Howard Winet, Ethics for Bioengineering Scientists, 2021
Research articles reporting results of clinical trials became a boon to the physician in the field. She now had actual data on which to base her treatment decisions. But the number of alternatives and the rate at which they were appearing threatened to overwhelm those practitioners who were not trained in science. Recognizing physicians’ need for drug information, and realizing the advantages of presenting it in one publication, the pharmaceutical industry in 1946 began to publish an annual drug reference (now online) that summarizes all the information included in each drug package’s insert. This Physicians’ Desk Reference (PDR) carries the implied approval of the Food and Drug Administration (FDA) that must approve the insert’s content. Drug effectiveness is represented by “indications”, conclusions about what symptoms might prompt use of the drug in question. In this source the newly minted physician will find the drug she learned as the standard of care. The PDR may still list the drug, but it may no longer be the standard of care, because it may have been replaced, based on further epidemiological studies that have found a drug more effective, in the judgment of the specialists who use it. These specialists will report new study results in medical journals and at meetings of their societies. By going to these meetings physicians learn the latest details about new drugs, often before results are published.
Translating Sensor Technology into the Medical Device Environment
Published in Kevin Yallup, Krzysztof Iniewski, Technologies for Smart Sensors and Sensor Fusion, 2017
When speaking of regulatory control of medical devices, one must first define both the intended use and indication for use. Though similar, the concepts differ and the latter is in some sense a subset of the former. Intended use refers to the overall goal in using the device and can be fairly generic (21 CFR 801.4). The indication(s) for use (e.g., 21 CFR 814.20(b)(3)(i)) refers to “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended.” Therefore, a given device can in principle have many indications for use, and each new use must be evaluated in terms of whether it creates new questions of safety and efficacy, and if so, the device maker will need to provide data establishing safety and efficacy (possibly clinical data). Developers of medical sensors, therefore, must navigate this preliminary classification question and delineate clearly the role of the sensor and how it will affect patient health.
Introduction to Biotechnology Operations: Planning for Success
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
The focal point of a biotechnology operation is the product, and at the heart of product development are the user and intended use. The operational team of professionals works together to add value, bring the product to market, and ultimately to the end user. Hence, a key to building a successful biotechnology operation is to maintain this focus on product and its intended use and the user. In biopharmaceutical development, the intended use is the product indication, a word that will be used repeatedly in this book. In medicine, an indication is defined as the reason a product is used to diagnose, prevent, or treat a specific disease or condition. An indication also identifies, to a great extent, the intended user of a biotechnology product. This is especially true for biopharmaceuticals. In addition to having an indication, biotechnology development is also based on an understanding of the molecular or cellular nature of a product and on the product’s safety, strength, purity, and potency.
Stress distribution of three-unit fixed partial prostheses (conventional and pontic) supported by three or two implants: 3D finite element analysis of ductile materials
Published in Computer Methods in Biomechanics and Biomedical Engineering, 2019
Marcelo Bighetti Toniollo, Ligia Jaqueline Pereira Vieira, Mikaelly dos Santos Sá, Ana Paula Macedo, Jair Pereira de Melo, Andrea Sayuri Silveira Dias Terada
The rehabilitation of posterior edentulous mandibular areas is difficult to perform and of fundamental importance to patients. Therefore, it is important to validate studies that clarify doubts regarding the operation of the system in these regions. As stated, there are cases of anatomical, biological, and even financial limitations that make it impossible to use the ideal number of implants. In such cases, it is essential to be knowledgeable and safe in the indication or contraindication of alternative treatments (Buser et al. 1998; Taylor et al. 2000; Silva et al. 2005).
Regulatory considerations in biosimilars: Latin America region
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
The basis of the therapeutic indications depends on the data obtained from nonclinical and clinical studies. A proper justification has to be provided for the biosimilar to be approved for use on other clinical indications if the biosimilar has to be approved for an indication for which the RP is not approved.[7]