標(biāo)題: Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen Becker Witkin Book 1998 Springer Science+Business Media New York 1998 bi [打印本頁] 作者: invoke 時間: 2025-3-21 16:54
書目名稱Clinical Evaluation of Medical Devices影響因子(影響力)
書目名稱Clinical Evaluation of Medical Devices影響因子(影響力)學(xué)科排名
書目名稱Clinical Evaluation of Medical Devices網(wǎng)絡(luò)公開度
書目名稱Clinical Evaluation of Medical Devices網(wǎng)絡(luò)公開度學(xué)科排名
書目名稱Clinical Evaluation of Medical Devices被引頻次
書目名稱Clinical Evaluation of Medical Devices被引頻次學(xué)科排名
書目名稱Clinical Evaluation of Medical Devices年度引用
書目名稱Clinical Evaluation of Medical Devices年度引用學(xué)科排名
書目名稱Clinical Evaluation of Medical Devices讀者反饋
書目名稱Clinical Evaluation of Medical Devices讀者反饋學(xué)科排名
作者: Metastasis 時間: 2025-3-21 22:05
Book 1998 and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.作者: 高原 時間: 2025-3-22 00:43
its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.978-1-61737-040-3978-1-4757-2756-2作者: gain631 時間: 2025-3-22 07:54
Injectable Collagen and a Rare Adverse Event—True Association or Artifact?cal hypersensitivity response (1–2% of treated patients). Anecdotal reports received postmarketing suggested that injection of Zyderm/Zyplast implants may be associated with an increased risk of a rare autoimmune disease, polymyositis/dermatomyositis (PM/DM). In addition, a report by Cuckier et al. 作者: 起來了 時間: 2025-3-22 11:58
Clinical Studies of Prosthetic Heart Valves Using Historical Controlse been thoughtful design and engineering, carefully controlled manufacturing specifications, thorough laboratory pulse-duplicator and wear testing, animal implantation, and limited initial clinical use with thorough and complete hemodynamic and clinical follow-up.作者: 表示向前 時間: 2025-3-22 13:46 作者: 表示向前 時間: 2025-3-22 18:47
In Vitro Diagnosticsr its sequelae. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body.”. Perhaps more simply defined, IVDs are laboratory instruments, test kits, or reagent systems.作者: 結(jié)合 時間: 2025-3-23 00:53
A Controlled Study of Intra-Articular Hyalgan? in the Treatment of Osteoarthritis of the Kneed and Drug Administration (FDA). However, this categorization may be questionable. Other regulatory authorities consider hyaluronic acid products as drugs because the mechanism of action appears to go beyond the mere physical function of replacing abnormal synovial fluid (“viscosupplementation”).作者: Brocas-Area 時間: 2025-3-23 04:08
Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves their first successful use approx 35 yr ago, both mechanical and tissue heart valve substitutes (. Fig. 1) remain imperfect, and prosthesis-associated complications have considerable impact on the long-term outlook for persons who have had valve replacement surgery.作者: Phagocytes 時間: 2025-3-23 08:10
Polyurethane Pacemaker Leadsperformance of marketed products may be misleading if not done appropriately. Clinically based postmarket surveillance can reveal the true actuarial survival of a device and the clinical mode of failure. Analysis of returned products may be required to understand the details of failure mechanisms ..作者: 痛恨 時間: 2025-3-23 12:20 作者: insolence 時間: 2025-3-23 16:18
Hideo Tanaka,Kazutomi Sugihara,Yutaka Maedae been thoughtful design and engineering, carefully controlled manufacturing specifications, thorough laboratory pulse-duplicator and wear testing, animal implantation, and limited initial clinical use with thorough and complete hemodynamic and clinical follow-up.作者: 圓柱 時間: 2025-3-23 19:27
Studies in Fuzziness and Soft Computinge lengthy history and, as such, has been frequently—and at times inappropriately—used as a template for establishing standards for the conduct of orthopedic research. Both, however, share certain basic elements that are central to realizing good clinical research.作者: Coterminous 時間: 2025-3-24 01:53 作者: 肉體 時間: 2025-3-24 04:22
Categorical Innovations for Rough Setsd and Drug Administration (FDA). However, this categorization may be questionable. Other regulatory authorities consider hyaluronic acid products as drugs because the mechanism of action appears to go beyond the mere physical function of replacing abnormal synovial fluid (“viscosupplementation”).作者: 變形詞 時間: 2025-3-24 10:02 作者: Germinate 時間: 2025-3-24 14:27
Hongyuan Shen,Shuren Yang,Jianxun Liuperformance of marketed products may be misleading if not done appropriately. Clinically based postmarket surveillance can reveal the true actuarial survival of a device and the clinical mode of failure. Analysis of returned products may be required to understand the details of failure mechanisms ..作者: chronicle 時間: 2025-3-24 15:13
device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan- dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials cond作者: 的染料 時間: 2025-3-24 22:19
Rough Set Methods and Applicationsed effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally tens of thousands of different types of health-care products, including in vitro diagnostics.作者: conjunctiva 時間: 2025-3-25 02:01
Jerzy W. Grzymala-Busse,Rachel L. Freeman chapter will provide information on FDA regulatory requirements for controlled clinical investigations of medical devices and diagnostics, including who must conduct a clinical trial, the submissions required, and the procedures that must be followed.作者: Brain-Waves 時間: 2025-3-25 03:32
Clinical Trials in Development and Marketing of Medical Devicesed effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally tens of thousands of different types of health-care products, including in vitro diagnostics.作者: Harbor 時間: 2025-3-25 11:03
Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics chapter will provide information on FDA regulatory requirements for controlled clinical investigations of medical devices and diagnostics, including who must conduct a clinical trial, the submissions required, and the procedures that must be followed.作者: surrogate 時間: 2025-3-25 15:12 作者: 無情 時間: 2025-3-25 16:06 作者: Alveoli 時間: 2025-3-25 20:11
Lech Polkowski,Shusaku Tsumoto,Tsau Y. Line because of cost or practical limitations (e.g., a rare disease), or unethical as in circumstances where no alternative therapy exists. Occasionally, nonrandomized concurrent controlled trials or even observational studies based on sound historical data may be considered valid alternatives in the evaluation of devices..作者: 流浪者 時間: 2025-3-26 02:21
Rough Set Methods and Applicationsstics (independent variables), and well-defined objective outcome measures (dependent variables or endpoints). Outcome measures, then, are a key component in the materials that the FDA uses to review and assess the safety and effectiveness of new devices.作者: 發(fā)炎 時間: 2025-3-26 06:50
Observational Researche because of cost or practical limitations (e.g., a rare disease), or unethical as in circumstances where no alternative therapy exists. Occasionally, nonrandomized concurrent controlled trials or even observational studies based on sound historical data may be considered valid alternatives in the evaluation of devices..作者: 代理人 時間: 2025-3-26 11:02 作者: mighty 時間: 2025-3-26 13:21
Clinical Trials in Development and Marketing of Medical Devices action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally te作者: 河潭 時間: 2025-3-26 20:51 作者: BINGE 時間: 2025-3-26 23:12
Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devicesrs with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness.. Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clin作者: Proclaim 時間: 2025-3-27 01:38 作者: 車床 時間: 2025-3-27 09:10 作者: exercise 時間: 2025-3-27 11:08
Prospective Multicenter Clinical Trials in Orthopedicsorthopedics date back over 30 yr and the 1976 Medical Device Amendments of the Food, Drug, and Cosmetic Act are commemorating 20 yr, it has been scarcely more than a decade that orthopedic clinical studies have been conducted with any degree of consistency. Pharmaceutical clinical research has a mor作者: podiatrist 時間: 2025-3-27 16:17
Long-Term Evaluation of Total Hip Arthroplastyplant can almost always be guaranteed substantial pain relief, greatly improved range of motion, and an improved quality of life. Unfortunately, many patients will, over time, experience a subsequent loosening of their prosthesis and a return of the clinical symptoms that led to the original arthrop作者: exclamation 時間: 2025-3-27 18:49
Injectable Collagen and a Rare Adverse Event—True Association or Artifact? long history of safe and effective use.. Zyderm? and Zyplast? implants are forms of injectable bovine collagen (highly purified bovine dermal collagen, containing at least 95% Type I and < 5% Type III collagen in a fibrillar suspension of physiologic buffered saline and 0.3% lidocaine). Injectable 作者: 官僚統(tǒng)治 時間: 2025-3-27 23:38 作者: Accommodation 時間: 2025-3-28 04:11
A Controlled Study of Intra-Articular Hyalgan? in the Treatment of Osteoarthritis of the Kneeified hyaluronic acid (500–730 kDa), prepared as a buffered solution in physiologic saline. Hyalgan is injected intra-articularly for the sustained relief of pain and joint dysfunction in osteoarthritis of the knee. This product is classified as a device according to the current ruling of the US Foo作者: contrast-medium 時間: 2025-3-28 08:55
Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valvesisease, and improves the survival and enhances the quality of life of many individuals.. Nevertheless, problems associated with prostheses remain a major impediment to the long-term success of this procedure. Despite considerable improvement in the technology of heart valve replacement devices since作者: 一加就噴出 時間: 2025-3-28 11:02
Polyurethane Pacemaker Leadsay not be able to detect low-level or long-term complications. No matter how much premarket work one does and no matter how sophisticated the protocols, the only valid proof of long-term reliability is performance in the field; that is, through postmarket surveillance. Even studies on the long-term 作者: harangue 時間: 2025-3-28 17:26
Rough Set Methods and Applications action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally te作者: GIBE 時間: 2025-3-28 22:28
Lech Polkowski,Shusaku Tsumoto,Tsau Y. Liny and effectiveness, and constitutes the basis of the approval process for many medical devices.. One of the most important reasons why this method is preferred is that, through the randomization process, it is more likely to lead to an unbiased interpretation of results than other types of study de作者: 繼承人 時間: 2025-3-29 01:24
Rough Set Methods and Applicationsrs with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness.. Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clin作者: Nmda-Receptor 時間: 2025-3-29 03:33 作者: 鉤針織物 時間: 2025-3-29 08:47
Hideo Tanaka,Kazutomi Sugihara,Yutaka Maeda with the natural history of heart valve disease. Experience has proven that acceptable replacement devices for diseased heart valves can be produced and evaluated clinically in single-arm studies, without using randomized or other concurrent controls. The elements of this successful development hav作者: Charitable 時間: 2025-3-29 14:54 作者: Factual 時間: 2025-3-29 19:38
https://doi.org/10.1007/978-3-540-89921-1plant can almost always be guaranteed substantial pain relief, greatly improved range of motion, and an improved quality of life. Unfortunately, many patients will, over time, experience a subsequent loosening of their prosthesis and a return of the clinical symptoms that led to the original arthrop作者: 襲擊 時間: 2025-3-29 22:30
P. Eklund,M. A. Galán,J. Karlsson long history of safe and effective use.. Zyderm? and Zyplast? implants are forms of injectable bovine collagen (highly purified bovine dermal collagen, containing at least 95% Type I and < 5% Type III collagen in a fibrillar suspension of physiologic buffered saline and 0.3% lidocaine). Injectable 作者: 使饑餓 時間: 2025-3-30 01:09
Rajen Bhatt,Sheela Ramanna,James F. Petersc Devices (IVDs). IVDs are, by definition of the Food and Drug Administration (FDA), “...those reagents, instruments and systems intended for use in the diagnosis of disease, or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease o作者: 漸變 時間: 2025-3-30 04:37
Categorical Innovations for Rough Setsified hyaluronic acid (500–730 kDa), prepared as a buffered solution in physiologic saline. Hyalgan is injected intra-articularly for the sustained relief of pain and joint dysfunction in osteoarthritis of the knee. This product is classified as a device according to the current ruling of the US Foo作者: 工作 時間: 2025-3-30 10:05 作者: 可能性 時間: 2025-3-30 12:51 作者: Axillary 時間: 2025-3-30 19:26
https://doi.org/10.1007/978-1-4757-2756-2biodegradation; control; data analysis; design; development; diagnostics; hip arthroplasty; information; mar作者: Hdl348 時間: 2025-3-30 23:48
978-1-61737-040-3Springer Science+Business Media New York 1998
