The need for good practices in biomedical technology

The present modern technologies have made it possible for one to carry out intricate and highly sensitive procedures that in the past were impossible or unheard of. The pharmaceutical industry has provided sophisticated products with unique drug delivery systems. Instrumentation technology has made it possible for the production of machines and facilities for use in the diagnosis and management of disease. Clinical science has reached such high levels of achievement as to enable an efficient patient management. Scientists and professionals working in these fields have thus been provided with modern tools with which to provide more efficient service to mankind. But consumers having become as equally sophisticated as these advancements, also require to know whether these products, equipment and services are fail-safe. They demand assurance; as it were, quality assurance. Gone are the days when the health professional would maintain his/her absolute competence, the pharmacist would assert that the pharmaceutical product was perfect, the laboratory analyst would claim that the laboratory results were excellent, and the physician would sternly uphold his clinical supremacy. Now, it is well known that there are no such ideals in health science research and practice. To try to attain the best level possible, professional bodies all over the world have established guidelines for Quality Assurance, Accreditation and Certification. The International standards Organization (ISO) has formulated comprehensive standards for all forms of quality audit and certification. The five quality management standards of the ISO, known as ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004, have been adopted by many organizations in various countries of the world. The principles of Good Laboratory Practices (LP) which were initially formulated by the Food and Drug Administration (FDA) of the USA was adopted by the European Union (EU) in 1989. The World Health Organization (WHO) has also issued Guidelines for Good Clinical Practice (GCP), Guidelines for Good Manufacturing Practices (GMP) of Pharmaceuticals, and Guidelines for the Production of Biologicals. It is thus evident that quality assurance is a very important aspect in all fields of health science research and practice. Quality assurance embraces quality control and audit and involves three things: personnel and material resources, quality system structure, and management responsibilities. Well trained personnel are required to use the appropriate materials and tools, an efficient quality system structure is desirable, and a good management system to implement the quality assurance programme is very essential. This programme should also enable the providers of goods and services to be bold enough to disclose to the consumers when their goods and services fail, as in the recent case of Abbot Laboratories when they had to withdraw their HIV test kit from the market after failing to meet the prescribed standards. Similarly, some years ago the anti-inflammatory drug Benoxaprofen (ORAFLEX-Eli Lilly) was withdrawn shortly after its introduction in the clinic. Do the organisations in Africa have the capacity to develop, or adopt, a quality assurance programme? It is fair to answer in the affirmative Organisations in Africa can, and should, adopt any of the existing quality assurance programmes that suit their operations best. What is most important is that operations must have the means to establish specificity, accuracy, precision and sensitivity that can be verified and certified. The big question is, do all these nicely worded standards, guidelines and practices have uniform and enforceable laws that enable their effective implementation and protection of the consumers?     

A classification for biomedical research reports

Biomedical research uses a wide range of designs applied to problems in laboratory, clinical, and population settings. Whatever the nature of the study, a few key features--such as the admission rule, the method of allocating subjects to treatments, and the use of controls--largely determine the strength of scientific inferences. We used these and other features to classify the 332 Original Articles published in the New England Journal of Medicine during 1978-1979. This classification directs attention to critical aspects of study design and performance and can help in the choice of suitable research approaches and protocols. It emphasizes the critical role of the investigators' intent in performing and analyzing a study, and it alerts readers to important aspects of interpretation. We recommend that authors always report enough detail about their work for readers to apply this or a similar classification. Omission of such detail may limit the interpretation of a research study because a study that cannot be classified has probably been incompletely reported.     

The need for psychoanalysis is alive and well in community psychiatry.

While the author recognizes the positive impact community psychiatry has had on postpsychotic patients by the uses of medical management and environmental manipulation, he demonstrates that there is a deficiency in the treatment of lower socioeconomic patients with neurotic illnesses. Specifically, neurotic patients tend to be given supportive therapy and psychopharmacotherapy when a form of psychoanalytic psychotherapy would be more appropriate. The author supports these contentions by presenting three cases which have a diagnosis of hysterical neurosis and which clearly demonstrate the economic, topographical, structural, dynamic, and genetic components of the psychoanalytic theory. Finally, as psychoanalytic psychotherapy is too time-consuming, the author suggests that Freud''s early psychoanalytic technique of symptom removal by memory recovery be used when appropriate.     

生物医学工程技术在人工关节生物材料研究中的应用

生物医学工程学(biomedieal engineering,BME)是一门运用自然科学和现代工程技术的原理和方法,在多个层次上,研究各种生物体尤其是人体的结构、功能以及其它生命现象的边缘学科.     

生物医学工程技术在人工关节生物材料研究中的应用

生物医学工程学(biomedieal engineering,BME)是一门运用自然科学和现代工程技术的原理和方法,在多个层次上,研究各种生物体尤其是人体的结构、功能以及其它生命现象的边缘学科.     

双向电泳在疾病研究中的应用

生命的表现形式最终是由蛋白质决定的。因此,对蛋白质组的研究具有很现实的意义。双向电泳(2-DE)技术作为蛋白质组学研究的一项核心技术,主要用于细胞、组织以及其他样本蛋白质提取物的分析。近年来,2-DE结合质谱(MS)技术被广泛用于差异蛋白的鉴定、疾病标志物的筛选、药物靶标的确定等,目前已经成为蛋白质组学研究的支撑技术,以其高通量、高分辨率和重复性被广泛应用到各个领域,特别是生物医学的研究中。本文就近年2-DE技术的应用进展,尤其在生物医学方面的贡献做一综述。