Medical well-established

Computerized Tomographic Imaging (CT), a well established method in medical diagnostics for 25 years now, also makes its arrival into non-destructive testing since the last decade. 

The EU will accept applications without supporting pre-clinical and clinical data, if it can be demonstrated that the active substances have been in well-established medical use in the Community for at least 10 years, with recognised efficacy and an acceptable level of safety. This route would be appropriate for many common over-the-counter (OTC) products. Safety and efficacy is supported by providing copies of published scientific literature as part of the submission that is, the submission relies on safety and efficacy data available in the public domain, as opposed to confidential data from authorised applications that is the cornerstone of generic applications. 

The approach is quite similar to that for a well-established medical product, in that the applicant must submit bibliographic data supporting the safety, efficacy and duration of the traditional use of the herbal remedy (see Table 8.2). 

NMR microscopy has become a well-established method in many different areas of research. The scope of the disciplines involved is extremely broad and is still expanding, encompassing chemical, petrochemical, biological and medical research, plant physiology, aerospace engineering, process engineering, industrial food processing, materials and polymer sciences. 

Dozens of clinical trials plus decades of clinical practice plus millions of content patients can t be that wrong. Whatever the bias in whatever the study, common sense clearly says the sum of the parts attesting antidepressants efficacy blatantly outnumbers the evidence showing the opposite. The use of these antidepressants is now deeply rooted and well-established in medical society worldwide, it s safe, it works, and there s no shadow of doubt about it.2... 

There are many excellent texts on nutrition. This chapter, therefore, focuses not on nutrition per se but on how biochemistry helps us understand well established and less well established aspects of nutrition and how such knowledge fits in with other subjects discussed in this text. There is now considerable medical and lay interest in what is meant by healthy and unhealthy diets. Nutrition has become a major issue in the medical sciences and in clinical practice. It is also of concern to politicians, particularly in the link between nutrition and Western diseases such as cardiovascular disease, obesity, cancer and neurological problems. In this chapter an attempt is made to provide a biochemical basis for discussion of nutrition and development of these conditions. To this end, biochemical explanations for nutritional advice and the recommendations from national bodies are provided. Similarly, explanations for the recommendations designed for different populations, different conditions and activities (physical and mental activity, the elderly, the young, during pregnancy and space flight) are discussed. Finally, the biochemistry of malnutrition, undemutrition and ovemutrition is discussed. 

This decision probably seems to have had more of a political impact than a legal one. It has energized medical marijuana advocates as well as supporters of jury nullification—the idea that jurors should be able to decide whether a law is being fairly applied in a particular situation. Barring the acknowledgement of a medical necessity defense, the well-established principle that federal laws take precedence when in conflict with state laws means that the medical marijuana dispute would have to be ultimately resolved on the national level. 

A principal interest in our laboratory is the molecular characterization of CNS receptor sites of the neurotransmitter dopamine (DA, 5). These sites are strongly implicated in the biochemical etiology of schizophrenia and Parkinson s Disease, as well as other diseases of the CNS (50,51). Thus, the rank order of clinical potency of antipsychotic drugs (neuroleptics) correlates with the affinity of these drugs for dopaminergic sites (52,53), It is also well established that Parkinson s disease is directly related to deterioration in dopaminergic neurotransmission in the corpus striatum, which is a brain region rich in dopamine receptor sites (54). The use of L-DOPA, the biosynthetic precursor of dopamine, in treatment of patients with Parkinson s disease is one of the best examples of biochemically directed medical treatment. 

Opium is made by drying the liquid that comes from the unripe seed capsule of the opium poppy, a flowering plant common to certain parts of the world. References to opium and its medicinal value have been found in writings dating from several thousand years ago. Up until the twentieth century, opium was prized for its ability to alleviate pain, treat diarrhea, and elevate mood. In addition to its well-established use as a treatment for pain and diarrhea, opium was touted and used as a cure for a wide range of other medical problems. In truth,... 

Medical applications of membranes Artificial kidneys Artificial lungs Controlled drug delivery Well-established processes. Still the focus of research to improve performance, for example, improving biocompatibility... 

The submission of an application conveys an acceptance of certain responsibilities, including the accuracy and the quality of the data as well as the required subsequent reporting and technical commitments for the product and its intended use. To assure the accuracy and quality of the data and information provided in applications, the Act gives the FDA broad authority to inspect pharmaceutical and medical device establishments, including manufacturers and other research testing facilities from which data are derived. Applicants therefore must have documented systems in place for all processes from which data are derived and included... 

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