Medicine, clinical personalized

An internal medicine clinic had been struggling with the appointment scheduling issue for a period of time. In particular, they wanted to determine the number of slots to be provided for physical exams, same-day appointments, and return appointments. The first step was to estimate the total demand for physical exams and for other appointments in the clinic. Data on average number of visits per person per year to the internal medicine clinic were available from past history. Multiplying this number by the total number of patients seen in the clinic yielded an estimate of total number of visits to be handled in the clinic. 

The manufacture of all investigational medicinal products (including placebo) that are intended for a clinical trial must be authorised and conducted according to Good Manufacturing Practice (GMP). This should be supervised and certified by a Qualified Person . An import authorisation is required for any product from outside the EU, which should also be manufactured to GMP standards. (See Ghapters 11 and 12 for information on GMP, manufacturing authorisations and Qualified Persons.)... 

Progressive multifocal leukoencephalopathy (PML) is historically a rare demyelinating disease that is usually associated with disorders of the reticuloendothelial system, neoplasias and immunosuppressive therapy [1, 2]. However, it has become more important in clinical medicine because it is frequently seen as an opportunistic secondary infection in immunocompromised persons with AIDS. PML is characterized by focal lesions that are noninflammatory and caused by infection of oligodendrocytes with the JC papovavirus. 

Vaccines Yes. Wyeth Vaccine, called VIG or vaccinia immune globulin, one dose by scarification. (Pre- and post-exposure vaccination recommended if greater than three years passed since last vaccine.) Persons who are pregnant, have clinical immunosuppression (such as persons who have undergone heart and other transplant operations and take medicines to control rejection of their new, transplanted organ), eczema, and/or leukemia/ lymphoma would be contraindicated for such vaccine. As one example, the fatality rate for immunosuppressed persons taking such vaccine could be as high as 75 percent or more. 

Most of the information sought is similar to the FDA s IND requirements. One major difference is that a Qualihed Person has to certify that the investigational medicinal product (IMP) is manufactured according to GMP The Competent Authority has the right to inspect the manufacturing facility for GMP compliance, the preclinical facility for GLP compliance, and the clinical trial sites for GCP compliance. 

Phase IV trials, like trials in Phases I-III, must be genuine investigations that are properly conducted and the data analysed. Free drug may not be given to doctors solely for them to use as they think fit. The restrictions do, however, reduce the chances for physicians to assess the new medicine personally and thus to form a roimded view of the product. The argument must therefore rest on clinical and scientific merit. 

Under section 118 of the Act, all data submitted by a company in support of an application to conduct clinical trials or market a medicinal product are confidential indeed even the existence of such an application is confidential. Breach of confidentiality attracts penalties and any person guilty of an offence under this section shall be liable (1) on summary conviction, to a fine not exceeding 400 (2) on conviction on indictment, to a fine or to imprisonment for a term not exceeding 2 years or to both. ... 

Liotta LA, Kohn EC, Petricoin EF (1914) Clinical proteomics personalized molecular medicine. JAMA 286 2211-2214... 

The range of potential applications of rhGH in clinical medicine continues to grow. The use of GH is also facilitated by the absence of any serious side effects in most instances. Although its efficacy in promoting growth in persons of short stature is beyond doubt, more convincing clinical evidence is required before its approved clinical applications are expanded further. 

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