Safety and benefit

Therapeutic Measure of a drug s benefit and safety. A Wide index -... 

Denke MA. Hormone replacement therapy benefit and safety issues. Curr Opin Lipidol 1996 7(6) 369-73. 

Treatment of human immunodeficiency virus (HIV) infections has been radically modified during the past two years by the introduction of powerful antiretroviral drugs, and by the development of methods to determine the viral burden in plasma. The introduction of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors has made this breakthrough possible. However, the long-term therapeutic benefits and safety profiles of these agents are still being evaluated. 

Arthur P, Bahl P, Bhan MK, Kirkwood BR, Martines J, Moulton LH, Panny ME, Ram M, Ram M, Underwood B. Randomised trial to assess benefits and safety of vitamin A supplementation linked to immunisation in early infancy. WHO/CHD Immunisation-Linked Vitamin A Supplementation Study Group. Lancet 1998 352(9136) 1257-63. 

The benefits and safety of parenteral nutrition have been considerably improved in recent years by innovative strategies, such as supplementation with medium-chain triglycerides, glutamine, or branch-chain amino acids. 

Large comparative study (compound versus placebo) in patients to establish clinical benefit and safety. Drug Launch and subsequent safety surveillance. 

As mentioned previously, since virtually all models of safety determination are based on empirical evidence, only minor variations of the basic models seen in the FDA food safety determination system are possible. These differences are based more upon emphasis and implementation than on any profound differences in methodology. One major exception to this uniformity is the food safety model based upon the reasonable certainty of no harm concept. As opposed to other models where benefits from the addition of the new ingredient need to be demonstrated, in that model safety is seen as no harm and no proof of beneficial effects is needed. As discussed further in Chapter 4, the committee believes that for infant formulas, the concepts of efficacy (benefit) and safety are not always mutually exclusive because of the uniqueness of the infant population and, therefore, potential benefit should be considered when allowing new ingredients to be added to infant formulas. 

Carlson 8K etal. (2001) Benefits and safety of CT fluoroscopy in interventional radiologic procedures. Radiology 219 515-520... 

The regulatory authorities are conducting an evaluation and assessment based on submitted comprehensive quality, non-clinical and clinical documentation aiming to demonstrate the benefit and safety for the patient. The authority evaluation includes the entire finished product, i.e. active substance, excipients and container closure system (cylinder and valves). 

Barham, P., Alexander, A., and Oxley, P. 1994. What are the benefits and safety implications of route guidance systems for elderly drivers. Paper presented at the Seventh International Conference on Road Traffic Monitoring and Control, London. 

Kardinaal, A.F.M., Waalkens-Berendsen, D.H., and Arts, C.J.M., Pseudo-oestrogens in the diet Health benefits and safety concerns. Trends Food Sci. Technol., 8, 327-333, 1997. 

Persons who have conditions associated with decreased immunological function that increase the risk for severe pneumococcal disease or its complications should be vaccinated. Although the vaccine is not as effective for immunocompromised patients as it is for immunocompetent persons, the potential benefits and safety of the vaccine justify its use. 

Harmon KE, Ryan JA Jr, Biehl TR, et al (1999) Benefits and safety of hepatic resection for colorectal metastases. Am J Surg 177 402-404... 

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