Drug administration costs

The importance of the penicillins as a class of heterocyclic compounds derives primarily from their effectiveness in the treatment of bacterial infections in mammals (especially humans). It has been estimated that, in 1980, the worldwide production of antibiotics was 25 000 tons and, of this, approximately 17 000 tons were penicillins (81MI51103). The Food and Drug Administration has estimated that, in 1979 in the U.S.A., 30.1 x 10 prescriptions of penicillin V and 44.3 x 10 prescriptions of ampicillin/amoxicillin were dispensed. This level of usage indicates that, compared to other methods of dealing with bacterial infection, the cost-benefit properties of penicillin therapy are particularly favorable. Stated differently, penicillin treatment leads to the elimination of the pathogen in a relatively high percentage of cases of bacterial infection at a relatively low cost to the patient in terms of toxic reactions and financial resources. 

These products may be beneficial for OA of the knee that is unresponsive to other therapy, but they are expensive because treatment includes both drug and administration costs. 

U.S. Food and Drug Administration. Medwatch. www.jda.gov/medwaich/safety.htm Veenstra, D.L., et al., "Assessing the Cost-Effectiveness of Pharmacogenomics," AAPS PharmSci., 2 (3), 1-11 (2000) article 29 (http /www.pharmsci.org)... 

Successful vaccines have several important properties such as safety, effectiveness, low cost per dose, and ease of preparation. Vaccines, whether peptide, protein, or DNA, have limited potency without codelivery with an adjuvant and/or a specialized delivery system (11). There is currently a lack of safe, nontoxic, effective. Food and Drug Administration (FDA)-approved vaccine adjuvants capable of stimulating cellular (Thl) immunity (12). Most potent immune activators are also toxic at relatively low doses and cannot, therefore, be successfully used as adjuvants (12). 

Polyacetals and other engineering plastics cost about half that of cast metals, and are therefore used as replacements for cast metal-intense applications. They have been approved by the Food and Drug Administration for contact with foods. Some of the uses of molded polyacetals are as valves, faucets, bearings, appliance parts, springs, automotive window brackets, hose clamps, hinges, video cassettes, tea kettles, chains, flush toilet float arms, gears, shower heads, pipe fittings, pasta machines, desktop staplers, and air gun parts. 

While "natural" is the current catch-phrase of today s consumer, research must still be performed for the development of synthetic compounds that can lower the cost of production of food that can be utilized to develop other less costly food items. Amino acids or proteins with O-aminoacyl sugars as part of their residue have been examined for their taste impact Chapter 12). Several of these components have been shown to be potential replacements for salt (NaCl) this would have a significant impact for individuals with high blood pressure or with a propensity to other coronary or renal problems. Some glycosides, represented by some sucrose esters, are approved by the United States Food and Drug Administration for food use. These glycosides have potential use in the preparation of food materials and can lead to more cost effective means of production Chapter 18). 

The final two sections discuss the Food and Drug Administration (FDA) regulatory process and the cost of treatment. Expenses associated with assessment and treatment and, more importantly, the total economic impact on patients, their families, and society are considered. 

The time and expense required to develop new drug products are enormous. A recent public food and drug administration (FDA) report (1) estimates that the cost of bringing a new drug to market is between 800 million to 1.7 billion, which represents a 50% increase in just five years (Fig. 1). This cost escalation has very substantial consequences The number of new drugs and devices submitted to the FDA is dropping rapidly and today it is less than half the number submitted five years ago (Fig. 2). Because of these rising... 

This important antifungal drug (see Chapter 48) is an alternative therapy for visceral leishmaniasis, especially in parts of India with high-level resistance to sodium stibogluconate. Liposomal amphotericin has shown excellent efficacy at a dosage of 3 mg/kg/d intravenously on days 1-5, 14, and 21. Nonliposomal amphotericin (1 mg/kg intravenously every other day for 30 days) is much less expensive, also efficacious, and widely used in India. Amphotericin is also used for cutaneous leishmaniasis in some areas. The use of amphotericin, and especially liposomal preparations, is limited in developing countries by difficulty of administration, cost, and toxicity. 

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