Drug product administration

Approved Prescription Drug Products, with Therapeutic Equivalence Evaluations, Bureau of Dmgs, Pood and Dmg Administration, U.S. Dept, of Health and Human Services, Bethesda, Md., 1980. 

The desired speed and duration of a therapeutic effed will also influence the development of the final drug product. The standard treatment of meningitis with antibiotics is via intravenous administration so as to achieve an immediate effed. 

Drug Product Size Usual Dose Administration Monthly Cost3... 

For this calculation, it is unnecessary to assume that Vd and/or kei are the same for the two studies. It is only necessary that fe be the same in both studies. This is usually a valid assumption unless the drug undergoes a significant amount of first-pass metabolism in the gut wall or liver following oral administration or a significant amount of decomposition at an intra muscular (IM) injection site. When this occurs, the availability of the extravascular dosage form may appear to be low, but the fault will not lie with the formulation. The bioavailability will be a true reflection of the therapeutic efficacy of the drug product, and reformulation may not increase bioavailability. 

Before treating the various classes of sustained- and controlled-release drug-delivery systems in this chapter, it is appropriate to note that drug delivery may be incorporated in other chapters where the various classes of drug products and routes of administration are discussed. In addition, the reader is referred to Chapter 14 on target-oriented drug-delivery systems. 

To determine whether human testing for a new drug or new drug product is reasonable, it is first necessary to conduct preclinical studies and to submit the IND. The necessary information needed to prepare the IND is outlined in Table 1. The IND is to contain information on appropriate prior animal studies for safety evaluation, any available clinical data, adequate drug identification and manufacturing instructions, and a detailed outline of the proposed clinical study, routs of administration, approximate number of patients to be used, and an estimate of the length of treatment and an environmental impact statement. 

Most of those involved in health care administration agree that elderly patients are the primary consumers of drug products. The actual extent to which this occurs is shown quite clearly in Fig. 1, which lists by age group the distribution in the United States of the drug mentions those medications that have been prescribed, recommended or given in any medical setting... 

Parenteral administration is not perceived as a problem in the context of drugs which are administered infrequently, or as a once-off dose to a patient. However, in the case of products administered frequently/daily (e.g. insulin to diabetics), non-parenteral delivery routes would be preferred. Such routes would be more convenient, less invasive, less painful and generally would achieve better patient compliance. Alternative potential delivery routes include oral, nasal, transmucosal, transdermal or pulmonary routes. Although such routes have proven possible in the context of many drugs, routine administration of biopharmaceuticals by such means has proven to be technically challenging. Obstacles encountered include their high molecular mass, their susceptibility to enzymatic inactivation and their potential to aggregate. 

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. 

Factors directly related to the drug selection include an inappropriate selection of drug, dosage, or route of administration. Malabsorption of a drug product because of GI disease (e.g., short-bowel syndrome) or a drug interaction (e.g., complexation of fluoroquinolones with multivalent cations resulting in reduced absorption) may lead to potentially subtherapeu-tic serum concentrations. 

U.S. Food and Drug Administration. Guidance for Industry. Nonclinical Safety Evaluation of Pediatric Drug Products. 2003. 

FDA. Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (Revised) (I). Rockville MD, USA U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2003. 

Food and Drug Administration Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations, March 2003. 

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