Administrative utility

When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. 

The most important requirement is that the salt possesses sufficient solubility at physiologically compatible pH values to permit incorporation into the dosage form. Buffering the solution to an appropriate pH can often enhance solubility. Salts may also be prepared in situ in the formulation. This is particularly useful when the main route of administration utilizes the parent drug form. Where the aqueous solubility of the salt is not sufficiently high, co-solvents may need to be added to enhance solubility (e.g. propylene glycol is used as the vehicle in phe-nobarbitone sodium injection). Parenteral solutions based on co-solvent vehicles normally cannot be directly injected intravenously because there is the risk of precipitation at the injection site. Therefore, such products are diluted with isotonic saline or 5%w/v dextrose solution to produce a lower concentration that remains soluble and can be safely administered by infusion. Alternative delivery routes are by subcutaneous or intramuscular administration by which, in... 

The knowledge of medications mechanism of action and receptor modulation may provide a conceptual framework for rational medication choice. A mechanistic approach and multimodal medication administration utilizing the synergistic effects of the aforementioned medications may provide the most effective analgesic regimen. Figure 11.4 represents the pain pathway and the site within the pathway where the medications have their effect. 

ASSESSING THE ADMINISTRATIVE UTILITY OF THE QSAR INFORMATION SYSTEM... 

Administrative utility. Environmental Contaminants Act, information, legal framwork, QSAR Information System, toxic substances management. 

Crowley, M., Sasseville, J.L. and Couture, P. 1986. Evaluation of the administrative utility of information generators in managing toxic substances the case of theQSAR Information System. J. Environmental Management, submitted. 

In 1981, Chinese Restaurant Asthma was reported following capsule administration of MSG to several asthmatics (37). However, the researchers failed to account for other allergens to which the subjects could have been exposed and did not utilize the scientific practice of a "control" substance which would have helped to determine if glutamate triggered this response. In a double-blind crossover study, chronic asthmatics were challenged with MSG or a placebo. No decrease in pulmonary function was observed (39). 

Eventually, the proposed method was successfully applied to quantify clarithromycin in spiked human plasma and real samples from healthy volunteers after oral administration of the dmg indicating the utility of this method for clinical and bioavailability studies. 

A wide variety of animal species are subjected to the administration of drugs during their lifetime.The various animal species can encounter drugs and other dietary additives by different routes and this is dependent on the environment in which they are kept. Intensively reared animals tend to have considerable consistency in the components of their diets and thus are much less likely to encounter the range of naturally produced compounds that extensively produced animals encounter. The desire for less expensive dietary constituents and increased efficiency of use has induced feed manufacturers and producers to add enzyme supplements to diets of most farmed animals to reduce the negative effects of indigestible dietary carbohydrates, refactory proteins and unavailable minerals such as phosphorus. This use of dietary additives to improve nutrient utilization and environmental consequences of feeding animals intensively has been the subject of intense research activity in the last five years. " The... 

If the area and eorridor ean be maintained free of safety hazards arising from the hazardous waste operation, the work probably would not fall under the requirements. In this ease, the area and eorridor would eonstitute a temporary support zone. Beeause the work involves eleetri-eal utilities, it would fall under the most proteetive standard of praetiee, sueh as OSHA s Eleetrieal Standard or the National Eleetrie Code (NEC). Also, there may be other requirements that apply. Administrative eontrols sueh as HAZWOPER-trained eseorts are used to make eertain that the utility workers are not exposed to any hazards from the operation. The proeedures to be followed are doeumented in the site-speeifie HASP [1]. 

Meridian Corporation. (1986). Waste-to-Energy A Primer for Utility Decision-Makers. Golden, CO Western Area Power Administration. 

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