Dosing unit

Transfusion-induced autoimmune disease has been a significant complication in the treatment of patients who require multiple platelet transfusions. Platelets and lymphocytes carry their own blood group system, ie, the human leukocyte antigen (HLA) system, and it can be difficult to find an HLA matched donor. A mismatched platelet transfusion does not induce immediate adverse reactions, but may cause the patient to become refractory to the HLA type of the transfused platelets. The next time platelets with an HLA type similar to that of the transfused platelets are transfused, they are rejected by the patient and thus have no clinical efficacy. Exposure to platelets originating from different donors is minimized by the use of apheresis platelets. One transfusable dose (unit) of apheresis platelets contains 3-5 x 10 platelets. An equal dose of platelets from whole blood donation requires platelets from six to eight units of whole blood. Furthermore, platelets can be donated every 10 days, versus 10 weeks for whole blood donations. 

Labeling. Labeling, controUed by FDA regulations, includes not only the affixed labels, but also the package inserts that provide mote detailed information. Trade, generic, or common name, dose, number of dose units present, and name and address of manufacturer and distributor ate requited. For nonptescription products, adequate directions for use ate requited. Prescription products must beat the phrase, "Caution Federal law prohibits use without a prescription" on theit labels. 

Table 15. Conversion factors for frequently reported damage dose units...

Previous Epoetin Alfa Dose (units/week) Weekly Darbepoetin Alfa Dose (mcg/week)... 

Concentration (units/mL) Volume (mL) Dose (units) Cumulative Dose (units)... 

Fig. 10 Blood level versus time profile simulations following (A) a single dose representing 100 units of a drug from a rapidly releasing dosage (B) Three divided ddoses of 33 units each from the same rapidly releasing product and (C) a single 100 unit dose from an optimized controlled-release dosage form. A hypothetical effective level (80 units) and toxic level (160 units) are depicted. The dosing units are typically in mg and the blood level concentration units in pg or ng.

Dirt content Dosing units for deter- Macro Non MST UD... 

Timers Torque Valves, dosing units No MST until now P... 

It should be noted that these considerations apply strictly to the consumables element. In the operation of a chemical dosing unit there is the additional fixed cost of manning the operation which, as noted above, is negligible for the catalytic reactor and process. 

Pharmaceutical powder is a mixture of finely divided drugs and/or chemicals in dry form. They are dispensed as bulk powders or divided powders. When the prescription is received for powders, first determine whether it is based upon one unit or upon a bulk formula to be subdivided into individual units. Bulk powders are provided as multiple doses in a container and the patient measures the dose as instructed at the time of administration. Some examples of bulk powders include Tolnaftate Powder USP and Nystatin Topical Powder USP as antifungals, and Desitin Powder for diaper rash. Divided powders are meant to be provided as single dose units in individually wrapped powder papers. Such single dose packets are stacked in a powder box, and the label... 

Studies in which dose units could not be expressed as mg/cm2/kg have their dose units listed following the dose levels. 

The upper bound on lifetime risk can easily be estimated by multiplying the cancer potency by the number of dose units individuals are, or could be exposed to each day. This multiplication constitutes the quantitative component of risk characterization (Step 4) for carcinogens. That is, if potency has units of upper bound on lifetime risk per unit of dose, and we multiply it by number of dose units, the result is upper bound on lifetime risk. This is the mathematical form of what we are doing when we are reading the risk directly from Figure 8.1. 

TEM instruments and the improved operation procedures using devices such as a Minimum Dose System (MDS JEOL Ltd.) or a Low Dose Unit (LDU Philips) [2,3],... 

Fig. 7 Extruder and extrusion. 1 Drive unit, 2 barrel inlet, 3 temperature control, 4 feed hopper and dosing unit, 5 vacuum vent, 6 barrel, 7 screw. (Reproduced with permission from Reifenhauser)...

Brand Name Salt Form mEq Potassium/ Dosing Unit... 

EMLA cream (lidocaine (lignocaine) 2.5% and prilocaine 2.5%) is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1 1 by weight. It is available in 5 g and 30 g tubes. It is also available as an anaesthetic disc. This consists of a single-dose unit of EMLA contained within an occlusive dressing. The disc contains 1 g EMLA emulsion, the active contact surface being approximately 10 cm2. The surface area of the entire anaesthetic disc is approximately 40 cm2. EMLA (1 g) contains lidocaine 25 mg, prilocaine 25 mg with thickening agents, water, NaHCOB, etc., at a pH of about 9. 

Inhalant 110, 220 mcg/actuation in 14, 30, 60, 120 dose units Triamcinolone (Azmacort)... 

Varicella Varicella-zoster immune globulin Weight (kg) Dose (units) Postexposure prophylaxis (preferably within 48 hours but no later than within 96 hours after... 

ED 50 the median effective (therapeutic) dose - units of mg/kg body weight LDso the median lethal (fatal) dose - units of g/kg, mg/kg, mg/kg LCso the median lethal concentration - units of ppm, mg/L TDso tile median toxic dose... 

The SUPAC-IR guidance suggests that a pilot-scale batch be, at minimum, one-tenth that of full production scale or 100,000 dose units (tablets or capsules), whichever is larger. If the dose of drug T was 100 mg, a 10-kg batch will, in theory, produce 100,000 units but will not meet the production-scale criteria. The origin of the production-scale criterion was intended primarily to ensure that the pilot batch was manufactured by a procedure fully representative of and simulating that used for full manufacturing scale (e.g., heat and mass transfer efficiency). 

A change in the size and/or shape of a container containing the same number of dose units, for a nonsterile solid dosage form. 

A group of 20 males and 20 females received com oil alone and served as vehicle controls. Squamous-cell carcinomas of the forestomach were observ ed in 45/50 low-dose males, 33/50 high-dose males, 40/50 low-dose females and 29/50 high-dose females, while none was observed in controls. The lesions, seen as early as week 12, were locally invasive and eventually metastasized. A significantly higher incidence of haemangio-sarcomas of the spleen was observed in low-dose males (0/20 controls, 10/50 low-dose and 3/49 high-dose) (United States National Cancer Institute, 1978). 

The active substance is mechanically ejected from a blister through laser-drilled nozzles with a diameter of a few pm and integrated into the blisters by means of punch, to produce a mist consisting of drops measuring 1-6 pm. The blister is inserted into an electronically controlled dosing unit that measures the airstream and induces aerosolization in synchrony with inspiration. The bioavailability of morphine sulphate (total dose 8.8 mg) blistered in portions of 1.2 mg was 75% of that on intravenous administration (dose 4 mg), which is much higher than conventional aerosol formulations (Gonda et al., 1999 Otulana etal., 1999). 

Figure 17 AerX pain management system the single-dosed active substance solution in the blister is aerosolized by means of a punch through the laser bored nozzles. The blister is inserted into a dosing unit controlled by a microprocessor. Aerosolization is induced by the punch (actuation), when the dosing unit measures a sufficient inspiratory stream and the mist is synchronized with inspiration.

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