Chemically activated systems with facile

Drugs are chemical entities, precisely measurable and controllable within close tolerances. Tolerances can be established on the product, and within these tolerances one can live with the drug. If the dmg is out of specification, it is beyond these tolerable limits. It is very different for biologics. The [Code of Federal Regulations] definition is that a biologic involves the product, the manufacturing activity, the product facility, and the people. Inherent natural variability exists at every stage of the process, at every element of the system. Some variability is controllable some is never controllable. 

Figure 16.2 Dihydropyridine-pyridinium salt redox system for site-specific and sustained delivery to the brain. The prodrug A is delivered directly to the brain, where it is oxidized and trapped as the prodrug B. The quaternary ammonium salt is slowly cleaved by chemical/enzymatic action with sustained release of the biologically active phenylethylamine C and the facile elimination of the carrier molecule D. Elimination of the drug from the general circulation is by comparison accelerated, either as A or B or as cleavage products...

The PLL program is a mechanism for developing and maintaining information associated with lessons related to preconstruction and construction activities, systemization, operations, and closure of the chemical demilitarization facilities. The majority of lessons learned are captured in the PLL database, which contains considerable information and is potentially an excellent resource for helping to maintain a high level of operational safety and security. However, so much information is present that plant personnel believe it is hard to identify what will be helpful in any given situation. 

One activity that highlights P2 in a model chemical management system is the control of chemicals purchased by a facility. At Pantex Plant this process is implemented through the use of the PX-761 process. The requestor completes the PX-761, Pantex Chemical Request Form, before the chemical is purchased. The form is reviewed by personnel from the Occupational Safety Health Department, Fire Department, Fire Protection Engineering Department, Waste Operations Department and Explosives Safety Department. This review ensures that the chemical is safe for use with the proper controls in place... 

Type of Service. The type of service—quality assurance, methods development, or routine testing—for each instrument or laboratory is a general consideration, as is the question of whether several types of service will be required of the system. A quality assurance laboratory associated with a chemicals production facility has far simpler needs in terms of analytical capability than a methods development laboratory or one that normally analyzes biological samples for pharmacologically active compounds at sub-ppm or even ppb concentrations. On the other hand, the data storage and reduction needs of a quality assurance laboratory are usually much more pressing than those of a methods development laboratory. 

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