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The FDA requires pharmaceutical industries to establish a stability testing program for each drug product [1 3]. Matthews [4] reviews the regulatory situation in Europe. The purpose of the stability program is to design the appropriate procedure to extract the assay data and calculate the shelf life to determine the expiration date of a drug product. The program should be described in a written protocol including all the requirements established by the regulation. The FDA establishes that the requirements to assess stability are the following [1]: 1. A sample size and test intervals for each attribute to be tested should be speci ed based on statistical rationale. 2. The storage conditions for the samples should be speci ed. The storage conditions should be the same as those speci ed in the drug product labeling. 3. All test methods used for each of the drug product attributes need to be quali ed to demonstrate adequacy and reliability. 4. The stability samples should be stored in the same packaging con guration used for the nal drug product to be marketed. 5. If the drug product needs to be reconstituted, testing of the drug product before and after reconstitution should be provided. 6. The number of batches to be used for the stability program for a new drug product is at least three. Different batches of the drug substance should be used. 7. The pharmaceutical industry should maintain records for all data, protocols, and reports related to the stability program. 7.2.1.3 Stability and Shelf Life

Figure 24.17 Tandem dual-system backup schema with two hardware pieces: gateway hardware and ePR server hardware. Each hardware piece has two softwares ePR server software, and gateway software and a tandem database with hard drive for data and metadata archive.

P1: FCH WY050-12 WY050-Ulick-v4 September 19, 2004 12:5

4. The next step in the installation is the security settings screen where you can choose to turn on or off the Windows Update mechanism. It s recommended that you enable this so that your copy of Windows is always kept up-to-date automatically. (See Figure 17-41.) Click Next to continue. 5. Now the Windows Setup Wizard will check to see if you are connected to the Internet and asks for some basic information. See Figures 17-42 and 17-43. Enter this and click Next. Alternatively, you can choose to Skip and enter the details later.

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Up to this point, we ve looked at tools in Reader for views and displays, navigation, finding and searching text, and Web links. As you examine the Reader Command bar, notice that only three editing tools are available. Reader, as a viewer, cannot create or modify text. You can, however, select both text and graphics in Reader. The three tools that appear as editing tools are the Text Select tool, the Column Select tool, and the Graphics Select tool. When the tools are expanded, they appear, as shown in Figure 3-23.

Figure 6.29 The probability distribution functions and their characteristic functions for each of the six test and repair stages. Note that the scales are not uniform.

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For the most part, routers, switches, and hubs are not actually wireless, but are included here because they nevertheless form the basis of the wired LANs that underlie infrastructure and hybrid networks Furthermore, wireless access points frequently include router technology along with their wireless relay and addressing technology Virtually all vendors of wireless networking equipment offer at least one product that combines an access point with a router, resulting in a single small box featuring three or four ports for Ethernet cables, another port for broadband modem hookup, and the wireless components required by the access point, including the antenna Routers and switches perform different functions Today you ll hear the word router more often than switch when it comes to sales of home and small-office networking equipment, but in reality most cable/DSL routers also are switches.

Prerequisites for Other Technologies But plastics are also prerequisite for numerous modern technologies that would not exist without plastics. The transport of electricity is the most famous example. What alternative materials exist for a exible, longlasting insulation The storing of information on polyethylene terephthalate (PET) tapes or on polycarbonate disks is another example. A so-called welfare cost bene t analysis for a huge number of different plastics applications has been carried out by GUA.Geselllschaft f r umfassende Analysen, u Wien, initiated by APME [7].

So far, we have discussed many of the quantum theory concepts. Here we apply in a formal manner these concepts to the a one-electron atom, a multielectron atom, and molecules.

Figure A-35

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