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When the submission includes long-term stability studies on three batches of drug product covering the proposed shelf life, a postapproval commitment is unnecessary. If, on the other hand, when at the time of approval long-term stability data for the primary batches of drug product do not cover the proposed shelf life granted, a commitment should be made to continue the long-term stability studies (and sixmonth accelerated stability study if not performed), postapproval, to rmly establish the shelf life. If the submission includes data from stability studies on fewer than three production batches (batches manufactured at production scale by using production equipment in a production facility as speci ed in the application), a commitment to continue long-term studies through proposed shelf life and accelerated studies for six months for a total of three batches should be made. If the submission does not include stability data on the production batches, a commitment should be made to place the rst three production batches on long-term stability studies through the proposed shelf life and accelerated studies for six months. When signi cant change occurs in the accelerated stability study on the primary batches (requiring a study under intermediate conditions), stability of commitment batches can be conducted at either the accelerated or intermediate condition. On the other hand, if a signi cant change occurs for the commitment batches under the accelerated condition, testing at the intermediate storage condition is also required for commitment batches. A formal stability commitment protocol should be in place for primary and commitment batches [7]. 7.1.5.7 Storage Statement and Labeling



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With all the excitement about Linux and its penetration of almost every area of modern computing, it s natural to step back and think, Why should I care It s just another operating system The following is a list of the most significant advantages of Linux over other operating systems: Multiprocessing, multiuser operating system: Other desktop computer operating systems, such as Microsoft Windows, started out as small operating systems that could only run one program at a time, and have been retrofitting the ability to run multiple programs at the same time ever since Linux draws upon decades of computer science research in Unix, the effective use of hardware, how to run and service multiple programs at the same time, and general computer performance, and was created with these things in mind No retrofitting necessary.





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In the top section, Notification Settings, choose one of the following: Disable standards notifications: No real-time notification of standards violations. You can still check standards using the Check Standards dialog box at any time. Display alert upon standards violation: Displays a message if your drawing is associated with a standards file and you make a change that puts the drawing in noncompliance with the standards file, as shown in Figure 26-14. Display standards status bar icon: Displays an icon on the AutoCAD status bar. The icon has an exclamation point if there is a nonstandard object in the drawing. A balloon appears to notify you that a standards violation has occurred. Click the Run Check Standards text or the icon to open the Check Standards dialog box so that you can fix the problems. Figure 26-14: The alert message notifies you of a standards violation.

FIGURE 3.24. Main elements for polarization diffraction interferometer for phase shifting interferometer.

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Always free and available source code: This includes the Linux kernel and all of the components of a core Linux distribution For many home computer users who just want an off-the-shelf operating system that does the right thing, this doesn t matter directly However, by making it possible for many different companies and groups to create, distribute, and maintain Linux distributions that are easy to install and use, freely available source code is the cornerstone of Linux availability Linux distributions may include closed source applications, such as RealPlayer, that run on Linux, but the source code for the Linux kernel and the vast majority of Linux software is and will always be readily available No lock-in to a specific vendor: Regardless of the operating system that you re currently using, you may have encountered problems with applications or the way things worked.

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