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REACTION WITH ELECTROPHILES: HYDRIDE ABSTRACTION AND HYDRIDE BRIDGING The C H bond is normally not very basic and will not interact with Lewis acids as a rule. However, in the presence of very powerful Lewis acids, such as carbocations, or if substituted by powerful p electron donors (X: or ``C'' substituents), hydride abstraction from a carbon atom may be accomplished, corresponding to an oxidation of the C atom. Activation by p Donors (X: and ``C'' Substituents) Abstraction of a hydride from carbon is almost invariably an endothermic process. The rate of the reaction depends on the stability of the transition structure which closely resembles the product carbocation and is expected to be stabilized by the same factors, among them, substitution by X: and ``C'' substituents. Nevertheless, initial interactions set the trajectory for the hydride abstraction reaction. The interaction of a C H bond with a ``C'' substituent is shown in Figure 10.7b. The feature relevant to the present discussion is that the HOMO which involves some admixture of the C H bond has been raised in energy. Therefore, attack by electrophiles, while most likely at the p bond of the ``C'' substituent, is also possible at the C H bond. The interaction of an X: substituent with a CH bond is shown in Figure 10.7a. In general a single X: or ``C'' substituent is not su cient to activate the C H bond toward hydride abstraction. Hydride Abstraction The interaction of a C H bond with a strong Lewis acid (low-energy LUMO) is shown in Figure 10.8a. The p orbital of a carbocation as the LUMO is shown by way of example. Examples of hydride abstraction reactions are shown in Scheme 10.1.

To create a lookup parameter and action, follow these steps: 1 In the Block Editor, add another parameter and action that you will use as the basis for the Lookup parameter and action For example, add a linear parameter and a stretch action If you add a value set (list or increment), the measurements will be available in advance when you create the lookup table 2 From the Parameters tab of the Block Authoring Palettes, add a lookup parameter 3 From the Actions tab, add a lookup action At the prompt, select the lookup parameter and place the lookup action The Property Lookup Table dialog box opens 4 Click the Add Properties button, choose the parameter that you want to work with (for example, the linear parameter), and click OK You return to the Property Lookup Table dialog box, as shown in Figure 18-21 5.

(5.11)

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(a) Accepting and validating drug products that failed to meet established standards or speci cations and any other relevant quality control criteria (i.e., dissolution rates, content uniformity, purity, potency) and then falsely recording the untruthful data as if the drug products did not fail (b) Accepting and validating the stability characteristics of drug products and then falsely recording the untruthful data as if the drug products did not fail (c) Documenting the examination and review of labels, when in truth and fact no review occurred (which results in inaccurate labels distributed with drugs) (d) Falsely documenting any components of master production and central records (e) Falsely documenting any component of the batch production and control records (f) Falsely describing testing methods when no (or inadequate) testing methods were performed (g) Failing to accurately make a written record of all written and oral complaints regarding a drug product and/or certifying that investigations were performed when they were not, falsely certifying that the ndings were negative when they were not, and so on (h) Falsifying records which would indicate manufacturing changes which require approval by the FDA (i) False representations that contain statements of fact in correspondence sent to the FDA addressing violations in an inspector s form 483 The FDA typically initiates progressive enforcement, as described in Figure 7. Once the FDA and DOJ decide to bring enforcement action, the U.S. courts have held that the FDA s interpretation of its cGMPs is entitled to substantial deference. As long as the FDA s interpretation of its regulations are reasonable and sensibly conforms to the purpose and wording of the regulations, courts are required to follow the FDA s interpretations. 1.2.4.2 Civil Proceedings

If you have values from a value set, you can see them by clicking the first row in the Input Properties side of the dialog box A drop-down arrow appears Choose the first value If you don t have a value set, you can enter values on each row Click the same row on the Lookup Properties side of the dialog box and enter the label that corresponds with the value For example, in Figure 18-21, the label was Desk Chair Then click the next row, choose the next value, and enter the next label Continue until you re done 6 Click the lower-right cell in the dialog box, which says Read Only by default; it changes to read Allow Reverse Lookup (To do this, all of the rows in the table must be unique.

) You need to use this option in order to choose a value from a drop-down list of labels when you insert the block 7 Click OK to return to the Block Editor..

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