Using This Guideline

The proliferation of computers in the production of pharmaceuticals resulted in the U.S. Food and Drug Administration (FDA) publishing the "Guide to Inspection of Computerized Systems in Drug Processing" in 1983. FDA Inspectors have been using this guideline for the past three years to cite firms for their failure to validate their computer systems. 

We can propose to use this guideline to alert us to the potential for liquid/ liquid behavior. For example, we might consider the need to check more thoroughly for liquid/liquid behavior if we replace the 9 by a 6 and either of these test passes. 

Using this guideline we can read off the median survival times by drawing a reference line across Figure 8.3 at S(t) = 0.50 and finding the earliest value of time on the curve below the reference line. We leave it to you to verify the median times of 6 and 16 days for the active and placebo groups, respectively, using this method. 

Look for substituents which are difficult to add. It is often good strategy not o disconnect these at all but to use a starting material containing the substituent. OH and OR are examples. We have already used this guideline for compound (4) (substituent OMe) and for compound (8) (substituent Ph). 

We have already used this guideline in syntheses of compounds (4) (from m cresol), (8) (from biphenyl), and (9) (from salicyclic acid). 

These guidelines are not intended to cover every conceivable case. Where special conditions apply, more specific guidance is provided in the form of annexes to this document which are published separately. Further, as new technologies emerge, different approaches may be called for. Establishments may use this guideline as a basis for the elaboration of specific requirements appropriate to their individual needs. 

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