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Dr Steven R Koepke spent nine years at the FDA as a reviewer and then deputy director of one of CDER s divisions of new drug chemistry Now he works in the heart of Washington, DC at a contract research organization called PharmaNet, Inc, one of those new consulting firms, like Alquest, that help pharmaceutical makers navigate the application process Burly and silver-haired he looks like he would be more comfortable out on a farm than in his firm s half-empty luxury offices Koepke explained what he used to analyze: In terms of chemical composition, he would need the paperwork from three different lots of the drug He would have to make sure that the correct amount of each ingredient went into the drug, and also that it was kept at the right temperature during each stage of preparation.

for some quotient polynomiald (x).Let S be the degree of d (x). The degree of d ( x )(x2'-1 1) is 6 21 - 1. The degree of a ( x ) is 11 - 1 < 21 - 1, so the degree of a ( x ) x b b ( x ) must be established by the degree of x b b ( x ) . That is, we must have

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not have the cachet of some of his more cosmopolitan colleagues and certainly could not afford the playboy life of a scienti c dilettante. He was a practical man, an of cer of the Corps de Ponts & Chauss es whose day-to-day work concerned the utilitarian business of building roads and bridges. What s more, he had shown himself to be anything but politically astute, opposing Napoleon s return from Elba, which earned him a short spell in prison. Just as Euler had been snubbed by the Prussian king, so the down-toearth Fresnel was dismissed by the Parisian scienti c establishment. Even when Fresnel presented his carefully devised equations showing how waves of light could produce the fringes at the edge of shadow, there were those who could not accept that a mere road-builder could be capable of such original thinking. Fresnel ignored them and went systematically on with his investigations, unknowingly echoing Young in getting help from the village blacksmith in constructing his apparatus. But while experiments were at the heart of Young s work, Fresnel was a more accomplished mathematician and could back up his theories with a polished analysis. One of Fresnel s critics was the mathematician Sim onDenis Poisson. Poisson not only moved in the right social circles, but he also knew his stuff, making wide-ranging contributions to science and maths as the rst holder of the chair of mathematics at the Sorbonne. He found Fresnel s work ludicrous. To show how absurd his fellowFrenchman s calculations were, Poisson predicted, using

The left-hand Styles For box contains every type of tag you could ever want to color. Just select a tag type and then click the color swatch to select one of the 216 colors displayed in the color picker. After the color picker opens, you can also choose the small palette icon to select from the full range of colors available to your system. The color picker also enables you to use the Eyedropper tool to pick a color from the Document window. As you change colors, you can see a preview of how your code looks in the Preview window.

(There is an allowable range for each of those measurements) He also examined the manufacturing plant: What chemical suite [room] was it made in, and what was being made in the suite next door You want to make sure the room is enclosed so you don t get cross-contamination For a typical NDA, it would take him three or four days just to read through his set of 3 to 12 volumes and take notes on what looked good, what looked like a problem, and what the key issues were The ultimate goal of the whole review is determining what the drug s label may claim regarding the allowed uses, dosages, and side effects (The technical term label is a little misleading: This is not like the label on the outside of a can of soup.

Safety analysis of this model detects no deadlocks or errors. The m i ~ ~ LT d e for the model is depicted in Figure 11.2. This confirms that the model computes the primes between 2 and 9 and that the program terminates correctly. In fact, the concurrent version of the primes sieve a l g o r i t ~ does not ensure thatalltheprimesbetween2and MAX arecomputed: it computesthefirst N primes where N is the number of filters in the pipeline. This can easily be confirmed by changing MAX to 11 and re-computing the minimizedLT ,which is the same as Figure11 $2.To compute all the primes in the range 2 to 11, five filters are required.

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