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The rst reaction is a bromination that is designed to add one bromine to an aromatic ring but can overreact to add a second bromine The possibility of reduced selectivity caused by differences in micro- and mesomixing on scale-up must be investigated Marco calls one of his associates, Roger, who has looked into this issue in previous developmental studies Roger advises that the rst issue is to decide if the reaction could be in uenced by mixing or is reaction-rate controlled Despite some grumbling that Mixing cannot affect homogeneous reactions, so why are we doing this a geometrically similar 4 liter reactor is set up to study high and low levels of mixing with two feed strategies: addition at the impeller for the high-level case and addition at the surface for the low-level case No signi cant difference is observed in the amount of overbromination.

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do not impact the review process Woodcock added, They have the right to contact their government They re citizens, too Similarly, Lester Crawford said that when one of those hundreds of congressional letters arrives, the letter goes to the Office of Legislation [the FDA s political office], which prepares a response for my signature or the center director s signature or the office director s signature Only if the FDA official needs more information would he or she call the staffer who is actually reviewing the drug But in fact, the political calls sometimes do hit the drug reviewer directly It happened to Steve Koepke three times in his nine years as a reviewing chemist and midlevel manager at the FDA, from 1992 to 2001 Koepke is the husky chemist who looks like a farmer, now with PharmaNet.

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Everyone s rst reaction is to jump to the conclusion that there are no mixing issues for this reaction, as was predicted by the grumbling skeptics Roger warns that in some cases, a laboratory experiment might not reveal a signi cant difference because the blend time and micromixing on this scale could be suf cient to mask the problem He proceeds to recommend further experiments: a reverse addition in which A is added to a solution of the brominating reagent instead of the brominating reagent being added to A, as the chemist s procedure speci es The skeptics again object even more forcefully because it is obvious that this is no way to run the reaction Marco asks Roger to explain his reasoning This extreme change will almost certainly reveal whether or not there is potential for overbromination since A is added into a sea of bromine reagent.

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All three times that he faced drug company pressure, he said, he was called into the commissioner s office and hooked up to a conference call with a congressional aide The first time, when Koepke was a reviewer, his supervisor came as well As Koepke recounted it, the congressional aide always said something like, This guy [pharmaceutical executive] is a good member of my district Why are you beating up on this drug Like virtually everyone else who was even willing to discuss this topic, Koepke would not reveal which drugs, members of Congress, or companies were involved, but the commissioner in all of his examples happened to be Michael Friedman, he said Under the gun, Koepke was scared Just going in front of the commissioner had me in such a state you don t go in front of the commissioner very often.

This will exaggerate any overreaction Roger notes that the 1 : 1 mole ratio will be maintained once the addition is completed He also reminds Marco that even a small amount of dibromo (<1%) could be a problem since scale-up will increase the overreaction unless precautions for adequate mixing are recognized and taken After some consideration, Marco decides that it is easier and cheaper to run the reverse addition experiment than to run the risk of overbromination The reverse addition revealed overreaction, indicating to Roger that further testing on a pilot plant scale would be required After determination of the reaction rate ratio, k1 /k2 , Roger was concerned that successful scale-up in a stirred vessel might not be feasible because the consecutive overbromination reaction was relatively fast A high-energy pipeline mixer reactor might be required for manufacturing.