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Pharmaceutical companies drug development

Often, the challenges experienced by an ethical pharmaceutical company in development of water-insoluble drug products revolve around the following factors ... [Pg.639]

An example of improved efficacy of an enantiomerically pure version of a drug over the racemic version is provided by citalopram. The racemic version, known as Celexa, is marketed as an antidepressant. Studies on the resolved enantiomers have shown that the S-enantiomer is the active one and that it has a more rapid onset of action and a more favorable benefit-to-risk ratio than the racemate. As a result, (S)-citalo-pram (escitalopram or Lexapro) is now being marketed. Not only is this a better and safer drug, but the pharmaceutical company that developed citalopram was able to extend its markel exclusivity for an additional 3 years. [Pg.244]

The FDA is hampered not only by its own internal failures, but also by its reliance on the potentially fraudulent activities of the pharmaceutical companies in developing and marketing their products. Because the FDA never evaluates the primary data generated by the drug companies,... [Pg.372]

If a pharmaceutical company is developing a new antihypertensive medication targeted for chronic use, then preparing a submission with a goal of having the drug prescribed is an accom-... [Pg.293]

A pharmaceutical company has developed an antihypertensive drug that is theorized to lower diastolic blood pressure when given to subjects with moderate to severe hypertension. If the diastolic blood pressure were constant under given conditions, then failure to lower diastolic pressure... [Pg.314]

The purpose of this book is to highlight the problems associated with the production of chiral compounds on a commercial scale. With the movement by pharmaceutical companies to develop single enantiomers as drug candidates, the focus has turned to problems associated with this subclass of organic synthesis. The major classes of natural products are also discussed since the stereogenic center can be derived from nature through the use of chiral pool starting materials. [Pg.393]

Variable commercial potential for both a rare and common disease. Virtually every pharmaceutical company that develops an orphan drug hopes that the drug will be found useful in treating a more common disease. This seldom occurs for a truly novel drug. [Pg.205]


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