Titlebook: New Drug Development; An Introduction to C J. Rick Turner Book 2010Latest edition Springer Science+Business Media, LLC 2010 Clinical.Develo

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Statistical Significance,ther group, and then see if the responses to the drug are, on average, different from those to the control. Providing a widely accepted answer to the question “Are the responses different?” requires framing the question in statistical language. Statistical techniques can then provide a quantitative

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Clinical Significance,) commented that “presenting .values alone can lead to them being given more merit than they deserve. In particular, there is a tendency to equate statistical significance with medical importance or biological relevance.” Statistical significance must not be equated with medical importance or biolog

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General Safety Assessments,ng surveillance. As noted in Chapter 3, in silico modeling in the discovery phase of synthetic drugs can examine the potential interactions of centers of reactivity in a drug with nontarget receptors, interactions that can lead to undesirable effects. Such studies are intended to modify the eventual

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Efficacy Assessment,g approval, that is, it needs to have a favorable benefit–risk profile. Therapeutic benefit, operationalized as efficacy, is evaluated in therapeutic exploratory and therapeutic confirmatory trials, trials in which the subjects have the disease or condition of biological concern.

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Manufacturing Small Molecule Drugs and Biologicals,odynamic profile, i.e., a profile that indicates it would interact successfully with its target receptor, will not be clinically useful if it does not reach the target receptor in the chemical state necessary to affect a response. Therefore, getting the drug to the microenvironment of the target rec

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Postmarketing Surveillance,rs. These chapters have discussed “engineering safety” into new molecular entities, safety evaluations in nonclinical studies, and safety evaluations in clinical trials. Efficacy is also considered throughout the drug development process, particularly in the discovery phase and then again in therape

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Main Themes and Concluding Comments,have been discussed individually in the preceding chapters, this final chapter takes a more global view. It brings together threads that have run throughout the individual chapters and presents an integrative summary of topics discussed to date. Following these summary discussions, several new topic

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izienter zu sein,. und wenn Marketing das . ist,. dann besteht eine wesentliche Aufgabenstellung einer Marketingstrategie darin, dem Nachfrager ein Angebot zu offerieren, das ihm mehr Nutzen verschafft als alle anderen von ihm in Erwägung gezogenen Konkurrenzangebote. Bei dem Versuch, dieses Ziel zu