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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introduction to statistics and illustrates its important rolNew Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidat

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Book 2010Latest editionhis wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug mole

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Statistical Analysis,As noted in Chapter 1, Statistics can be thought of as an integrated discipline that includes several steps:

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Nonclinical Research,egulatory governance, and reports of them are included in regulatory submissions requesting marketing approval. Three areas of investigation are considered here: pharmacokinetics, pharmacology, and toxicology. The scientific rationale of the studies is addressed, along with a summary of appropriate regulatory guidance.

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Designing Clinical Trials, design, conduct, and analysis impose artificial divisions on a process whose very nature is interactive and integrative. However, there is benefit in looking at components separately, since discussions can temporarily focus on one or two of them before illustrating the interrelatedness of all three. This chapter focuses on study design.

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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.