microbe 发表于 2025-3-21 17:15:59

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代替 发表于 2025-3-21 20:22:50

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骂人有污点 发表于 2025-3-22 01:57:09

New Drug Development,novel chemical compound, i.e., a new chemical entity (NCE) or new molecular entity (NME), as its active ingredient. In the case of biologicals, attention focuses on proteins that are produced via the large-scale cultivation of microbial or mammalian cells.

MELD 发表于 2025-3-22 06:21:09

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BOLUS 发表于 2025-3-22 08:52:53

Sample Size Estimation, an understanding of important concepts, including statistical significance and clinical significance, before reading about sample size estimation. Addressing sample size estimation at this point also allows a whole (short) chapter to be dedicated to this topic, thereby acknowledging its importance in clinical research.

沉着 发表于 2025-3-22 14:46:51

Cardiac and Cardiovascular Safety Assessments,ng). In this chapter discussions focus on analogous evaluations in humans if a sponsor decides to move the drug molecule into clinical trials. At this point, the term investigational drug can be adopted.

寡头政治 发表于 2025-3-22 19:43:04

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ACE-inhibitor 发表于 2025-3-22 23:20:37

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Hemoptysis 发表于 2025-3-23 05:19:21

General Safety Assessments,cussions of safety now move to safety assessments in clinical trials. This chapter discusses general safety assessments, and Chapter 14 addresses specialized cardiac and cardiovascular safety assessments that have recently become critical components of new drug development. Postmarketing surveillance is discussed later in Chapter 16.

LUDE 发表于 2025-3-23 07:34:32

Manufacturing Small Molecule Drugs and Biologicals,l. Successfully producing the drug candidate for nonclinical testing and clinical trials and manufacturing the drug for postapproval marketing are critical. Moreover, their complexity and difficulty should not be underestimated.
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查看完整版本: Titlebook: New Drug Development; An Introduction to C J. Rick Turner Book 2010Latest edition Springer Science+Business Media, LLC 2010 Clinical.Develo