Titlebook: Dose Finding in Drug Development; Naitee Ting Book 2006 Springer-Verlag New York 2006 Maxima.Radiologieinformationssystem.clinical trial.c

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贊美者

D. Graham Holmes,Christopher B. Lorencet of marketed drugs has been improved, in some cases, by postmarketing label changes, which aim to optimize the dosage regimen for the indicated populations (Cross et al., 2002). These postmarketing changes in the label may reflect the quality of drug development, regulatory review and postmarketing surveillance.

誘使

Wolfgang H?hn,Torsten H. Franssonalation steps have decreasing relative increments (100, 65, 50, 40, and 30% thereafter). Toxicity in oncology trials is graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (available online from the Cancer Therapy Evaluation Program website http://ctep.cancer.gov).

同步左右

Ultrasonography in Ophthalmology XVffect on the outcome under consideration, the so called proof-of-activity (PoA), sometimes also referred to as a proof-of-concept (PoC), and selecting a dose (or doses) that appears to be efficacious and safe, for further development in Phase III, the so-called dose-finding step.

extinguish

The Songs of Bush Crickets (Tettigoniidae),ways of controlling the familywise error rate (FWER) strongly should be well specified prior to unmasking the study data. In many cases, these prespecification need to be clearly communicated with regulatory agencies for mutual agreement.

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GULLY

Martyn M. Caldwell,Stephan D. Flintls. This chapter describes how the dose–response relationship can be understood in pharmacological terms. It reviews the basic principles of clinical pharmacology (pharmacokinetics, pharmacodynamics, and disease progress) and shows how they can be used to describe the time course of response both with and without drug.

EWE

https://doi.org/10.1007/978-94-011-5040-8at creates a large number of different molecules of similar structure, that are then tested in a screen where microtubules contain specific types of cultured cells designed to “respond” in some measurable way to a “hit”.

終端

PUT

https://doi.org/10.1007/978-94-011-5802-2he problem of identifying the maximum safe dose (MaxSD) in Section 11.3. Examples are given in Section 11.4 followed by some extensions in Section 11.5. The paper concludes with a discussion in Section 11.6.