Drug development tool

In addition, IR solid oral dosage forms are categorized as having rapid or slow dissolution. Within this framework, when certain criteria are met, the BCS can be used as a drug development tool to help sponsors justify requests for biowaivers. 

Food Drug Administration (2014) Guidance for Industry and FDA Staff Qualification Process for Drug Development Tools (FDA Maryland). 

FDA. (2014a). Guidance for Industry and FDA Staff —Qualification Process for Drug Development Tools. Available at http //www.fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm230597.pdf (accessed October 20, 2015). 

In 2014, the FDA issued a guidance document on the qualification of drug development tools (DDTs) (FDA, US Food and Drug Administration, 2014) that included biomarkers within its scope and detailed a process for qualifying DDTs for potential use in multiple clinical drug development programs within a specified context of use (COU). Specific... 

Critical Path Institute webinar series (2014). Approaches to Statistical Analysis for Biomarker Qualification Defining the Components to Drug Development Tool (DDT) Qualification . Seminars archived at http //c-path.org/approaches-to-statistical-analysis-for-biomarker-qualification-defining-the-components-to-drug-development-tool-ddt-qualification/ (accessed October 23, 2015). 

FDA. Drug development tools (DDT) letters of support. 2015b. Available at http //www.fda.gov/Drugs/DevelopmentApproval Process/ucm434382.htm Accessed on 20 May 2015. 

To extract the conformational properties of the molecule that is being studied, the conformational ensemble that was sampled and optimized must be analyzed. The analysis may focus on global properties, attempting to characterize features such as overall flexibility or to identify common trends in the conformation set. Alternatively, it may be used to identify a smaller subset of characteristic low energy conformations, which may be used to direct future drug development efforts. It should be stressed that the different conformational analysis tools can be applied to any collection of molecular conformations. These... 

Preparative chromatography has been used for chiral separations for years, but examples of multi-kg separations (and hence larger ones) were rare until recently. The development of SMB techniques (both hardware and simulation software) has made major breakthroughs in this field. The ability of SMB as a development tool has allowed the pharmaceutical manufacturer to obtain kilo grams quantities of enantiopure drug substances as well benefit from the economics of large-scale production. 

Whitebread, S., Hamon, J., Bojanic, D., and Urban, L. (2005). In vitro safety pharmacology profiling An essential tool for successful drug development. Drug Disc. Today 10 1421-1433. 

Pharmacogenetics as a Compound Selection Tool in Drug Development... 

Several excellent reviews have appeared recently (Condon et al. 2005 Huang et al. 2006 Koch and Narjes 2006 Meanwell et al. 2005 Neyts 2006 Shim et al. 2006 Wu et al. 2005), which summarize the development of agents to treat HCV infection. In this report we highlight the application of modem drug discovery tools and techniques to inhibit HCV replication by describing selected examples that have appeared recently in the scientific literature. 

The tools for in silico toxicology are broadly applied in the drug development process. The particular use of the tools is clearly context-dependent, which includes the quality of the prediction and the applicability domain of the model. 

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