preclinical white papers and articles
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Phase I Studies: From First Drug Design To First-In-Human Studies
5/8/2017
Phase I is often seen as the gateway between scientific research and clinical medicine, and the outcome of the trials have a major impact on the next steps of any prospective drug.
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Precision Medicine In Immuno-Oncology
5/4/2017
The ongoing advances in cancer immunotherapy together with precision medicine may promise a bright future for patients. Learn about the two most common biomarkers in clinical trials that are critical for the drug development process.
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The Importance Of Stakeholder Research In Rare Disease Drug Development
10/27/2016
Leading manufacturers increasingly employ stakeholder research early in development to better identify the needs of patients and providers.
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Advancing Safety and Efficacy Studies with Novel Surgical Applications
7/8/2016
Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration, and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.
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Understanding The True Value Of Your Biopharma Product With Earlier Intelligence
6/23/2016
In the initial stages of drug development, it is natural to focus on a compound’s novel mechanism of action and potential implications in a therapeutic area. Yvonne Spark, Consultant, Covance Market Access Services
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On-Site Manufacturing In Early Clinical Drug Development (In Europe)
3/13/2015
Early drug development requires adherence to Good Manufacturing Practices (GMP) guidelines when manufacturing investigational medicinal products (IMPs) for clinical studies conducted within Europe.
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Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs
3/3/2015
Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.
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Catching Up With The Consumerization Of Technology In The Clinical Trial World
2/21/2014
Not too long ago, a clinical operations professional likely enjoyed more powerful technology capabilities at the office than at home. She had a sophisticated email infrastructure, shared calendaring, a high-speed network and maybe a Blackberry.
At some point during the last 15 years this trend flipped. Suddenly people had better tools in their personal lives and the limitations of their office tools became apparent by comparison – for example, systems that won’t talk to each other, small inbox quotas, file size attachment restrictions, slow email searches and difficult file sharing. Meanwhile, consumer technology rapidly became more sophisticated, available and accessible with collaborative cloud-based tools, personal devices and similar applications to improve the efficiency of everyday tasks.
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Importance Of Preclinical Imaging In Drug Discovery
5/6/2013
The process of discovering and bringing a drug to market consists of several stages, beginning with identification and validation of a drug target and continuing through lead identification by high-throughput screening, lead optimization, and profiling in relevant disease models.
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Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety
4/10/2013
Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo