Across the spectrum of therapeutic indications, typically, the majority of new investigational drugs are evaluated in randomized dose-ranging clinical trials. These types of clinical trials enable a reasonable understanding of…
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It’s common knowledge that every approved drug on a pharmacy shelf must undergo extensive testing to demonstrate safety and efficacy. However, there is much more that goes into the approval…
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A complex biochemical “dance” occurs between the body’s natural processes and the chemical composition of pharmaceutical drugs when taken by humans. These complicated interactions are measured and described using pharmacokinetic…
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Because of the importance of clinical pharmacology to drug development, it is essential to consider the expertise of your product development team early and to determine whether additional clinical pharmacology…
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CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…
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Content updated on April 21, 2021 An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for…
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As Physiologically Based Pharmacokinetic (PBPK) modeling becomes more widely used in regulatory submissions, there are some common misconceptions that have been brought to our attention. We would like to dispel or…
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