An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been…
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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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The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
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In recent weeks, the world has welcomed very positive and much anticipated news on the COVID-19 vaccine front. At least two high-profile vaccines (mRNA vaccines from Pfizer/BioNTech and Moderna) have…
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Inaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity…
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What is Cellular & Gene Therapy? Genes are defined by the NIH as the “basic physical and functional unit of heredity.” We receive these valuable sequences of DNA from our…
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What is PBPK Modeling & Simulation? Physiological based pharmacokinetic modeling and simulation (PBPK) is a computer modeling approach that incorporates blood flow and tissue composition of organs to define the…
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